PerkinElmer subsidiary Oxford Immunotec said Thursday it gained US Food and Drug Administration approval for its T-Cell Select reagent kit that automates sample preparation steps for its tuberculosis in vitro diagnostic assay.

Roche announced on Monday that its Cobas Pure Integrated Solutions instrument has received 510(k) clearance from the US Food and Drug Administration.

DiaSorin said Wednesday it had gained US Food and Drug Administration 510(k) clearance for a swab-based COVID-19 PCR assay that delivers results in about one hour.

Oxford Nanopore Technologies reported on Tuesday morning that its revenues in the first half of 2022 more than doubled year over year, driven by COVID-19 testing.

Becton Dickinson and Viramed Biotech each gained US Food and Drug Administration 510(k) clearance in August for panels to differentiate pathogenic illnesses, and a Werfen subsidiary got the go-ahead for a panel used to evaluate coagulation pathways and Vitamin K antagonist treatment.

The US Department of Health and Human Services announced on Wednesday that it has authorized the Food and Drug Administration to issue emergency use authorizations for monkeypox tests.

UK-based molecular diagnostics system developer QuantuMDx said on Tuesday that it has entered into a global R&D, manufacturing, and commercial partnership agreement with Sansure Biotech aimed at commercializing its Q-POC system and assays in China.

Stock price review: centralized procurement VS epidemic, differentiated growth and excess earnings. Two peaks in January 2022 and March-April 2022. IVD, low-value consumables, etc. performed prominently, mainly driven by the epidemic

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

Biocartis on Thursday reported a 21 percent year-over-year increase in revenues for the first half of 2022 as higher collaboration revenue offset a decline in SARS-CoV-2 product sales.