Agilent Technologies Inc. today announced its Ki-67 IHC MIB-1 pharmDxis now FDA approved as an aid in identifying patients with early breast cancer at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered.

FDA brought medtech up to speed on several key medical device programs during the CDRH Townhall at The MedTech Conference.

Laboratory Corporation of America said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a combined home collection kit for molecular testing for COVID-19 and influenza A/B.

ANP Technologies announced on Monday that its SARS-CoV-2 rapid antigen test has received Emergency Use Authorization from the US Food and Drug Administration.

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)