Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status.

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.

3.3 Tumor Companion Diagnostic Reagents Non-small Cell Lung Cancer Companion Diagnostic Tests High-throughput sequencing (HTS) has started to be applied in tumor companion diagnosis in recent years..

Danaher and Fudan University’s Huashan Hospital Partner to Develop Alzheimer’s Diagnosis Technology On January 20, Danaher, a global leader in science and technology innovation, announce..

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).

Original from: Beckman Coulter Beckman Coulter Diagnostics, a global leader in advanced diagnostics, today announced availability of new Research Use Only (RUO) blood-based biomarker immunoassays designe..

Beckman Coulter and Health Genetech Forge a Strategic Partnership in Ningbo On January 8, Health Genetech and Beckman Coulter entered into a strategic cooperation agreement, aiming to driv..

Mirxes, a leading RNA technology company specializing in early cancer detection and precision medicine, today announced a US$40 million structured financing transaction with CBC Group’s R-Bridge Healthcare Fund (“R-Bridge”). This partnership will provide critical support for Mirxes’ ambitious growth and expansion into key global markets.

Revvity, Inc. (NYSE: RVTY), today announced a strategic agreement to commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing, co-developed with Element Biosciences, Inc., a life science company democratizing access to advanced DNA and multi-omic sequencing solutions. This initiative builds upon Revvity's recent introduction of an automated next-generation sequencing (NGS) workflow for newborn sequencing research and strengthens Element’s momentum towards regulatory approval of the benchtop AVITI™ sequencing system.