Exact Sciences wins regulatory approval for home COVID-19 tests; home test must be ordered by clinician, then sent to lab for analysis

Exact Sciences has won regulatory approval to process COVID-19 tests from specimens taken by people in their homes.

a man standing on a table: Exact Sciences Laboratories, Madison, WI.

© Exact Sciences
Exact Sciences Laboratories, Madison, WI.

The Food and Drug Administration gave approval for the company to test specimens collected using two home collection kits, including one from Exact Sciences.

The tests must be ordered by a physician or other clinician and the collection kit — basically a swab, tube with saline solution, label and packaging material — then is sent to the patient.

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The kit allows the patient to do their own nasal swab and mail the specimen to Exact Sciences for processing. This enables patients, such as those diagnosed through  virtual visits to be tested without going to a clinic or community testing site.

Exact Sciences, based in Madison, is best known for Cologuard, a noninvasive test that looks for genetic markers of colon cancer. The instruments that processed those tests can be modified to look for genetic markers of the coronavirus.

500,000 tests

The company — which employs about 2,600 people in the Madison area and 4,500 worldwide — moved quickly when the pandemic first hit the United States, working with the state and its suppliers, to convert some of its equipment to process COVID-19 tests and meet the surge in demand for the tests. It won federal approval to begin processing the tests in mid-April.

As of mid-July, it had processed more than 500,000 COVID-19 tests, including about 400,000 from people who live in Wisconsin, said Scott Larrivee, a company spokesman.

Exact Sciences is processing more than 20,000 tests a week for the Department of Health Services, he said. The tests are being processed in 72 hours or less.

Larrivee could not comment on the company’s customers in other states.

The tests on specimens taken from the home-collection kits still must be ordered by a physician or other clinician, Larrivee stressed, and the tests will not be available in retail settings.

How the process works

The order is placed by the clinician and the kit sent to the patient’s home by Exact Sciences or Everlywell, which makes the other home collection-approved kit. The kits are then returned to Exact Sciences by the patient. The lab at Exact Sciences will then conduct the test on the specimen to determine whether genetic markers of COVID-19 are present.

The test results are then sent by Exact Sciences to the healthcare provider, who is responsible for reporting the result and next steps to the patient, according to the FDA.

Exact Sciences reported $34.6 million in revenue from COVID-19 tests, out of total revenue of $268.9 million, for its quarter ended June 30.

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This article originally appeared on Milwaukee Journal Sentinel: Exact Sciences wins regulatory approval for home COVID-19 tests; home test must be ordered by clinician, then sent to lab for analysis

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