Becton Dickinson announced Wednesday that it has received US Food and Drug Administration approval for its automated, sample-to-answer, high-throughput BD Cor system along with the BD Onclarity HPV Assay for extended genotyping of human papillomavirus.

AnPac Bio-Medical Science, a cancer screening and detection company, said on Monday that it has filed for registration testing of its Class III, multi-cancer detection device with China's National Medical Products Administration.

Tempus said on Tuesday that it has submitted a premarket approval application for its next-generation sequencing-based xT-Onco tumor profiling assay to the US Food and Drug Administration.

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.

A newly finalized guidance from the US Food and Drug Administration (FDA) helps manufacturers understand how to use near-infrared (NIR)-based analyses in evaluating drug attributes.

DiaSorin said on Friday that its second quarter revenues rose 20 percent year over year, driven by strength in molecular diagnostic test sales.

Quidel has issued a recall for certain lots of its Lyra brand SARS-CoV-2 tests due to the potential for false negative results in patient samples with relatively high amounts of virus.

The US Food and Drug Administration recently granted separate Emergency Use Authorization for molecular SARS-CoV-2 tests from Exact Sciences and BioGx, an immunoassay for detecting the virus from Bio-Rad Laboratories, and an at-home specimen collection kit from Everlywell.

Roche announced recently that its RT-PCR-based Cobas SARS-CoV-2 nucleic acid test for use on the Cobas Liat system has received Emergency Use Authorization from the US Food and Drug Administration.

A new antibody testing study examining samples originally collected through the National Institutes of Health’s All of Us Research Program found evidence of SARS-CoV-2 infections in five states earlier than had initially been reported.