COVID-19 home tests
Exact Sciences of Madison gets approval to process specimens.
Exact Sciences has won regulatory approval to process COVID-19 tests from specimens taken by people in their homes.
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.
The FDA approval will enable 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 process those tests can be modified to look for genetic markers of the coronavirus.
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 and Wisconsin State Laboratory of Hygiene, 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.
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.