The US Food and Drug Administration said on Wednesday that its Center for Devices and Radiological Health (CDRH) is planning a process to reclassify some high-risk in vitro diagnostics as moderate risk in a move that the agency said would allow manufacturers to seek marketing clearance for their tests through a less stringent regulatory pathway.

DiaSorin on Thursday said it has submitted for US Food and Drug Administration approval an immunoassay for the early identification of Lyme disease.

Molecular diagnostic firm T2 Biosystems announced Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration to expand the use of its T2Candida Panel for pediatric testing.

Virax Biolabs said on Thursday that it has formed an alliance with the University of Manchester and Northern Care Alliance Foundation Trust, a member organization of the UK's National Health Service, to investigate T-cell responses in long COVID-19 patients.

Siemens Healthineers said Monday that it has secured a three-year, $5.5 million contract with the National Institute of Allergy and Infectious Diseases to develop a next-generation sequencing-based test to guide antimicrobial treatments in sepsis patients.

EliTechGroup announced on Thursday that it has received certification under Europe's In Vitro Diagnostic Regulations for multiple infectious disease tests.

Agilent Technologies Inc. (NYSE: A) today announced the signing of a Memorandum of Understanding (MOU) with the Sarawak Infectious Disease Centre (SIDC) in East Malaysia.

Streck announced on Monday that its MDx-Chex quality controls have received clearance from the US Food and Drug Administration.

T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.

Danaher on Tuesday announced that it will provide Cepheid's tuberculosis test to the Global Fund to Fight AIDS, TB, and Malaria, as well as to less-developed countries eligible for Cepheid's Global Access Program, at cost.