Watmind USA has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its SpeedySwab Covid + FLU A&B Self-Test.

Illumina, Inc. (NASDAQ: ILMN) today announced that its Board of Directors has approved the spin-off of GRAIL. GRAIL is anticipated to spin off from Illumina on June 24, 2024, and has applied to list on Nasdaq as "GRAL."

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

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) has recently announced a collaboration with Bayer to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx), aiming to provide diagnostic methods, to enable treatment choice for patients with cancer in China, while driving innovation and development in cancer therapy. This collaboration will focus on the development of companion diagnostic products in China, jointly developing NGS-based CDx for Bayer's growing portfolio of precision cancer therapies.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies.

Oxford Nanopore Technologies has launched a new Pharmacogenomics (PGx) Beta Program with Twist Biosciences.

Point-of-care diagnostic firm Cue Health is laying off all of its employees and shuttering its operations.

T2 Biosystems announced Wednesday that it has regained compliance with a listing requirement to remain on the Nasdaq.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue.

In the First Catalogue of Rare Diseases, which was jointly developed by the National Health Commission of the PRC and five other departments in 2018, there is a rare disease called IgG4-Related Disease (IgG4-RD).

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.

The UK Medicines & Healthcare Products Regulatory Agency on Tuesday published a proposed framework for the recognition of in vitro diagnostics that have already been cleared in other jurisdictions.

With the application of the latex-enhanced immunoturbidimetry and the enzyme immunoassay amplification, the sensitivity of biochemical test items is greatly improved. Representative products applied in the biochemical technology platform in 2019-2020 are as follows:

The American Society of Clinical Oncology on Friday released guidelines to help guide use of multigene germline genetic testing panels for cancer patients.

Karius®, Inc., a leader in genomic diagnostics for infectious diseases, announced today that the Karius Test® has been granted designation as a Breakthrough Device from The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA), for use in the diagnosis and management of immunocompromised patients with suspected lung infections including lower respiratory infection and pneumonia.