At present, domestic blood typing reagent-related products already covered ABO blood typing, test of Rh and other irregular antibodies, and anti-human globulin test.

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

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas® liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. market in the coming months, with commercialisation under CE mark expected to follow shortly.

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

High-throughput sequencing (HTS) has started to be applied in tumor companion diagnosis in recent years.

Omics firm Sapient said Wednesday that it has partnered with Alamar Biosciences to provide proteomics services using Alamar's NULISA multiplexed immunoassay platform.

Teal Health, a women’s health company on a mission to eliminate cervical cancer in the US, announced today the close of an additional $10 million in seed funding to support the upcoming launch of the Teal WandTM, which is currently under FDA review and on track to be the US market's first FDA-approved at-home self-collect cervical cancer screening device. This new capital brings Teal Health’s funding to $23 million to date as the company accelerates its product development and readies go-to-market plans.

Kryptos Biotechnologies said this week that the Research Investment for Global Health Technology (RIGHT) Foundation has awarded it $1.2 million to further develop its molecular diagnostic testing system for use at the point of care.

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA.

Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy® for applications in early disease detection and precision medicine, today announced a first closing of $27 million (circa £22 million) in its Series E financing round. The fundraise was led by Ventura Capital, joined by Aviva Ventures, Horizons Ventures, and other existing investors. The close also saw completion of the investment from the Gates Foundation.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and ConcertAI, a leading oncology real-world evidence data and AI SaaS technology company, today announced a collaboration agreement that allows biopharmaceutical companies to access the first multi-modal real-world data (RWD) that integrates comprehensive patient electronic medical record (EMR) data with both genomic and epigenomic tumor profiling information across the continuum of cancer care.

A respected organization acclaimed for their groundbreaking work with neurological diseases, C2N Diagnostics, LLC, is partnering with The Michael J. Fox Foundation For Parkinson’s Research (MJFF) to better understand the connections amongst neurodegenerative conditions, Alzheimer’s disease (AD) and neuronal a-synuclein disease (NSD), which encompasses Parkinson’s disease (PD), Lewy body dementia (LBD) and REM behavior disorder (RBD).