As part of its strategic expansion into precision dermatology, Castle Biosciences recently introduced a new assay to guide systemic treatment decision making for the immune-driven disease atopic dermatitis. Castle expects to expand the limited launch of its AdvanceAD-Tx test over the next year to pursue a total addressable market that it estimates to be as much as $33 billion.

Diagnostics firm IdentifySensors Biologics has recently demonstrated proof of concept for the use of its electrochemical sensor-based diagnostic platform Check4 for cancer testing and is now moving closer to commercialization of the platform and related tests.

JP Morgan, BTIG, and Jefferies announced separately Monday that they have initiated coverage of molecular diagnostics firm BillionToOne.

Sapphiros today announced a strategic supply and manufacturing option agreement with Roche that will grant exclusive rights to lateral flow technology manufacturing capacity to at least 1 billion tests annually from Sapphiros' extreme volume manufacturing process installed in the UK. The reel-to-reel manufacturing capability of Sapphiros can produce up to 5 billion diagnostics per year.

Diasorin (FTSE MIB: DIA) today announced the signing of a supplier agreement with Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services based in and serving the United States.

Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. The company also announced that the assays obtained CE marking in the European Union in accordance with In Vitro Diagnostic Regulation (IVDR). These highly sensitive molecular tests are designed to rapidly detect the most common bacterial pathogens responsible for infectious gastroenteritis.

Hitachi High-Tech Corporation ("Hitachi High-Tech"), and ELITechGroup S.p.A. (Head Office: Italy, "ELITech") have entered a Collaboration, Manufacturing and Supply Agreement (the "Agreement") in the field of molecular testing for infectious disease.

Biocartis Group of Companies (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ CDx MSI Test developed in partnership with Bristol Myers Squibb, has received the first-ever Premarket Approval (PMA) from the FDA for a cartridge-based, fully automated, “sample-to-result” companion diagnostic test.

Cyted Health, a leading gastrointestinal (GI) molecular diagnostics company, today announces a first close of $44 million in its Series B financing round to accelerate its ongoing US expansion.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.