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

Lymphoma, also known as malignant lymphoma, is a general term for a group of malignant tumors originating from the lymphopoietic system. It is one of the most common tumors in China. In 2020, there were 544,352 new cases of non-Hodgkin lymphoma (NHL) worldwide, ranking 13th among all new cases of malignancies.

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).

Beckman Coulter Diagnostics, a global leader in advanced diagnostics, today announced availability of new Research Use Only (RUO) blood-based biomarker immunoassays designed to advance neurodegenerative disease research. These assays are intended to assess p-Tau217, GFAP, NfL, and APOE ε4 biomarkers, which are emerging as the most important biomarkers in neurodegenerative diseases research, including interventional clinical trials.

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.

Werfen today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents.

bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has entered into an agreement to acquire SpinChip Diagnostics ASA (“SpinChip”), a privately held Norwegian diagnostics company that has developed a game-changing immunoassay diagnostics platform. The small benchtop analyzer is well adapted to near patient testing as it can deliver a result from a whole blood sample within 10 minutes with the same high-sensitivity performance as the laboratory instruments. bioMérieux has held a minority stake in SpinChip since March 2024.