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 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.