Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended June 30, 2023.

MHRA automatically moved the U.K.’s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices 11 months ago.

An international team of researchers has developed a PCR-based assay to detect mitochondrial DNA (mtDNA) damage in blood, an indicator of Parkinson's disease. The test may help diagnose the condition before the nervous system of patients is excessively damaged, they said, and could be used to measure response to certain drugs in development to treat the disease.

Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic information services, today announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

On August 13th, China's State Council issued a 24-point guideline covering six areas.

Ginkgo Bioworks said Tuesday that it has formed a five-year partnership with Google Cloud to develop large language models for genomics, protein function, and synthetic biology. The companies hope that the collaboration will support cell programming and biosecurity to help advance fields including drug discovery, agriculture, and industrial manufacturing.

VC investment in medtech fell across 2022, and the downward trend in deal value continued in the first quarter of 2023. The second quarter brought potential signs that a recovery is starting. Deal value ticked up from $2.5 billion to $2.8 billion between the first and second quarters, and the number of deals rose from 183 to 189.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

By studying cell-free DNA methylation (cfDNAme) patterns among pregnant women, researchers in Belgium have developed a liquid biopsy screening test to identify women at risk of early-onset preeclampsia (PE).

Medical tool supplier Danaher (DHR) is expanding its product offerings by purchasing British biotech firm Abcam Plc (ABCM) for $5.7 billion, including debt.

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

Mirxes, a Singapore-headquartered developer of RNA-based tests for the early detection of cancer and other diseases, said this week that it has recently signed two agreements that will help advance the company's commercial push into China and Indonesia.

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR).

Thermo Fisher Scientific said on Thursday that its Exent Solution, an automated mass spectrometry system for diagnosing patients with monoclonal gammopathies, including multiple myeloma, has been approved under Europe's In Vitro Diagnostics Regulation.

LumiraDx Limited (NASDAQ: LMDX), a next-generation point of care (POC) diagnostics company, today announced financial results for its second quarter ended June 30, 2023.

The Alzheimer’s disease blood test developer C2N Diagnostics has released a new version of its screener for beta amyloid proteins, and it’s gearing up for a nationwide rollout as public hopes rise for treatments that may make some headway against the condition.

Medtronic (MDT.N) on Tuesday raised its annual profit forecast as the return of non-urgent surgery volumes to pre-pandemic levels boosted demand for its medical devices, sending its shares up 3%.

Not long after acquiring Resolution Bioscience in a deal worth more than half a billion dollars, Agilent Technologies has resolved to shutter the business, which was developing liquid biopsy tests that were powered by next-generation sequencing technology and meant to be used as companion diagnostics for cancer patients.

Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union’s CE Mark approval.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.