News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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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

Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests

In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests

Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics which claim to detect the actual presence of the coronavirus itself.

“Diagnostic tests, typically involving a nasopharyngeal swab, can be inaccurate in two ways,” said Steven Woloshin, MD, MS, in a news release announcing a new report that “examines challenges and implications of false-negative COVID-19 tests.” Woloshin is an internist, a professor at Dartmouth Institute, and co-director of the Geisel School of Medicine at Dartmouth.

“A false-positive result mistakenly labels a person infected, with consequences including unnecessary quarantine and contact tracing,” he stated in the news release. “False-negative results are far more consequential, because infected persons who might be asymptomatic may not be isolated and can infect others.”

Woloshin led a team of Dartmouth researchers who analyzed two studies from Wuhan, China, and a literature review by researchers in Europe and South America that indicated diagnostic tests for COVID-19 are frequently generating false negatives. The team published their results in the June 5 New England Journal of Medicine (NEJM).

For example, one research team in Wuhan collected samples from 213 hospitalized COVID-19 patients and found that an approved RT-PCR test produced false negatives in 11% of sputum samples, 27% of nasal samples, and 40% of throat samples. Their research was published on the medRxiv preprint server and has not been peer-reviewed.

The literature review Woloshin’s team studied was also published on medRxiv, titled, “False-Negative Results of Initial Rt-PCR Assays for COVID-19: A Systematic Review.” It indicated that the rate of false negatives could be as high as 29%. The authors of the review looked at five studies that had enrolled a total of 957 patients. “The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability,” they wrote. “Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection.”

Another literature review, published in the Annals of Internal Medicine, titled, “Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction–Based SARS-CoV-2 Tests by Time Since Exposure,” estimated the probability of false negatives in RT-PCR tests at varying intervals from the time of exposure and symptom onset. For example, the authors found that the median false-negative rate was 38% if a test was performed on the day of symptom onset, versus 20% three days after onset. Their analysis was based on seven studies, five of which were peer-reviewed, with a total of 1330 test samples.

Doctors also are seeing anecdotal evidence of false negatives. For example, clinicians at UC San Diego Health medical center treated a patient with obvious symptoms of COVID-19, but two tests performed on throat samples were negative. However, a third test, using a sample from a bronchial wash, identified the virus, reported Medscape.

The lesson for clinicians is that they can’t rely solely on test results but must also consider their own observations of the patient, Joshua Metlay, MD, PhD, of Massachusetts General Hospital told Medscape.

Sensitivity and Specificity of COVID-19 Clinical Laboratory Tests

The key measures of test accuracy are sensitivity, which refers to the ability to detect the presence of the virus, and specificity, the ability to determine that the targeted pathogen is not present. “So, a sensitive test is less likely to provide a false-negative result and a specific test is less likely to provide a false-positive result,” wrote Kirsten Meek, PhD, medical writer and editor, in an article for ARUP Laboratories.

“Analytic” sensitivity and specificity “represent the accuracy of a test under ideal conditions in which specimens have been collected from patients with either high viral loads or a complete absence of exposure,” she wrote. However, “sensitivity and specificity under real-world conditions, in which patients are more variable and specimen collection may not be ideal, can often be lower than reported numbers.”

In a statement defending its ID Now molecular point-of-care test, which came under scrutiny during a study of COVID-19 molecular tests by NYU Langone Health, Northwell Health, and Cleveland Clinic, according to MedTech Dive, Abbott Laboratories blamed improper sample collection and handling for highly-publicized false negatives produced by its rapid test. An FDA issued alert about the test on May 14 noted that Abbott had agreed to conduct post-market studies to identify the cause of the false negatives and suggest remedial actions.

Issues with Emergency Use Authorizations

In their NEJM analysis, Woloshin et al point to issues with the FDA’s process for issuing Emergency Use Authorizations (EUAs). For example, they noted variations in how manufacturers are conducting clinical evaluations to determine test performance. “The FDA prefers the use of ‘natural clinical specimens’ but has permitted the use of ‘contrived specimens’ produced by adding viral RNA or inactivated virus to leftover clinical material,” they wrote.

When evaluating clinical performance, manufacturers ordinarily conduct an index test of patients and compare the results with reference-standard test, according to the Dartmouth researchers. For people showing symptoms, the reference standard should be a clinical diagnosis performed by an independent adjudication panel. However, they wrote, “it is unclear whether the sensitivity of any FDA-authorized commercial test has been assessed in this way.” Additionally, a reference standard for determining sensitivity in asymptomatic people “is an unsolved problem that needs urgent attention to increase confidence in test results for contact-tracing or screening purposes.”

Stephen Rawlings, MD, PhD
“To truly determine false negatives, you need a gold standard test, which is essentially as close to perfect as we can get,” Stephen Rawlings, MD, PhD, (above), a resident physician of internal medicine and infectious diseases fellow at UC San Diego’s Center for AIDS Research (CFAR), who has been working on SARS-CoV-2 test validation since March. “But there just isn’t one yet for coronavirus,” he told Medscape. (Photo copyright: University of California, San Diego.)

In a perspective for Mayo Clinic Proceedings, Colin P. West, MD, PhD; Victor M. Montori, MD, MSc; and Priya Sampathkumar, MD, offered four recommendations for addressing concerns about testing accuracy:

  • Continued adherence to current measures, such as physical distancing and surface disinfection.
  • Development of highly sensitive and specific tests or combinations of tests to minimize the risk of false-negative results and ongoing transmission based on a false sense of security.
  • Improved RT-PCR tests and serological assays.
  • Development and communication of clear risk-stratified protocols for management of negative COVID-19 test results.

“These protocols must evolve as diagnostic test, transmission, and outcome statistics become more available,” they wrote.

Meanwhile, clinical laboratories remain somewhat on their own at selecting which COVID-19 molecular and serology tests they want to purchase and run in their labs. Complicating such decisions is the fact that many of the nation’s most reputable in vitro diagnostics manufacturers cannot produce enough of their COVID-19 tests to meet demand.

Consequently, when looking to purchase tests for SARS-CoV-2, smaller medical laboratory organizations find themselves evaluating COVID-19 kits developed by little-known or even brand-new companies.

—Stephen Beale

Related Information:

New Report Examines Challenges and Implications of False-Negative COVID-19 Tests

Questions about COVID-19 Test Accuracy Raised Across the Testing Spectrum

COVID-19 Test Results: Don’t Discount Clinical Intuition

FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

EUA Authorized Serology Test Performance

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

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

Understanding Medical Tests: Sensitivity, Specificity, and Positive Predictive Value

Webinar Part 1: Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests

Webinar Part 2: Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests, featuring James Westgard, PhD

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

New Insertable Cardiac Monitor Released by Abbott Laboratories Enables Patients to Share Collected Data with Anatomic Pathologists and Clinical Laboratories Through Bluetooth Enable Smartphones

Here is another example of how the diagnostic technologies used by anatomic pathology and clinical laboratories are evolving toward minute devices that deliver data wirelessly to electronic health records and healthcare databases for access by physicians and lab professionals

Anatomic pathologists and clinical laboratory managers keeping track of new implantable patient monitoring devices should find Abbott Laboratories’ (Abbott) recent technology release of great interest.

It’s an insertable cardiac monitor (ICM), also known as an implantable loop recorder, called Confirm Rx that, once implanted, can continuously monitor a patient’s heart rate and, using Bluetooth wireless technology, transmit collected data to physicians via a smartphone app. Abbott claims it is the “world’s first smartphone-compatible ICM.”

The laboratory’s website states, “The Confirm Rx ICM offers convenient, connected, and continuous monitoring for insight into your patients’ conditions and symptoms, including syncope, palpitations, and [atrial fibrillation] before or after ablation therapy and cryptogenic stroke—with fewer interruptions to their daily lives.”

Healthcare providers can implant Confirm Rx underneath the skin of a patient’s chest in just a few minutes using a simple insertion tool. The monitoring device is about the size of a small paper clip and has a two-year battery life. It provides physicians and their patients with an innovative way to identify and monitor abnormal heart rhythms or cardiac arrhythmias.

Transmitting ICM Data Using Smartphone App

Data collected by the Confirm Rx can be transmitted to a healthcare professional using the myMerlin for Confirm Rx smartphone app, developed by St. Jude Medical, which is now Abbott Laboratories (NYSE:ABT). No home-based transmitter, handheld activator, or additional equipment is required. However, individuals who use the Confirm Rx need to keep their smartphones within five feet of their bodies to ensure a continuous connection.

“Confirm Rx shows what we can do with cutting edge communication technology and the most advanced medical devices that provide new opportunities to improve patient care,” stated Avi Fischer, MD, Divisional VP Medical Affairs, and Medical Director for Cardiac Rhythm Management at Abbott, in a news release.

“By offering a device that uses Bluetooth wireless technology from the patient’s smartphone, we can help physicians easily and remotely diagnose potentially dangerous abnormal heart beats without requiring the patient to use a separate or cumbersome recording device,” Fischer concluded.

The myMerlin mobile app transmits its data to the Merlin.net Patient Care Network, where doctors and patients can simultaneously track symptoms, synchronize personal data, and view a transmission history.

“Prior to the evolution of this technology, the ability to monitor patients was really short-lived. But this allows the monitoring to continue and allows the patient to continue to live their lives unhindered,” noted Sean C. Beinart, MD, Cardiologist and Medical Director, Cardiovascular Research Washington Adventist Hospital, in an Abbott product release.

Sean-Beinart-MD-Abbott-Laboratories-Confirm-RX

“Whenever you’re dealing with rhythm problems in the heart, being able to identify risk can sometimes mean the difference between life and death. The key is finding out what happened: What’s the cause of your symptoms?” Sean C. Beinart, MD (above), FACC, FHRS, a Cardiologist and Medical Director, Cardiovascular Research Washington Adventist Hospital, stated in an Abbott Laboratories video. Click on this link to watch the video. (Caption and video copyright: Abbott Laboratories.)

Peace of Mind through Technology

According to Abbott’s website, up to 7.1 million people in the United States are living with irregular heartbeats. The stroke risk for these individuals is five times higher than the risk for those without arrhythmias. When properly diagnosed, the condition is highly treatable.

“The stakes are very high,” Beinart stressed. “What the Confirm Rx does is it gives both me and my patient peace of mind that we’ve got them covered.”

Abbott obtained the Confirm Rx device when it acquired St. Jude Medical last year. The US Food and Drug Administration (FDA) approved the device in October of 2017. The first implantation of the Confirm Rx device took place in November.

The feedback received from users regarding the Confirm Rx has been positive and has helped increase Abbott’s electrophysiology sales by 16% during the last quarter of 2017, Fischer told CNBC.

“The types of patients have varied from younger to older, and [the devices] are being implanted for a variety of conditions,” Fischer stated. “Sometimes it’s to diagnose or to rule something out.”

As more implantable diagnostic monitoring/reporting devices are brought to the market, it is expected that some will be designed to measure some of the same biomarkers used in the assays performed by clinical laboratories. As that happens, clinical labs will have opportunities to serve medical facilities, physicians, and patients in new and more timely ways.

These implantable diagnostic devices may also give medical laboratories another way to be of value in the collection, storing, analysis, and reporting of the data obtained by the monitors, along with other lab tests doctors may order.

—JP Schlingman

Related Information:

Medicine Is Moving from Implantables to ‘Chipables’

Heart Monitor Links Patients to Doctors Using the One Thing They’re Unlikely to Forget Their Phones

Abbott Launches the First and Only Smartphone Compatible Insertable Cardiac Monitor in the U.S.

Heart Monitoring, Everywhere You Go

Confirm Rx Patient Brochure (PDF)

Helping Medical Laboratories Add Value to Health Systems, Providers, and Payers by Moving from Clinical Lab 1.0 to Clinical Lab 2.0

November workshop to teach Clinical Lab 2.0 to forward-thinkers among clinical laboratories, IVD manufacturers, and lab IT vendors offered many examples where clinical laboratory diagnostics can add value and improve patient outcomes

DATELINE: ALBUQUERQUE, New Mexico—Here in this mile-high city, a special Project Santa Fe Workshop devoted to teaching the principles of Clinical Lab 2.0 attracted an impressive roster of innovators and forward-thinkers in clinical laboratory medicine. In attendance were leaders from a select number of the nation’s first-rank health systems and hospitals, along with executives from In Vitro diagnostics (IVD) manufacturers, lab IT companies, other lab service companies, attendees from the Centers for Disease Control and Prevention, and from institutions in Canada, Germany, Israel, India, and the UK.

Their common goal was to learn more about the emerging clinical and business model for medical laboratories known as “Clinical Lab 2.0.” A key objective of the workshop was to help those lab leaders in attendance develop strategic action plans for their own lab organizations, so as to take advantage of the insights coming from the vast information streams generated by their clinical laboratories. These services would be in support the evolving needs of health systems, hospitals physicians, and health insurers to more effectively provide integrated patient-centered clinical care.

Medical Laboratories Can Use Clinical Lab 2.0 as a Path to Adding Value

Clinical Lab 2.0 is the clinical and business model of the future for medical laboratories, assert the developers of this concept. “Clinical Lab 2.0 describes the attributes needed by all medical laboratories that want to succeed in a healthcare system organized to provide precision medicine, keep people out of hospitals, and where providers—including labs—are reimbursed based on the value they provide,” stated Khosrow Shotorbani, CEO of TriCore Reference Laboratories, one of the organizers of the Project Santa Fe Clinical Lab 2.0 Workshop.

“Clinical Lab 2.0 is the path medical labs will need to follow if they are to continue providing relevant lab testing services and generate the reimbursement necessary for them to maintain a high level of clinical excellence and financial stability going forward,” he added. “This is the next generation of medical laboratory organization and operation.”

Lab 1.0 Was Lab Clinical/Business Model for 50 Years

For more than 50 years, Clinical Lab 1.0 was the model for labs,” noted James Crawford, MD, PhD, Executive Director and Senior Vice President of Laboratory Services at Northwell Health Laboratories and an organizer of the Project Santa Fe Clinical Lab 2.0 Workshop. “Lab 1.0 is transactional, focusing on generating high quality analytical data on specimens received, but without assembling these data into integrative clinical care programs. In the simplest sense, Clinical Lab 1.0 focused on generating ever-greater numbers of specimens to drive down average cost-per-test, while maximizing revenue in a fee-for-service system.

This chart shows the attributes of Clinical Lab 1.0 and compares those to the attributes of Clinical Lab 2.0. Lab 1.0 is transactional and based on increasing test volume to lower costs and maximize fee-for-service revenue. Clinical Lab 2.0 is integrative in ways that add value to lab testing services. (Graphic copyright Project Santa Fe.)

“But fee-for-service payment is going away,” he said. “Increasingly, clinical laboratories will be paid based on the value they provide. This payment can be in the form of bundled reimbursement, as a per-member-per-month payment, or as a share of the budgeted payment made to a health system, an accountable care organization (ACO), or a multispecialty provider network. As these alternative forms of provider payment become dominant, to earn a fair share of reimbursement, all medical laboratories will need a clinical strategy to deliver lab testing services that measurably contribute to improved patient outcomes while reducing the overall cost of care. This requires looking at medical laboratories’ contribution to effective delivery of the full dollar of the healthcare spend, not just the three-cents-on-the-dollar representing laboratory testing.”

Innovators in Clinical Laboratory Industry Identify New Ways to Add Value

There are already a handful of innovative clinical laboratory organizations that have clinical experience in moving past the Lab 1.0 paradigm of reporting an accurate test result within the accepted turnaround time. Leaders within these labs are collaborating with physicians and frontline care givers specifically to help them better utilize lab tests in ways that directly improve the speed and accuracy of the overall diagnostic sequence, as well as achieving therapeutic optimization as rapidly as possible. These collaborations are tracking the improvement in patient outcomes while demonstrating how better use of lab tests can lower the total cost per episode of care.

During the Clinical Lab 2.0 workshop, case studies were presented demonstrating how clinical laboratory leaders are taking the first steps to practice Clinical Lab 2.0 so as to achieve added value with medical laboratory tests. The case studies included:

·       A project to improve diagnosis and treatment of sepsis at Geisinger Health System.

·       A project at Henry Ford Health to collaborate with physicians to more appropriately utilize lab tests and build consensus in support of a new lab test formulary.

·       A multi-hospital initiative at Northwell Health to collaborate with physicians and nurses in the use of creating testing to make earlier, more accurate diagnoses of acute kidney injury during inpatient admissions, and better guide decisions to treat.

·       A partnership involving TriCore Reference Laboratory and certain health insurers in New Mexico where the laboratory—using lab test data (some generated by emergency room testing) and other clinical data—alerts the insurers to women who are pregnant, thus allowing the insurers to provide timely guidance to the women’s care teams with the goal of improving prenatal care.

The Project Santa Fe Clinical Lab 2.0 Workshop convened on November 13-14 in Albuquerque, N.M. A broad spectrum of innovative professionals from the five Project Santa Fe member laboratories (above) were there to teach the lessons learned from their first successful efforts to collaborate with physicians and create added value from medical laboratory diagnostics. Other attendees included progressive lab leaders from several of the nation’s most prominent health systems, along with thought leaders from the IVD, lab software, and lab association sectors. (Photo copyright Project Santa Fe.)

Project Santa Fe Workshop: A Well-Attended Lab ‘Think Tank’

Participants attending the Clinical Lab 2.0 workshop included hospital lab administrators, pathologists, and clinical laboratory industry executives. The importance of this workshop is reflected in the educational grants and financial support provided by leading in vitro diagnostics manufacturers, lab IT companies, and other lab industry vendors. The lab industry vendors included:

·       Abbott Laboratories

·       ARUP Laboratories

·       Beckman Coulter

·       DiaSorin

·       MedSpeed

·       Roche Diagnostics

·       Siemens Healthineers

·       Sysmex

Also providing educational grants and similar support were:

·       American Clinical Laboratory Association

·       CAP Today

·       Centers for Disease Control and Prevention

·       Mayo Medical Laboratories

·       The Dark Report

Project Santa Fe was launched in 2016 by clinical lab leaders from five of the nation’s most respected integrated health systems:

·       TriCore Reference Laboratories;

·       Henry Ford Health;

·       Geisinger Health;

·       Kaiser Permanente Northern California; and,

·       Northwell Health.

Described as a think-tank venture, the organizers are committed to implementing projects that demonstrate how lab tests can be used in ways that add value, and then publish the resulting projects, along with data about improved patient outcomes and reductions in healthcare costs, in peer-reviewed journals. Multi-institutional studies will be required to validate the findings and outcomes from the added-value clinical collaborations initiated at the different medical laboratory organizations participating in Project Santa Fe.

Another primary goal is to share the lessons learned from these innovative projects with other like-minded pathologists, lab administrators, and lab managers. In May, Project Santa Fe organizers led a one-day workshop to teach Clinical Lab 2.0 at the Executive War College on Laboratory and Pathology Management. The workshop in Albuquerque on November 13-14 was the second learning opportunity available to medical laboratory professionals. A November 2018 workshop is planned.

—Robert L. Michel

Related Information:

Project Santa Fe Workshop

Improving American Healthcare through “Clinical Lab 2.0”: A Project Santa Fe Report

Laboratory 2.0: Changing the Conversation

CEO Describes Characteristics of the Clinical Lab 2.0 Model: Five Health System Labs Using Project Santa Fe To Demonstrate Value

Moving to Clinical Lab 2.0: Deliver More Value! Get Paid More Dollars!

Lab Innovators Advocate Need for Clinical Lab 2.0: Lab 1.0 Is the Low-Paid Commodity Lab, While Lab 2.0 Gets Paid More for the Value It Contributes

Using the Laboratory Value Pyramid and Clinical Lab 2.0 to Position Your Lab to Add Value in the Era of Population Health, Precision Medicine, and Value-Based Payment

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