Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

On May 8, Singlera Genomics announced that its self-developed PDACatch test, a novel DNA methylation-based liquid biopsy test for detecting pancreatic cancer in high-risk populations, has been granted Breakthrough Medical Device designation by FDA.

BioMérieux announced on Tuesday that its BioFire SpotFire Respiratory Panel Mini has obtained CLIA wavier from the US Food and Drug Administration.

Meridian Bioscience said Wednesday the US Food and Drug Administration has cleared the firm's Curian Shiga Toxin immunoassay, expanding the firm's gastrointestinal disease product line.

BioMérieux said Friday it is seeking US Food and Drug Administration 510(k) clearance that would allow a US launch of its Vitek Reveal rapid antimicrobial susceptibility testing system to help guide treatment of bacterial sepsis.

Danaher subsidiary Leica Biosystems said Monday that it secured US Food and Drug Administration 510(k) clearance for its Bond MMR Antibody Panel to help identify potential Lynch syndrome in colorectal cancer patients.

The US Food and Drug Administration this week released its guidance document for developers of medical devices for COVID-19, including diagnostic tests, on how to transition from Emergency Use Authorization to full marketing and regulatory authorization.

Supplies of laboratory reagents, testing components and transport media are expected to normalize in the first half of 2023, ending shortages that date back to early in the pandemic, according to the Food and Drug Administration.

Genomadix announced on Wednesday that the US Food and Drug Administration has granted 510(k) clearance to its automated sample-to-result Genomadix Cube PCR system and CYP2C19 test.

DiaSorin said late Friday that it has nabbed US Food and Drug Administration 510(k) clearance for a molecular assay that differentiates between infections with the SARS-CoV-2 and influenza A and B viruses.