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

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

Hosted by Robert Michel
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Can Consumers Collect Their Own Biological Specimens for Direct-to-Consumer SARS-CoV-2 Tests? FDA Says ‘No’ to Clinical Labs Announcing Such Tests

Following criticism over delays in authorizing medical LDT COVID-19 tests, the FDA swiftly shut down consumer at-home specimen collection schemes

Banning COVID-19 tests that rely on consumers’ collecting their own specimens at home is one example where the federal US Food and Drug Administration (FDA) took remarkably swift action. It’s also interesting to note how some business people—who lack formal training in clinical laboratory medicine—often are ready to seize any opportunity to sell lab tests directly to consumers, regardless of whether such tests are reliable, accurate, medically-necessary, and reasonably priced.

Last month, in the midst of this novel coronavirus pandemic, the attempt by a handful of direct-to-consumer (DTC) lab companies to sell COVID-19 tests to customers was speedily stopped by the FDA less than 10 days after the agency became aware of the DTC testing schemes. This all happened off the radar screen of most pathologists and clinical laboratory administrators, whose full-time attention has been on serving the urgent needs of their parent hospitals, referring physicians, and patients.

Within days of each other, several direct-to-consumer lab testing companies announced plans to offer COVID-19 tests to consumers. A common feature of these offerings was that each DTC company would send a collection kit to the consumer, who would collect his or her specimen at home. The kit would then be sent to one of the DTC company’s CLIA-certified laboratories, where the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) test would be performed.

Those DTC companies were:

A flurry of press releases and news interviews about how consumers could order and pay for their own COVID-19 test, collect the specimen at home, and have a Clinical Laboratory Improvement Amendments (CLIA)-certified lab perform the test quickly caught the attention of the FDA. Federal officials took immediate action, or close to it.

On March 20, the FDA issued a warning to healthcare consumers to beware of “unauthorized fraudulent COVID-19 test kits.” On the same day, the FDA announced updated guidance on its website pointing to recent policy adjustments stating that “testing by CLIA-certified labs that had not yet acquired Emergency Use Authorization (EUA) for their COVID-19 diagnostic does not apply to at-home COVID-19 testing, ‘including self-collection of samples to be sent to a clinical laboratory,’” reported MobiHealthNews.

“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” the FDA said in a statement. “The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”

Nevertheless, the FDA stipulated that at-home specimen collection was still not authorized.

Collectively, the FDA’s two actions sent an unmistakable message to the DTC lab companies that affected their consumer COVID-19 testing plans. Following public release of the FDA’s recommendation and policy change, several of the DTC lab companies posted messages on their websites disclosing that they would not be selling COVID-19 tests with consumer self-collection after all.

Everlywell Health’s DTC Clinical Laboratory Test Plan

News stories about the plans of these companies contained details that pathologists and clinical laboratory managers will find interesting. That is certainly true of Everlywell, a DTC lab company with a distinctive background.

Austin-based Everlywell was founded in 2015 by Julia Cheek. She appeared on the Shark Tank television program in 2017 and received $1 million in funding for her business plan, which Dark Daily covered. Cheek’s plan was to sell selected medical laboratory tests directly to consumers, including placing collection kits in retail stores and pharmacies. in the same year, investors pumped another $4 million into Everlywell, for a total of $5 million in venture capital funding, reported Business Wire.

“The extreme shortage of tests for COVID-19 puts millions of Americans at risk,” said Julia Cheek (above), Founder and CEO of Everlywell, in a March 18, 2020, press release. She added, “Everlywell is committed to helping stop the spread of COVID-19 in the US by making this test widely available. As the national leader in at-home lab testing, we want to use our resources and expertise to help as many people as we can. We are committed to this fight, and we’re here to help.” A few days later, the FDA reiterated its ban on at-home COVID-19 specimen collection. (Photo copyright: Forbes/Whitney Martin.)

Everlywell, which manufactures laboratory test kits for everything from general wellness and energy/weight, to men’s health, women’s health, and sexual health, was among several companies that just days before the FDA’s warning had announced plans for an at-home COVID-19 lab test with telehealth diagnosis.

Before the FDA banned at-home testing, Everlywell had an initial supply of 30,000 collection kits and planned to work with “multiple labs to scale infrastructure,” with a goal of testing 250,000 people weekly, stated a company news release. In news interviews, Everlywell said these consumer-collected specimens would be done by CLIA-certified clinical laboratories. However, the company did not name the lab companies it expected to use to perform those tests.

Everlywell’s at-home test carried a $135 price tag for consumers, an amount the company noted was “at-cost.” Before purchasing a COVID-19 test, consumers are required to complete an eligibility questionnaire developed in accordance with CDC recommendations. Testing includes a free telehealth consultation with a board-certified physician for consumers who tested positive.

However, after the FDA issued its March 20 warning, Everlywell announced on its website that its COVID-19 test would not be available for individual purchase.

“Our frontline healthcare workers are in desperate need of testing,” the site states. “We have made the decision to allocate today’s test supply to hospitals and healthcare providers only.”

Everlywell was asked to comment on these matters by Dark Daily’s sister publication, The Dark Report. As of this date, the company has not responded to that request.

Other DTC Companies Suspend Plans to Sell At-Home COVID-19 Test Kits

The Wall Street Journal (WSJ) reported that Scanwell Health, Nurx Inc., and Curative Inc. also were among the handful of companies that curtailed plans to launch at-home COVID-19 testing following the FDA’s announcement.

Scanwell Health now plans to wait for FDA clearance under the EUA for its at-home COVID-19 blood test.

Though the US is making strides to increase testing, lack of testing capacity has hamstrung the nation’s healthcare system as it attempts to control the COVID-19 pandemic.

An at-home test would appear to be one option for increasing COVID-19 testing nationwide. However, the FDA is signaling to these direct-to-consumer lab testing companies—along with clinical laboratories—that specimen quality issues associated with consumers collecting their own samples carry the risk of producing inaccurate test results.

This is something that pathologists and medical laboratory professionals understand because the largest source of errors in clinical laboratory testing come from the pre-analytical stage. This is the part of the testing process where a specimen is collected, then transported to a laboratory and prepared for analysis at the bench.

—Andrea Downing Peck

Related Information:

FDA Says Patients Can Self-Administer Covid-19 Tests, But Not at Home

Coronavirus (COVID-1) Update: FDA Alerts Consumers about Unauthorized Fraudulent COVID-19 Test Kits

The FDA Is Forcing the CDC to Waste Time Double Testing Some Coronavirus Cases

Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics

Everlywell Announces Monday Launch of Solution to Get Tested and Diagnosed for COVID-19 from Home

Startup Aims to Produce 10,000 COVID-19 Kits a Day at Los Angeles Lab

At-Home COVID-19 Testing Services Pump the Brakes After FDA Warns Of ‘Fraudulent’ Kits

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

Why the CDC Botched its Coronavirus Testing

FDA Warns Consumers Against At-Home Coronavirus Tests Kits

FAQs on Diagnostic Testing for SARS-CoV-2

Coronavirus (COVID-19) Update: Daily Roundup

Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency

Meet the Startup Revolutionizing the Lab Testing Industry

EverlyWell Raises Additional Capital Bringing Total to $5 Million in Funding

Everlywell announces Monday launch of solution to get tested and diagnosed for COVID-19 from home

Direct-to-Consumer Clinical Laboratory Test Developer, EverlyWell, Receives $1 Million in Funding from Shark Tank Investor

Internationally-respected Experts in Clinical Pathology and Laboratory Medicine Ask: Why Don’t We Know More about Theranos’ Technology?

This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology

Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In addition, some have published their critiques of the start-up medical laboratory company in well-respected medical journals.

One question these clinical pathologists and laboratory directors ask is why Theranos has so far been unwilling to provide more information about the lab testing technology it uses to deliver medical laboratory test results to patients and their referring physicians. Even as the company has declined to speak to the medical laboratory profession, Theranos has mounted a major public relations campaign designed to make a big impression on investors, business partners, and most recently on health insurers.

The clinical laboratory company in Palo Alto, Calif., gets plenty of attention because it claims to have disruptive technology that will allow it to perform medical laboratory tests equivalent to the current standard of care. Theranos says it can do this using a capillary specimen and return results in four hours, while charging a price that is just 50% of Medicare Part B lab test fees. Given these assertions, it is natural that pathologists and laboratory scientists who perform tests for patients, are curious about the scientific basis of Theranos’ proprietary diagnostic technology and what evidence Theranos has developed to support its claims of comparable accuracy and reproducibility. (more…)

New Microfluidic Blood-draw Device Could Replace Needle Sticks and Venipunctures at Medical Laboratories

By placing this low-cost, disposable device developed at the University of Wisconsin-Madison on their arms or abdomens, patients can collect their own blood at home in minutes

For more than two years, the nation’s media have been captivated by Theranos CEO Elizabeth Holmes’ vision of offering patients who need blood tests a finger stick collection instead of a venipuncture. Meanwhile, in research labs across the nation, there are credible efforts to develop ways to collect medical laboratory test specimens that require no needles at all.

On such effort may soon enter the market. It is an innovative, needleless blood-collection device called HemoLink developed by a research team at the University of Wisconsin-Madison. Users simply place a device with the diameter of a golf ball against their arms or abdomens for two minutes. During that time, the device draws blood from capillaries into a small container. Patients would then mail the tube of collected blood to a medical laboratory for analysis.

This non-threatening device is ideal for children. However, patients who require recurrent blood tests to monitor health conditions would also benefit, as it would save them frequent trips to clinical laboratories for blood draws using traditional needle-stick methods. (more…)

Company’s Goal Is to Reduce Consumer’s Need to Visit Clinical Laboratories by Developing a Test Device for Home Monitoring of Fitness and Pre-Existing Conditions

Flow Health Hub device could be disruptive to medical laboratories, as it will be designed to allow patients to perform their own diagnostic tests to monitor pre-existing conditions

Another biotech company has its eye on medical laboratory testing and wants to bring to market what it describes as a consumer do-it-yourself test device. The company is designing the device to let consumers do fitness monitoring. But it hopes the device will also allow consumers to monitor pre-existing conditions without the need to visit a clinical laboratory.

These are ambitious goals for Cambridge Consultants, a health IT engineering and technology development firm in Massachusetts. The device under development is the Flow Health Hub, which company executives say can bring the power of the clinical laboratory into the home, according to a Cambridge Consultants press release.

Though still in the conceptual phase, the developer suggests that the user-friendly device could negate the need to visit medical laboratories for routine tests. That would save time and money for both patients and their doctors. (more…)

Geneticist at University of California Davis Sequences His Unborn Baby’s DNA in a Global First for Whole Genome Sequencing

Prenatal genome sequencing raises ethical issues for gene sequencing labs and clinical labs, since a baby’s genetic information may present lifelong consequences for that individual

Pathologists and clinical laboratory managers will be interested to learn that another milestone in genetic testing was reached earlier this year. A geneticist at the University of California at Davis, has sequenced the whole human genome of his unborn baby, the first time this feat has been accomplished.

Notably, it was geneticist and graduate student Razib Khan of the UC Davis School of Veterinary Medicine who sequenced his unborn son’s genome during the third trimester of pregnancy using a sample of the fetus’ placenta. This is the first healthy person born in the United States with his entire genetic makeup deciphered prior to birth, noted a recent story published by the MIT Technology Review(more…)