Exact Sciences has received regulatory approval for COVID-19 testing from samples taken from people living at home.
The Food and Drug Administration (FDA) legalized the company to verify samples taken in two sample kits in the house, adding one from Exact Sciences.
Tests should be prescribed through a doctor or other clinician and then the pattern kit, necessarily a swab, a tube containing a saline solution, a label and a packing cloth, will be sent to the patient.
FDA approval will allow patients, such as those diagnosed with telehealth or virtual visits, to be tested without having to go to a clinic or network testing site.
Exact Sciences, founded in Madison, is known for Cologuard, a noninvasive control that looks for genetic markers of colon cancer.Tools that have treated these controls can be changed to look for genetic markers of coronavirus.
The company, which employs about 2,600 more people in the Madison domain and 4,500 internationals, temporarily reacted when the pandemic first struck the United States, in collaboration with the state and its suppliers, to convert some of its devices into the COVID-19 procedural tests and meet the highest call for testing. It received federal approval to begin testing in mid-April.
By mid-July, he had processed more than 500,000 COVID-19 tests, adding about 400,000 other people living in Wisconsin, said Scott Larrivee, corporate spokesman.
Exact Sciences processes more than 20,000 tests a week for the Wisconsin Department of Health Services and Health Laboratory, he said.Tests are processed in hours or less.
Larrivee may simply comment on the company’s consumers in other states.
Tests on samples taken from home collection kits deserve to be ordered through a physician or other clinician, Larrivee emphasized, and the tests will not be available in retail stores.
The order is placed through the doctor and the kit is shipped to the patient’s home through Exact Sciences or Everlywell, which causes the other kit to be approved for home collection. Kits are returned to Exact Sciences through the patient.the pattern of whether COVID-19 genetic markers are present.
Exact Sciences reported $34.6 million of coVID-19 tests, totaling $268.9 million, for the quarter ending June 30.