Providers Get Creative as FDA Clears More IVD Firms’ Tests

Hospital CEO mortgages his home to buy COVID-19 test kits; POC tests get FDA EUAs

CEO SUMMARY: Clinical and molecular test laboratories, hospitals, public health agencies, and other providers are taking unusual measures to expand the number of tests available to identify the spread of the new coronavirus. When a hospital needed funding to buy test kits for the disease, the president of the facility used his own personal funds. When two residents of a resort town in Colorado wanted to test all 8,000 residents in their county, they partnered with county health officials and their test company will pay for the tests.

EVEN AS MULTIPLE IN VITRO DIAGNOSTIC (IVD) COMPANIES were obtaining FDA EUAs for their COVID-19 tests, providers here and abroad were getting creative in their responses to the global outbreak of SARS-CoV-19.

After weeks of national news reports on regulatory hurdles preventing clinical labs from quickly delivering validated COVID-19 tests for clinical use, officials at the federal Food and Drug Administration (FDA) got the message: Healthcare professionals and the American public wanted COVID-19 tests NOW!

In recent days, the FDA issued emergency use authorizations (EUAs) for a growing number of test kits and instrumentsused to perform the tests. Included were these three EUAs:

• An EUA on March 27 for Abbott Laboratories to offer its ID Now COVID-19 test, a point-of-care molecular test that physicians can use in their offices.

• An EUA on March 20 for Cepheid’s Xpert Xpress SARS-CoV-2 point-of-care COVID-19 diagnostic test for use in CLIA-certified moderate- and high-complexity labs. Results are available in 45 minutes.

• An EUA on March 23 for bioMérieux’s BioFire COVID-19 45-minute test for use in CLIA-certified moderate- and high-complexity labs.

(See sidebar, “In Recent Days, at Least Three Companies Get EUAs for Point-of-Care and Rapid-result COVID-19 Tests,” below.)

Home Equity to Fund Tests

Two examples of innovative thinking include a countywide testing program in Colorado and a hospital CEO in Florida who leveraged the equity in his home to buy thousands of test kits.

When Jack Michel, MD, President of Larkin Community Hospital (LCH) in South Miami, needed funding to buy 50,000 kits to test for COVID-19, he tapped the equity in his home to the tune of $380,000, the Associated Press (AP) reported. “It wasn’t easy telling my wife,” Michel commented.

Seeking to boost testing, LCH leased a machine from Hologic to run more than 1,000 COVID-19 tests per day, but then had to wait to get approval to use the instrument. While waiting for regulatory approval, LCH sent patient specimens to BioReference Laboratories and got results in 48 hours, the AP reported.

Still, LCH could not test all patients who needed testing. Another way to increase COVID-19 testing at the hospital was to pay upfront to Path-Tec, a kit developer and specimen management company in Midland, Ga., for the test kits. Since the hospital’s finances were already overextended, Michel paid the $380,000 himself, the AP wrote.

With those kits in hand, LCH opened a drive-through test site in Hialeah and plans to offer more tests in the coming weeks. The hospital charges $150 per test, a price Michel said was needed to allow LCH to make more tests available.

Countywide Testing

In another example of an extraordinary measure, two executives of United Biomedical, a biotech company in Hauppauge, N.Y., that develops lab test kits and vaccines, will have their company pay to test all 8,000 residents of San Miguel County, Colo., for COVID-19 infections.

The executives are Mei Mei Hu, co-founder and member of the executive committee and board of directors of United Biomedical, and her husband, Lou Reese, co-founder and board member.

In addition to its offices in New York, the multinational company has operations in China, Ireland, and Taiwan. Earlier this year, United Biomedical formed a division called c19 to develop a serologic assay called SARS-CoV-2 ELISA that detects antibodies from COVID-19 infections in human serum specimens or plasma.

On March 18, county health officials announced a partnership with c19, saying they believed the county would be the firstto test all residents. The county also has a shelter-in-place order.

To identify the prevalence of the disease in Colorado’s southwest corner, the county’s Department of Public Health and Environment will administer the testing, which is voluntary. Hu and Reese have a home in the ski resort town of Telluride, which has a population of about 3,000. “This will drastically advance our ability to assess the presence of the virus in our county and allow us to focus isolation strategies,” Grace Franklin, the county’s Director of Public Health, said in a news release.

Retesting 14 Days Later

County officials will have healthcare providers administer the test, and they expect results within two days. Fourteen days later, they’ll repeat the tests to assess whether the rate of infection has gone up or down.

The town of Vò in the Lombardy region of northern Italy completed a similar dual-testing and shelter-in-place initiative that officials credited with limiting the spread of infections there.

Hu told The Atlantic magazine that United Biomedical started working on an antibody test in January after the outbreak in China. The company’s scientists applied what they learned from developing an ELISA test for SARS in 2004 and got blood samples from COVID-19 patients to confirm that the test detects antibodies against the virus.

Serology Tests for COVID-19

Clinical lab scientists are interested in the possibility of detecting the antibodies that result from such infections because if serological testing can find asymptomatic carriers of COVID-19, it could help health professionals understand the disease’s transmission and fatality rates, the magazine reported.

On its website, United Biomedical (UB) explained that, once infected with the SARS-CoV-2 virus, the individual’s immune system produces antibodies that bind to the proteins the virus generates.

That process takes about eight to 10 days to produce enough antibodies for serological tests to identify in blood samples.

UB also said the FDA required that it provide a disclaimer to the public. The FDA has not reviewed the test and negative results do not rule out SARS-CoV-2 infection, the disclosure said, and that results from antibody testing should not be used as the only way to diagnose or exclude SARSCoV-2 infection. “Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains and follow-up testing with a molecular diagnostic test should be considered to rule out infection,” said United Biomedical.


In Recent Days, at Least Three Companies Get EUAs for Point-of-Care and Rapid-result COVID-19 Tests

IN MARCH,  the FDA granted emergency use authorizations (EUAs) to Abbott Laboratories, bioMérieux, and Cepheid for point-of-care or rapid-result molecular tests to identify the new coronavirus.

FDA issued the latest EUA for such a test on March 27 to Abbott for its ID NOW COVID-19 test. The assay delivers a positive result in five minutes and a negative result in 13 minutes, making it “the fastest available molecular point-of-care test for the detection of novel coronavirus,” Abbott said. On Twitter, former FDA Commissioner Scott Gottlieb, MD, called it a “game changer.”

Days earlier on March 20, the FDA granted an EUA for a point-of-care COVID-19 diagnostic to Cepheid for its Xpert Xpress SARS-CoV-2 test. The agency said the test could be used in high- and moderate-complexity CLIA-certified laboratories and in certain patient care settings.

The Size of a Toaster

Abbott said the ID NOW COVID-19 test is a point-of-care molecular test that physicians can use in their offices. Beginning the week of March 30, the company aims to deliver 50,000 ID NOW COVID-19 tests per day.

While speed is important, another positive feature is that the Abbott machine which runs the ID NOW tests weighs less than seven pounds and is the size of a small toaster. Therefore, it may find a home in physicians’ offices or urgent care clinics.

Like Abbott, Cepheid intends to rollout its point-of-care test right away and is aiming for March 30 as well.

The company’s fully-automated molecular test is based on the design principles of the technology it uses in its current Xpert Xpress Flu/RSV cartridges to target multiple regions of the viral genome.

“The test can provide rapid detection of the new coronavirus in about 45 minutes and requires less than one minute of hands-on time for a technician to prepare the sample,” the company said.

It can be used in multiple settings where actionable test results are needed to make informed treatment decisions quickly, and it delivers results with the same level of performance that reference labs produce, the company added.

Cepheid has 23,000 GeneXpert Systems installed worldwide

On March 23, bioMérieux subsidiary BioFire Defense received its EUA. The company developed the BioFire COVID-19 test with funding from the federal Department of Defense (DoD). While bioMérieux increases test production, the initial run of test kits is committed to the DoD for redistribution, the company said.

The test is designed for CLIA-certified moderate- and high-complexity clinical laboratories and can detect SARS-CoV-2 in about 45 minutes from a nasopharyngeal swab in transport media.

The test runs on automated platforms and requires minimal training and skills in molecular biology.


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