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Clinical Laboratories and Pathology Groups

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US Government Purchases 150 Million COVID-19 Antigen Tests from Abbott Laboratories for $760 Million; Only CLIA-Certified Clinical Laboratories Can Do Testing

Abbott sends the SARS-CoV-2 test results directly to patients’ smartphones, which can be displayed to gain entrance into areas requiring proof of COVID-19 testing

There is no greater example that COVID-19 is a major force for change in the clinical laboratory industry than the fact that—though the US federal government pays 50% of the nation’s total annual healthcare spend of $3.5 trillion—it recently spent $760 million to purchase 150 million COVID-19 tests from Abbott Laboratories (NYSE:ABT), an American multinational medical devices and healthcare company headquartered in Abbott Park, Ill., “to expand strategic, evidence-based testing in the United States,” according to the company’s website.

In August, the federal Food and Drug Administration (FDA) granted an emergency use authorization (EUA) to Abbott for its BinaxNOW portable rapid-response COVID-19 antigen (Ag) test. The credit-card sized test costs $5 and can return clinical laboratory test results in minutes, rather than hours, days, or in some cases, weeks, the Wall Street Journal (WSJ) reported.

The test includes a free smartphone app called NAVICA, which enables those tested to receive their test results directly on their mobile devices—bypassing the patient’s primary care physicians.

According to Abbott’s website, the app “allows people who test negative to get an encrypted temporary digital NAVICA Pass, similar to an airline boarding pass. NAVICA-enabled organizations will be able to verify an individual’s negative COVID-19 test results by scanning the individual’s digital NAVICA Pass to facilitate entry into facilities.”

This feature of Abbott’s new COVID-19 test is a good example of how quickly innovation in the medical laboratory testing profession is bringing new features and new capabilities to the marketplace. By marrying the SARS-CoV-2 test with the NAVICA Pass feature, Abbott hopes to deliver increased value—not just to physicians and their patients—but also to employers with employee screening programs and federal government programs designed to screen federal employees, as well as being used for screening travelers at airports and other transportation hubs.

Abbott appears to be banking that in the future such identification will be required to “enter organizations and other places where people gather,” as the company’s website states.

Testing Limited to CLIA-Certified Clinical Laboratories

An HHS news release announcing the government’s planned distribution of the BinaxNOW tests stated that “Testing will be potentially deployed to schools and to assist with serving other special needs populations.”

In the news release, Alex Azar, HHS Secretary, said, “By strategically distributing 150 million of these tests to where they’re needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations.”

The EUA adds that “Testing of nasal swab specimens using [BinaxNOW] … is limited to laboratories certified under CLIA that meet the requirements to perform high, moderate, or waived complexity tests. This test is authorized for use at the [point of care], i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.”

The FDA’s EUA describes the BinaxNOW portable rapid-response COVID-19 antigen test (above) as “a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.” The test costs $5 and Abbott sends results directly to the patient’s smartphone using the free NAVICA app included with the test. (Photo copyright: Abbott Laboratories.)

IVD Companies See Boom in COVID-19 Test Sales

Demand for COVID-19 testing has created opportunities for in vitro diagnostics (IVD) companies that can develop and bring tests to market quickly. 

Recent issues of Dark Daily’s sister print publication—The Dark Report (TDR)—covered IVD companies’ second quarter (Q2) boom in sales of COVID-19 instruments and tests, while also noting a fall-off in routine clinical laboratory testing during the COVID-19 pandemic. 

Abbott Laboratories saw molecular diagnostics sales increase 241% in Q2 driven by $283 million in sales of COVID-19 testing, while rapid diagnostic COVID-19 testing rose 11% on $180 million in sales in Q2, TDR reported, based on Abbott data.

“There is huge economic incentive for diagnostic companies to develop technologies that can be used to create rapid tests that are cheap to perform,” said Robert Michel, Publisher and Editor-in-Chief of TDR and Dark Daily. “In this sense, COVID is a major force for change.”

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” said Jeff Shuren, MD, JD (above), Director of the FDA’s Center for Devices and Radiological Health (CDRH), in an FDA news release announcing the federal government’s $760 million purchase of 150 million Abbott BinaxNOW rapid-response antigen COVID-19 tests. “This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic.” (Photo copyright: The New York Times.)

Abbott Invests in Proving BinaxNOW’s Capabilities

Abbott has a lot riding on the BinaxNOW test. Its portable, rapid molecular ID NOW COVID-19 test was touted by President Trump during a White House press briefing in March as “a whole new ballgame.” But then, researchers at New York University (NYU) published study data that questioned the accuracy and reliability of the test, which Dark Daily covered in “Abbott Labs’ ID NOW COVID-19 Rapid Molecular Test Continues to Face Scrutiny Over False Negatives.”

Thus, Abbott is determined to ensure this product launch is successful and that the test works as promised. According to a news release, “In data submitted to the FDA from a clinical study conducted by Abbott with several leading US research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.”

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, PhD, professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, in the Abbott news release. “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”

Abbott has invested hundreds of millions of dollars in two manufacturing facilities where the tests will be made, John Hackett Jr, PhD, an immunologist and Abbott’s Divisional Vice President Applied Research and Technology, and lead scientist on the BinaxNOW project, told The Atlantic.

“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Charles Chiu, MD, PhD, professor of Laboratory Medicine at University of California, San Francisco, in the Abbott news release. “The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times, and greatly expand access to people who need it.”

However, other experts are not so sure. In the Atlantic article, Michael Mina MD, PhD, Assistant Professor Epidemiology at Harvard’s T.H. Chan School of Public Health, voiced the need to test both asymptomatic and pre-symptomatic people. “This is the type of [COVID-19] test we have been waiting for—but may not be the test.”

Nevertheless, the federal government’s investment is significant. Abbott plans to start shipping tens of millions of tests in September and produce 50 million tests per month starting in October, Forbes reported.

Shifting Clinical Laboratory Paradigms

BinaxNOW will be performed without doctors’ orders, in a variety of locations, and results go directly to patients’ smartphone—without a pathologist’s interpretation and medical laboratory report. This is new ground and the impact on non-CLIA labs, and on healthcare in general, is yet to be seen.

Clinical laboratory managers will want to monitor the rise of rapid-response tests that can be easily accessed, conducted, and reported on without physician input. 

—Donna Marie Pocius

Related Information:

Trump Administration Will Deploy 150 Million Rapid Tests in 2020

In Vitro Diagnostics Firms Report Boom in Sales of COVID-19 Instruments, Tests

FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly from Testing Card

Abbott’s Fast, $5, 15-Minute Easy-to-Use COVID-19 Antigen Test Receives FDA Emergency Use Authorization; Mobile App Displays Test Results to Help Our Return to Daily Life; Ramping Production to 50 Million Tests a Month

Performance of the Rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in Nasopharyngeal Swabs Transported in Viral Media and Dry Nasal Swabs, in a New York City Academic Institution

Trump to Announce Deal with Abbott Laboratories for 150 Million Rapid COVID-19 Tests

Abbott Labs’ ID NOW COVID-19 Rapid Molecular Test Continues to Face Scrutiny Over False Negatives

Abbott Provides Update on ID NOW

A New Era of Coronavirus Testing is About to Begin

U.S. Approves Abbott Labs’ $5 Mass-Scale COVID-19 Test

FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing

While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain Reaction (RT-PCR) tests that detect the presence of SARS-CoV-2, the coronavirus that causes the COVID-19 illness, and for Enzyme-linked Immunosorbent Assay (ELISA) serological tests that detect antibodies present in the blood of people who have become infected with the coronavirus.

However, one LDT that received a lot of media attention was the Sofia 2 SARS Antigen FIA from Quidel (NASDAQ:QDEL), which received an EUA on May 8. The assay is designed to run on the company’s Sofia 2 Fluorescent Immunoassay Analyzer and is the first antigen test for which the FDA has issued an EUA.

As former FDA commissioner Scott Gottlieb, MD, explained on Face the Nation, “this kind of technology is a real game changer … it’s a very rapid test that could be used in a doctor’s office. Doctors now have about forty thousand of these Sofia machines already installed in their offices … you do a simple nasal swab and the test itself scans for the antigens that the virus produces.

“The test is about 85% sensitive. So, let’s say a hundred people come into a doctor’s office who have COVID-19, eighty-five of them are going to be able to be tested positive with this test very quickly. It’s a cheap test. It’ll probably be about five dollars a test and you can get a result within five minutes … you’re getting a very fast result and you can start to take action immediately.

“The company itself said that they’re going to be able to produce about two hundred thousand of these tests starting right away. But in several weeks, they’ll be able to produce up to 1.5 million a week. So, this dramatically expands our testing capacity as long as doctors are able to run these tests in their offices.”

Former FDA Commissioner Scott Gottlieb, MD
In an interview on CBS’ Face the Nation, former FDA Commissioner Scott Gottlieb, MD (above), said, “These antigen-based tests aren’t as reliable, meaning they’re not as sensitive. So, they’re going to miss some patients who have COVID. But in the hands of a doctor who already has a high index of suspicion that the patient may have the disease … they allow you to dramatically expand testing. And they’re very cheap. They’re very easy to perform. And again, most doctors have these machines already in their offices.” (Photo copyright: US Food and Drug Administration.)

Other LDTs That Have Received EUAs

Here’s a look at other laboratory-developed tests from major manufacturers that have received emergency-use authorizations from the FDA:

Abbott Laboratories

Test: Abbott RealTime SARS-CoV-2 assay
Type: Molecular (rRT-PCR)
EUA Issued: March 18, 2020

This test is designed for use with Abbott’s m2000 RealTime system, which is installed in about 200 US medical laboratories, the company says. It can run up to 470 patient samples in 24 hours. As of a May 11 statement, the company said it had shipped more than two million tests in the US.

Test: Alinity m SARS-CoV-2 assay
Type: Molecular (rRT-PCR)
EUA Issued: May 11, 2020

This test is designed for use with Abbott’s Alinity m system, which the company describes as its “most advanced laboratory molecular instrument,” with the ability to run up to 1,080 tests in 24 hours, according to a press release.

Test: ID NOW COVID-19
Type: Molecular
Instrument: ID Now
EUA Issued: March 27, 2020

This is a rapid test designed for use with the ID Now system, a compact portable instrument for point-of-care settings such as urgent care clinics. As of May 11, Abbott said it had shipped more than 1.7 million tests in the US, and that it planned to increase manufacturing capacity to two million tests per month.

However, the test has encountered some stumbling blocks. On May 14, the FDA issued an alert stating that the ID Now COVID-19 test could produce inaccurate negative results. This came after researchers at NYU Langone Health, Northwell Health, and Cleveland Clinic reported problems with the test, according to MedTech Dive. Abbott issued a statement suggesting that the problems were due to improper sample collection and handling, however, the FDA said that Abbott had agreed to conduct post-market studies to identify the cause of the false negatives and suggest remedial actions.

Test: SARS-CoV-2 IgG assay
Type: Chemiluminescent microparticle immunoassay (CMIA) antibody test
EUA Issued: April 26, 2020

This is a qualitative test designed to detect the presence of IgG antibodies following a SARS-CoV-2 infection. The FDA authorized use of the assay on Abbott’s Architect i2000SR system in April, and then followed up with a May 11 EUA for its use on the Alinity i system. In a statement, Abbott said it planned to ship 30 million tests globally starting in May.

Cepheid

Test: Xpert Xpress SARS-CoV-2
Type: Molecular (rRT-PCR)
EUA Issued: March 21, 2020

In a March statement, the FDA touted this as the first point-of-care COVID-19 test to receive an EUA. The company estimates the detection time as approximately 45 minutes. It is designed for use with Cepheid’s GeneXpert Dx diagnostic software and GeneXpert Infinity systems, which have nearly 5,000 US installations, according to a Cepheid statement.

Hologic, Inc.

Test: Aptima SARS-CoV-2 assay
Type: Molecular (Dual Kinetic Assay)
EUA Issued: May 14, 2020

This test runs on Hologic’s Panther system, which, according to a Hologic press release, can provide results in about three hours and run more than 1,000 tests per day. The company claims that more than 1,000 Panther systems are installed in US labs, and that it expects to produce an average of one million tests per week.

This was the second Hologic test to receive and EUA. On March 16, the FDA issued an EUA for the Panther Fusion SARS-CoV-2 assay, a PCR test that runs on the Panther Fusion system.

Ortho Clinical Diagnostics

Test: VITROS Total and IgG COVID-19 Antibody Test
Type: ELISA Antibody Test
EUA Issued: April 14, 2020

Ortho’s antibody test is designed for use with its VITROS XT 7600, 3600, 5600, and ECi/ECiQ immunodiagnostic systems, which, the company says are installed in more than 1,000 US labs. The Total Reagent Pack is a qualitative test that detects the presence of all antibodies against SARS-CoV-2.

On April 24, Ortho announced it had received another FDA EUA, this one for its Anti-SARS-CoV-2 IgG test, which detects the presence of IgG antibodies. In a statement, the company said it expects to produce “several million” IgG tests per month.

Roche Diagnostics

Test: cobas SARS-CoV-2
Type: Molecular (rRT-PCR)
EUA Issued: March 12, 2020

This test is designed for use with Roche’s cobas 6800 and 8800 systems. The 6800 can process up to 384 results in an eight-hour shift, Roche says, compared with 1,056 results for the 8800 model. The company says results are available in about 3.5 hours. In a statement, Roche said it planned to ship 400,000 tests per week.

Test: Elecsys Anti-SARS-CoV-2
Type: Electrochemiluminescence immunoassay (ECLIA) Antibody Test
EUA Issued: May 2, 2020

Roche describes this as a qualitative antibody test that can be used on cobas e series immunoassay analyzers. Testing time is 18 minutes. As of May 19, the test was live at more than 20 US labs, “with plans in the next several weeks to increase to more than 200 commercial and hospital lab sites with the ability to perform millions of tests per week,” the company stated in a press release.

It’s likely the FDA will continue to issue emergency-use authorizations as the agency receives more applications from IVD manufacturers.

—Stephen Beale

Related Information:

FDA Approves First Antigen Test for Detecting the Coronavirus

Ex-FDA Chief Calls New Covid-19 Antigen Test a ‘Game-Changer’

Serology-based Tests for COVID-19

Serology Testing Free Webinar

Molecular-based Tests for COVID-19

Current Molecular and Antigen Tests with FDA EUA Status

FDA Emergency Use Authorization (EUA) Information, and List of All Current EUAs

With So Many New COVID-19 Serology Tests Obtaining EUAs from the FDA, How Can Clinical Laboratories Identify Tests That Should Perform Reliably?

As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own

Every day, elected officials at all levels of government call for a huge expansion of COVID-19 serology testing. But, as most clinical laboratory managers and pathologists know, it is a complex undertaking for a lab to select any serological test, validate it, then run it daily in support of patient care, and have confidence that the results are accurate and reproducible.

Clinical laboratories across the United States understand the volume of testing will be in the tens of millions—even hundreds of millions—of COVID-19 serology tests. That is an important financial opportunity because it gives clinical labs the opportunity to generate some cash flow to offset the 60% decline in daily routine specimens they have experienced since most states enacted shelter-in-place orders in early March.

But this big opportunity to serve physicians and patients with COVID-19 serology testing also comes with equally big risks. There are three major risks a COVID-19 serology testing program that clinical labs must successfully address, otherwise the consequences can be devastating.

Three Major Serology Testing Risks for Clinical Laboratories

Risk one comes during the time when medical laboratories shop for COVID-19 serology tests. As of this writing, about 20 such tests have an emergency use authorization (EUA) with the Food and Drug Administration (FDA) and more are expected to obtain an EUA. As is true with everything in life, not all of these tests will perform equally. The risk to the lab is that it purchases a COVID-19 assay that later proves to be unreliable, despite the lab’s rigorous validation process.

Risk two derives from the fact that new diagnostic methods are being incorporated into the serology tests that companies are submitting to the FDA for an EUA. Although the data submitted to the FDA may indicate acceptable performance to the federal agency, in actual clinical use many unexpected or unknown factors could be recognized which lower confidence that the new method utilized by this particular assay is producing accurate results. That risk would only be recognized downstream from validation and the lab would find itself dealing with unhappy physicians, patients, and employers (who were using the test to check the health of their employees).

Risk three is supply chain risk. Will the manufacturer of the COVID-19 serology test be capable of supplying all of its clinical lab customers with adequate supplies to meet each lab’s demand for this testing? New manufacturers have an unknown track record in their ability to supply their lab customers. But even the largest in vitro diagnostics (IVD) manufacturers may need to ration kits, reagents, and other consumables to the large number of medical laboratories they serve. This happened with the rapid molecular tests for COVID-19. Community laboratories capable of performing these tests could not obtain adequate supplies to serve their client physicians.

Millions Lost on Faulty COVID-19 Serology Test Kits

If there is a fourth major risk to clinical labs performing COVID-19 serology tests for physicians, patients, and employers (who are screening employees in their workplace) it is the negative publicity that can result if a lab’s choice of a COVID-19 serology test ends up generating inaccurate or unreliable test results.

This is a risk not to be ignored. Dark Daily has already written about the global headlines that resulted after both Spain and the United Kingdom spent tens of millions of dollars on COVID-19 serology kits produced by Chinese companies, only to find out that these tests failed to perform at acceptable levels of accuracy. (See, “Chinese Firm to Replace Clinical Laboratory Test Kits After Spanish Health Authorities Report Tests from China’s Shenzen Bioeasy Were Only 30% Accurate,” April 3, 2020.)

The most recent example is here in the United States. On March 27, Abbott Laboratories announced that the FDA had issued an EUA for its Abbott ID NOW platform and its point-of-care rapid molecular test for COVID-19 that could produce results in less than 15 minutes. This made national news and was hailed regularly during the daily White House COVID-19 Task Force briefings.

But then, last week, the ID NOW COVID-19 test was again in the national headlines. For example, CNN published a story on May 14 with the headline, “Abbott’s Fast COVID-19 Test May Miss Too Many Cases, NYU Study Finds,” in which CNN wrote that authors of a study published on bioRxiv titled, “Performance of Abbott ID NOW Rapid SARS-CoV-2 NAAT,” from NYU Langone Health and Grossman School of Medicine in New York City said “the Abbott test was so inaccurate that it was ‘unacceptable’ for use with their patients.” Concerns centered around the true rate of false negatives. Abbott has robustly defended its test and more studies will be forthcoming.

What is important with the examples of Spain, United Kingdom, and a major IVD manufacturer is that news outlets are ready to pounce on any evidence that COVID-19 tests are returning inaccurate or unreliable results. This is a source of risk which every clinical laboratory wants to avoid.

How Clinical Laboratories Can Minimize Risk When Buying COVID-19 Serology Tests

Recognizing that clinical laboratories have been left to their own devices when selecting which of the 20 or so COVID-19 serology tests with EUAs they should buy, validate, and offer to their clients, The Dark Report and its new COVID-19 STAT Intelligence Briefings will present a free webinar titled “Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests,” on Thursday, May 21 at 1 PM Eastern Daylight Time.

This webinar will be conducted by James O. Westgard, PhD, Founder of Westgard QC, and Sten Westgard, Director of Client Services and Technology for Westgard QC.

Sten Westgard of Westgard QC at the podium at LAB QUALITY CONFAB meeting held by THE DARK REPORT.
During their upcoming webinar, James Westgard, PhD (above), and Sten Westgard of Westgard QC will address how clinical laboratory leaders can evaluate different serology COVID-19 tests by: understanding the testing architecture and intended medical use of COVID-19 testing, taking inventory of lab resources; navigating EUA, LDT, and non-EUA regulatory approval; assessing the expected performance of test methods; understanding the critical performance characteristics for COVID-19 testing; and much more. (Photo copyright: Dark Daily.)

This is an exceptional opportunity to gain an inside perspective of how your lab can address the three major risks identified above when selecting a COVID-19 serology test for use in patient care. You’ll gain essential insights about how to assess the public data on tests with an EUA.

This webinar presentation will also discuss how your lab should view all of its COVID-19 testing as a single program. That’s because your lab may test the same patient with a rapid molecular test, then later do serology tests in the days after the patient may have cleared the infection.

Register now for this critical educational opportunity by clicking here or by entering this URL in your web browser (https://www.darkdaily.com/webinar/quality-issues-your-clinical-laboratory-should-know-before-you-buy-or-select-covid-19-serology-tests/).

—Michael McBride

Related Information:

Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests, featuring James Westgard, PhD

Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes

FDA EUA: Abbott ID NOW COVID-19 Test

NYU Study: Performance of Abbott ID NOW Rapid SARS-CoV-2 NAAT

Abbott’s Fast Covid-19 Test May Miss Too Many Cases, NYU Study Finds

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse.

25th Annual Executive War College July 14-15, 2020 Hyatt Regency, New Orleans, LA

14th Annual Lab Quality Confab November 17-18, 2020

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse

Limited availability of COVID-19 clinical lab tests is major topic at federal briefings and news stories, yet many of nation’s labs are laying off staff and at point of closing

Cash flow at the nation’s clinical laboratories has crashed, with revenues down by more than $5 billion since early March. This is the biggest financial disaster for the nation’s clinical laboratory industry in its 100-year history and it couldn’t come at a worse time for the American public and the US healthcare system.

At the precise moment when the nation needs clinical laboratories to begin performing millions of tests for SARS-CoV-2, the coronavirus that causes the COVID-19 illness, those same labs are watching their cash flow collapse.

Data from multiple sources gathered by The Dark Report, sister publication of Dark Daily, confirm that—beginning in early March and continuing through last week—clinical laboratories in the United States saw incoming flows of routine specimens decline by between 50% and 60%. During this same time, lab revenue fell by similar amounts.

Clinical Lab Industry Currently Losing $800 to $900 Million Weekly

To give this decline context, the healthcare system spends about $80 billion annually on medical laboratory testing. Thus, labs across the US generated about $1.5 billion in revenue each week during 2019 and into 2020. By April 5, the decline in routine lab specimen volumes reached 55% to 60%. Since then, the clinical lab industry now loses between $800 million and $900 million each week. Total revenue loss from previous levels is already estimated to be $5.2 billion, and it is growing by an additional $800 million to $900 million every week that patients stay away from hospitals and physicians’ offices.

In the eight weeks since the COVID-19 pandemic caused patients to cease coming to hospitals and visiting their doctors, incoming routine specimens and revenue fell by 60%, causing cumulative lost routine revenue of $5.2 billion for the clinical laboratory industry in the United States. Each week that the existing shelter-in-place directives are effective, labs lose another $800 million to $900 million. The Dark Report based these estimates on data provided by multiple companies working with lab billing/claims, middleware analytical solutions, and customer relationship management (CRM) and electronic health record (EHR) products. (Chart copyright: The Dark Intelligence Group, Inc.)

The recent dire financial condition of labs small and large has gone unremarked by federal healthcare officials at the daily White House COVID-19 Task Force briefings. National news sources have yet to report on this development and its implications for successfully expanding the availability and numbers of COVID-19 tests in response to the pandemic.

The rapid and deep decline in specimens and revenue is not limited to clinical laboratories. Biopsy cases referred to anatomic pathology groups have declined by 50% to 60%. Some subspecialty pathology labs saw case referrals drop by 80% or more.

The nation’s two biggest clinical laboratory companies confirmed similar declines in their normal daily flow of routine specimens. Both companies recently reported first-quarter earnings (which included the month of March).

Quest Diagnostics, LabCorp Each Disclose Volume Declines of 50% to 60%

During its Q1 2020 earnings conference call, Chairman, President, and CEO of Quest Diagnostics (NYSE:DGX), Steve Rusckowski, stated, “In April, volume declines continue to intensify as we are seeing signs that volume declines are bottoming out at around 50% to 60%.”

The drop-off in routine lab test referrals was the similar at LabCorp (NYSE:LH). “In our diagnostics business, at the end of the quarter, we experienced reductions in demand for testing of 50% to 55% versus the company’s normal daily levels,” explained Glenn Eisenberg, Executive Vice President and CFO during LabCorp’s Q1 2020 earnings call. “This reduction in demand impacted testing volume broadly but was more heavily weighted towards routine procedures.”

Interviews with independent clinical lab owners and the administrative directors of hospital and health system labs further confirm this rapid and dramatic decline in the number of routine specimens arriving in their labs. Fewer specimens mean fewer claims, which means less revenue to laboratories.

Two Different Financial Futures for ‘Have’ Labs and ‘Have Not’ Labs

What happens next to the clinical laboratory industry in the United States—and to its ability to continue ramping up the availability of adequate numbers of COVID-19 tests in major cities, small towns, and rural areas—will be a story of “haves” and “have nots.”

The “haves” are clinical labs that have access to money. These are publicly-traded lab companies, academic medical center labs, and the sophisticated labs of health networks that operate multiple hospitals. In each case, these organizations have capital reserves and access to loans that will probably enable them to sustain COVID-19 lab testing services at the large volumes required to respond to the pandemic.

Examples of “have” labs would range from public lab companies like LabCorp, Quest Diagnostics, Sonic Healthcare USA, and BioReference Laboratories to the labs of healthcare organizations such as Mayo Clinic, Cleveland Clinic, Geisinger Health, Advocate Aurora Health, and ARUP Laboratories.

The “have nots” will be:

  • clinical laboratories that are privately-owned;
  • clinical labs operated by community hospitals and rural hospitals that were not financially robust before the onset of the pandemic; and,
  • specialty lab companies that perform a specific number of proprietary diagnostic tests (and for which demand has collapsed as patients stopped seeing their doctors).

Medicare Led Payers in the ‘Lab Test Price Race to the Bottom’

Prior to the onset of the SARS-CoV-2 pandemic, the finances of the “have-not” labs were already shaky, with many on the verge of filing bankruptcy, closing, or selling to a bigger lab company. Much blame for the deteriorating finances at a large proportion of community lab companies, community hospital labs, and rural hospital labs can be attributed to the deep, multi-year price cuts to the Medicare Part B clinical laboratory fee schedule as mandated by the Protecting Access to Medicare Act of 2014 (PAMA).

Medicare’s multi-year cuts to lab test prices were immediately copied by most state Medicaid programs. During this period, private payers followed Medicare’s lead and enacted their own deep cuts to the prices they paid labs for both routine tests and molecular/genetic tests.

That is why—when the pandemic intensified in early March—the 50% to 60% drop in specimens and revenue that hit these labs starved them of essential cash flow. When polled, the owners and directors of these labs acknowledge layoffs of the majority of their staff in all departments. They also reported substantial delays—both in submitted lab test claims and in getting payment for those claims—because claims-processing departments at the labs and private health insurers are understaffed due to shelter-in-place directives.

COVID-19 Test Revenue Helps Only Labs Performing Those Tests

Revenue from COVID-19 testing is helping certain labs offset the revenue loss from fewer routine specimens. XIFIN, Inc., a San Diego company that provides revenue cycle management (RCM) services for clinical laboratories and pathology groups, analyzed the lab test claims for COVID-19 rapid molecular tests. It determined that labs performing these tests are generating enough revenue from these test claims to equal about 20% of their pre-pandemic revenue.

The chart above was prepared by XIFIN, Inc., of San Diego and is based on the changes XIFIN observed in the volume of routine clinical laboratory test claims generated by client labs on a weekly basis. In the first two months of 2020, routine lab test claims ran at expected levels until the first week of March. During the rest of March, routine lab test claims declined by 60%. During April, incoming routine lab test claims remained 55% to 60% below pre-pandemic levels. The shaded area shows the number of COVID-19 test claims coming into clinical labs. XIFIN says COVID-19 test claims make up about 20% of the decline in routine test specimens for those labs performing COVID-19 tests. The Dark Report estimates that the clinical laboratory industry has lost $800 million to $900 million in routine test revenue each week since March 23. Weekly revenue losses will continue at this rate until patients begin visiting their physicians and hospitals again perform elective services.  (Chart copyright: XIFIN, Inc.)

Many CLIA-certified community laboratories and hospital labs have the diagnostic instruments and experience to perform rapid molecular tests for COVID-19. But when contacted, they tell us that their suppliers do not ship them even minimal quantities of the COVID-19 kits, the reagents, and the consumables. Thus, they cannot meet the needs of their client physicians. Instead, they watch as these physicians refer COVID-19 tests to the nation’s largest labs. The supply shortage prevents these smaller labs from doing larger numbers of COVID-19 test for the patients in the communities they serve. It also prevents them from earning the revenues from COVID-19 testing that currently helps the nation’s “have” labs offset the decline in revenue from routine testing.

Congress, national healthcare policymakers, and state governors need to immediately address this situation. Each week that passes during the COVID-19 pandemic and the shelter-in-place directives drains another $800 million to $900 million in revenue from routine lab testing that previously flowed into the nation’s clinical laboratories.

‘Have-not’ Clinical Labs in Small Towns Will Quietly Shrink and Disappear

Without timely intervention and financial support, the nation’s network of ‘have not’ labs, which have so capably served towns away from big metropolitan centers and rural areas, will quietly begin shrinking. One at a time, labs in small towns will close or sell. Local lab facilities will be shuttered and specimens from small-town patients will be transported to big labs hundreds or thousands of miles away.

It is also true that the financial disaster besetting the nation’s clinical laboratory industry will have comparable dramatic consequences for the in vitro diagnostics (IVD) manufacturers that sell them automation, analyzers, reagents, and other supplies. Since early March, IVD manufacturers watched as the pandemic caused orders for new instruments to collapse. During these same weeks, their clinical lab customers ceased ordering routine test kits at pre-pandemic levels. Dark Daily will cover the challenges confronting the IVD and other diagnostics industries in future e-briefings.

Announcing Free COVID-19 STAT Intelligence Briefings for Clinical Labs

With the COVID-19 pandemic creating chaos in nearly every aspect of healthcare, business, and society, clinical labs and their suppliers need timely intelligence and analysis about the innovations and successes achieved by their peers. This week, Dark Daily and The Dark Report are launching COVID-19 STAT Intelligence Briefings (Copy and paste this URL into your browser: https://www.covid19briefings.com). This comprehensive service is free and will cover four basic areas of needs for clinical laboratories as they ramp up COVID-19 testing:

  • Daily and weekly COVID-19 testing dashboards to guide every lab’s short-term planning;
  • Proven steps for labs to introduce and validate COVID-19 tests (both rapid molecular tests and serology tests);
  • Getting paid for COVID-19 testing to ensure every lab’s financial stability and clinical quality; and
  • Legal and regulatory updates for labs doing COVID19 tests to ensure full compliance.

Also, to help clinical laboratory leaders deal with the coming wave of COVID-19 serology tests, we are producing a free webinar led by James O. Westgard, PhD, FACB, and Sten Westgard, Director of Client Services and Technology, of Westgard QC, Inc.

Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests,” will take place on Thursday, May 21, at 1:00 PM EDT. For details and to register, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/quality-issues-your-clinical-laboratory-should-know-before-you-buy-or-select-covid-19-serology-tests.

Each week that the SARS-CoV-2 pandemic continues, and strict shelter-in-place directives are in place, the clinical laboratory industry loses another almost $900 million in revenue from lower volumes of routine testing. No industry can survive when its incoming revenue collapses by 50% to 60% for sustained periods of time.

Will Congress Recognize the Need for a Financial Rescue of ‘Have-not’ Labs?

Thus, it is incumbent on Congress, elected officials, and healthcare policymakers to recognize the financial consequences of the pandemic to the nation’s clinical laboratories. That is particularly true of the ‘have-not’ clinical labs. They do not have the same access to decisionmakers in government as billion-dollar lab companies.

And yet, these labs located in small communities and rural areas often are the only local labs that can do STAT testing in a couple of hours, and where clinical pathologists are personally familiar with local physicians and patients.

These “have-not” labs are vital healthcare resources. They should receive the help they need to get through this unprecedented crisis that is the COVID-19 pandemic.

—Robert L. Michel
Editor-in-Chief

Related Information:

Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests

COVID-19 STAT Intelligence Service: Resources and Help for Labs During the SARS-CoV-2 Pandemic

COVID-19 Disruptions of Supply Chains Are One More Challenge for Clinical Laboratories to Bring Value to Hospitals and Healthcare Networks

FDA Issues First Approval for At-Home COVID-19 Test to LabCorp’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public

Serological Antibody Tests a ‘Potential Game Changer’ and Next Phase in Efforts to Combat the Spread of COVID-19 That Give Clinical Laboratories an Essential Role

A Tale of Two Countries: As the US Ramps Up Medical Laboratory Tests for COVID-19, the United Kingdom Falls Short

Medical Laboratories Need to Prepare as Public Health Officials Deal with Latest Coronavirus Outbreak

Antibody Tests Were Supposed to Help Guide Reopening Plans. They’ve Brought More Confusion than Clarity

Is the Coronavirus Antibody Test a Magic Bullet—Or False Hope?

A Tale of Two Countries: As the US Ramps Up Medical Laboratory Tests for COVID-19, the United Kingdom Falls Short

Media reports in the United Kingdom cite bad timing and centralization of public health laboratories as reasons the UK is struggling to meet testing goals

Clinical pathologists and medical laboratories in UK and the US function within radically different healthcare systems. However, both countries faced similar problems deploying widespread diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. And the differences between America’s private healthcare system and the UK’s government-run, single-payer system are exacerbating the UK’s difficulties expanding coronavirus testing to its citizens.

The Dark Daily reported in March that a manufacturing snafu had delayed distribution of a CDC-developed diagnostic test to public health laboratories. This meant virtually all testing had to be performed at the CDC, which further slowed testing. Only later that month was the US able to significantly ramp up its testing capacity, according to data from the COVID Tracking Project.

However, the UK has fared even worse, trailing Germany, the US, and other countries, according to reports in Buzzfeed and other media outlets. On March 11, the UK government established a goal of administering 10,000 COVID-19 tests per day by late March, but fell far short of that mark, The Guardian reported. The UK government now aims to increase this to 25,000 tests per day by late April.

This compares with about 70,000 COVID-19 tests per day in Germany, the Guardian reported, and about 130,000 per day in the US (between March 26 and April 14), according to the COVID Tracking Project.

“Ministers need to explain why the NHS [National Health Service] is not testing to capacity, why we are falling behind other countries, and what measures they will put in place to address this situation as a matter of urgency,” MP Keir Starmer (above) said in Parliament in late March, The Guardian reported. (Photo copyright: The Guardian.)

What’s Behind the UK’s Lackluster COVID-19 Testing Response

In January, when the outbreak first hit, Public Health England (PHE) “began a strict program of contact tracing and testing potential cases,” Buzzfeed reported. But due to limited medical laboratory capacity and low supplies of COVID-19 test kits, the government changed course and de-emphasized testing, instead focusing on increased ICU and ventilator capacity. (Scotland, Wales, and Northern Ireland each have separate public health agencies and national health services.)

Later, when the need for more COVID-19 testing became apparent, UK pathology laboratories had to contend with global shortages of testing kits and chemicals, The Guardian reported. At present, COVID-19 testing is limited to healthcare workers and patients displaying symptoms of pneumonia, acute respiratory distress syndrome, or influenza-like illness, PHE stated in “COVID-19: Investigation and Initial Clinical Management of Possible Cases” guidance.

Another factor that has limited widespread COVID-19 testing is the country’s highly-centralized system of public health laboratories, Buzzfeed reported. “This has limited its ability to scale and process results at the same speed as other countries, despite its efforts to ramp up capacity,” Buzzfeed reported. Public Health England, which initially performed COVID-19 testing at one lab, has expanded to 12 labs. NHS laboratories also are testing for the SARS-CoV-2 coronavirus, PHE stated in “COVID-19: How to Arrange Laboratory Testing” guidance.

Sharon Peacock, PhD, PHE’s National Infection Service Interim Director, Professor of Public Health and Microbiology at the University of Cambridge, and honorary consultant microbiologist at the Cambridge clinical and public health laboratory based at Addenbrookes Hospital, defended this approach at a March hearing of the Science and Technology Committee (Commons) in Parliament.

“Laboratories in this country have largely been merged, so we have a smaller number of larger [medical] laboratories,” she said. “The alternative is to have a single large testing site. From my perspective, it is more efficient to have a bigger testing site than dissipating our efforts into a lot of laboratories around the country.”

Writing in The Guardian, Paul Hunter, MB ChB MD, a microbiologist and Professor of Medicine at University of East Anglia, cites historic factors behind the testing issue. The public health labs, he explained, were established in 1946 as part of the National Health Service. At the time, they were part of the country’s defense against bacteriological warfare. They became part of the UK’s Health Protection Agency (now PHE) in 2003. “Many of the laboratories in the old network were shut down, taken over by local hospitals or merged into a smaller number of regional laboratories,” he wrote.

US Facing Different Clinical Laboratory Testing Problems

Meanwhile, a few medical laboratories in the US are now contending with a different problem: Unused testing capacity, Nature reported. For example, the Broad Institute of MIT and Harvard in Cambridge, Mass., can run up to 2,000 tests per day, “but we aren’t doing that many,” Stacey Gabriel, PhD, a human geneticist and Senior Director of the Genomics Platform at the Broad Institute, told Nature. Factors include supply shortages and incompatibility between electronic health record (EHR) systems at hospitals and academic labs, Nature reported.

Politico cited the CDC’s narrow testing criteria, and a lack of supplies for collecting and analyzing patient samples—such as swabs and personal protective equipment—as reasons for the slowdown in testing at some clinical laboratories in the US.

Challenges Deploying Antibody Tests in UK

The UK has also had problems deploying serology tests designed to detect whether people have developed antibodies against the virus. In late March, Peacock told members of Parliament that at-home test kits for COVID-19 would be available to the public through Amazon and retail pharmacy chains, the Independent reported. And, Politico reported that the government had ordered 3.5 million at-home test kits for COVID-19.

However, researchers at the University of Oxford who had been charged with validating the accuracy of the kits, reported on April 5 that the tests had not performed well and did not meet criteria established by the UK Medicines and Healthcare products Regulatory Agency (MHRA). “We see many false negatives (tests where no antibody is detected despite the fact we know it is there), and we also see false positives,” wrote Professor Sir John Bell, GBE, FRS, Professor of Medicine at the university, in a blog post. No test [for COVID-19], he wrote, “has been acclaimed by health authorities as having the necessary characteristics for screening people accurately for protective immunity.”

He added that it would be “at least a month” before suppliers could develop an acceptable COVID-19 test.

Meanwhile, in the US, on April 1 the FDA issued an Emergency Use Authorization (EUA) for the qSARS-CoV-2 IgG/IgM Rapid Test developed by Cellex Inc. in N.C., the Washington Times reported. Cellex reported that its test had a 93.75% positive agreement with a PCR (polymerase chain reaction) test and a 96.4% negative agreement with samples collected before September 2019.

In the United States, the Cellex COVID-19 test is intended for use by medical laboratories. As well, many research sites, academic medical centers, clinical laboratories, and in vitro diagnostics (IVD) companies in the US are working to develop and validate serological tests for COVID-19.

Within weeks, it is expected that a growing number of such tests will qualify for a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and become available for use in patient care.

—Stephen Beale

Related Information:

Why the UK Failed to Get Coronavirus Testing Up to Speed

Even the US Is Doing More Coronavirus Tests than the UK. Here Are the Reasons Why

Fall in Covid-19 Tests Putting Lives at Risk, Critics Claim

UK Ministers Accused of Overstating Scale of Coronavirus Testing

Coronavirus: Government Sets Target for 100,000 Tests Per Day by End of Month

Coronavirus Test: UK To Make 15-Minute At-Home Kits Available ‘Within Days’

Coronavirus: Can I Get a Home Testing Kit and What Is an Antibody Test?

Covid-19 Testing in the UK: Unpicking the Lockdown

Current COVID-19 Antibody Tests Aren’t Accurate Enough for Mass Screening, Say Oxford Researchers

Thousands of Coronavirus Tests Are Going Unused in US Labs

Exclusive: The Strongest Evidence Yet That America Is Botching Coronavirus Testing

Coronavirus Testing Hits Dramatic Slowdown in US

Coronavirus Testing Is Starting to Get Better—But It Has a Long Way to Go

Was It Flu or the Coronavirus? FDA Authorizes First COVID-19 Antibody Test

Medical Laboratories Need to Prepare as Public Health Officials Deal with Latest Coronavirus Outbreak

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