IVD

Genetic variants of SARS-CoV-2, the virus the causes COVID-19, may lead to false negative results with molecular tests for the virus. So what is FDA doing about it?

The companies will develop AlloID, a tailored infectious disease testing solution that identifies more than 100 pathogens and drug resistance in viruses and bacteria, specific to organ transplant donors and recipients.

The Marlborough, MA-based company said it would acquire Biotheranostics for $230 million.

FDA has authorized over 300 COVID-19 tests and collection kits, but these tests are not all created equal. Here are the tests that have been flagged for potential false results.

The chairman of the Senate health committee has dubbed a new low-cost, at-home, diagnostic a "genuine breakthrough" in COVID-19 testing.

Geneoscopy's stool-based colorectal screening tool is designed to detect both colorectal cancer and precancerous adenomas.

The use of Roche’s test will help provide a quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between Moderna’s vaccine-induced protection and levels of anti-receptor binding domain antibodies.