Roche has announced that the US Food and Drug Administration (FDA) has granted 501(k) clearance for the diagnostic use of its whole-slide imaging system, Roche Digital Pathology Dx.

In 2019, China's IVD market size exceeded 71 billion CNY, with a year-on-year growth of 15%, of which, the biochemical diagnosis market accounted for 23%; in 2020, China's IVD market size exceeded 100 billion CNY, of which, the biochemical diagnosis market accounted for 18%. Although the biochemical market share in 2020 is lower than that in 2019, the market size in 2020 has increased by nearly two billion CNY compared with 2019.

Chinese biotech MGI Tech and France’s SeqOne Genomics are partnering to advance an end-to-end solution for genomic testing.

Siemens Healthineers said on Monday that the firm has received CE marking for a prognostic blood test that the firm plans to launch later this year in Europe to aid the management of multiple sclerosis.

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

The US Food and Drug Administration has granted Emergency Use Authorization to Healgen Scientific for a point-of-care combination antigen test for COVID-19 and influenza A/B.

Roche announced this week that its Ventana PD-L1 (SP263) assay received a CE-IVDR label expansion for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy in lung cancer patients.

Challenge Works said Wednesday that it has awarded an £8 million prize to Sweden's Sysmex Astrego for its development of a point-of-care urinary tract infection test that delivers antibiotic susceptibility information in 45 minutes.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the release of a new version of its clinical decision support software, QIAGEN Clinical Insight Interpret (QCI Interpret), that brings significant performance and scalability enhancements tailored for high-throughput, next-generation sequencing (NGS) labs moving to larger test panels and higher test volumes. The latest version of QCI Interpret introduces improvements that accelerate critical lab performance criteria for turn-around-time, diagnostic yield and quality results.

Myriad Genetics announced Tuesday that GlaxoSmithKline is sponsoring a program to boost access to homologous recombination deficiency (HRD) diagnostic testing for high-grade serous ovarian cancer (HGSOC) patients in nine countries via Myriad's MyChoice HRD Plus and MyChoice CDx Plus tests.

Foundation Medicine, Inc., today announced that it has formed a collaboration with Repare Therapeutics, a leading clinical-stage precision oncology company, to provide prospective genomic profiling to patients in Repare’s ongoing Phase I/Ib MYTHIC study (NCT04855656) of lunresertib alone or in combinations in genomically-defined patient populations. The companies are also exploring opportunities to develop FoundationOne®CDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program.

The 26th International Congress of Clinical Chemistry and Laboratory Medicine - IFCC WorldLab Congress organized jointly with the 17th Congress of the Arab Federation of Clinical Biology, 10th Annual Meeting of the Saudi Society for Clinical Chemistry and 8th International and United Arab Emirates Genetic Disorders Conference successfully convened in Dubai from 26-30 May 2024.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of 35 new wet-lab tested digital PCR Microbial DNA Detection Assays for its digital PCR (dPCR) platform QIAcuity, significantly enhancing its offerings in the field of microbial research. The new assays are available on QIAGEN’s comprehensive research platform GeneGlobe and are designed to target a wide range of pathogens responsible for tropical diseases, sexually transmitted infections (STIs) and urinary tract infections (UTIs), further solidifying QIAGEN's position as a leader in microbial detection and analysis.

Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced that it has completed its previously announced acquisition of PathAI Diagnostics from PathAI, with the goal to accelerate the adoption of AI and digital pathology to improve the diagnosis of cancer and other diseases.

Zybio obtained the registration certificate and patent for the Lp-PLA2 assay kit (rate method) in 2015. The performance of the kit can reach the international leading level by using an innovative substrate design and reagent formula.