On September 23, FDA sent a letter to all manufacturers that received EUA authorization for COVID-19 tests, urgently notifies all these manufacturers of three new requirements for their EUA-authorized tests.

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

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.

The US Food and Drug Administration has granted 510(k) clearance and a CLIA waiver to a multiplex assay from Visby Medical to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The assay uses an instrument-free, single-use PCR device.

The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Mount Sinai Hospital and Empire City Laboratories.

Thermo Fisher Scientific said on Wednesday that the US Food and Drug Administration has granted pre-market approval to the company's Oncomine Dx Target Test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA)

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.