The agency is requiring test developers to monitor emerging mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.

Investigators have determined that high-risk HPV DNA can be detected in saliva in most patients with HPV-driven oropharyngeal cancers at the time of diagnosis.

The US Department of Defense announced on Friday that in coordination with the US Department of Health and Human Services it has awarded four procurement contracts totaling $647 million to four companies to purchase over-the-counter COVID-19 test kits.

DiaSorin Molecular announced on Monday that its Simplexa COVID-19 & Flu A/B Direct test has received CE marking.

Thermo Fisher Scientific said on Thursday that it has received CE-IVD marking for its TaqPath COVID-19 RNase P 2.0 kit, which has been designed to provide accurate results by compensating for current and future COVID-19 viral mutations.

Cepheid announced on Tuesday that it has received Emergency Use Authorization from the US Food and Drug Administration for a new version of its multiplex SARS-CoV-2, influenza, and respiratory syncytial virus test.

Co-Diagnostics on Thursday after the close of the market posted a 14 percent year-over-year increase in second quarter revenues on continued demand for its Logix Smart COVID-19 test.

The US Food and Drug Administration this week granted separate Emergency Use Authorizations for two PCR-based SARS-CoV-2 tests from Amazon subsidiary STS Lab Holdco and one from the Cleveland Clinic.

On May 11, BioPerfectus officially announced that their COVID-19 test kit for B.1.617 has been successfully developed.

Recently, COVID-19 (SARS-CoV-2) Antigen Test Kit independently developed by Wuhan Easy Diagnosis passed the performance verification of Paul-Ehrlich-Institut in Germany.