The Association for Molecular Pathology and Michael Laposata, a pathologist at the University of Texas Medical Branch-Galveston, have filed a lawsuit against the US Food and Drug Administration challenging the agency's May 6 final rule on laboratory-developed tests (LDTs).

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, 2024.

Finnish biotech startup Nadmed said on Thursday that it has raised €3.5 million ($3.9 million) in a Series A financing round.​

Roche Diagnostics Suzhou signed an investment agreement with the Suzhou Industrial Park Administrative Committee on Wednesday, announcing it would invest 3 billion yuan (US$420 million) to expand its existing site in Suzhou, Jiangsu Province.

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, and University Hospitals, one of the nation's leading nonprofit health systems and academic medical centers, today announced a definitive agreement for Quest to acquire select assets of University Hospitals' outreach laboratory services business.

Agilent Technologies Inc. (NYSE: A) today reported revenue of $1.58 billion for the third quarter ended July 31, 2024, a decline of 5.6% reported and 4.4% core(1) compared to the third quarter of 2023.

Chinese authorities have intensified efforts to prevent the import of the mpox virus as global cases continue to rise.

Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced the peer-reviewed publication of an analytical validation study of its EsoGuard® Esophageal DNA test for the diagnosis of esophageal precancer (Barrett's Esophagus or BE) and esophageal adenocarcinoma (EAC) on samples collected non-endoscopically using Lucid's EsoCheck® Esophageal Cell Collection Device. The manuscript, entitled Analytical Validation of a DNA Methylation Biomarker Test for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma from Samples Collected Using EsoCheck®, a Non-Endoscopic Esophageal Cell Collection Device, has been published in the peer-reviewed journal Diagnostics, and is currently available via open access online.

A prototype heart-failure screening device that measures levels of two biomarkers for heart failure in as little as 15 minutes from a drop of saliva is being presented at the American Chemical Society (ACS) hybrid fall meeting, which is being held virtually and in person in Denver August 18-22.

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

Burning Rock Biotech Limited (the ¡°Company¡± or ¡°Burning Rock¡±) announces that, on August 19, 2024, it intends to submit requests (a) to the London Stock Exchange (the ¡°LSE¡±), to cancel the admission to trading on the Main Market of its American Depositary Shares representing the class A ordinary shares of the Company (the ¡°ADSs¡±), and (b) to the UK Financial Conduct Authority, to cancel the listing of the ADSs on the Official List.

Informatics firm Genedata announced that it has been acquired by Danaher.

As an important reference for clinical diagnosis and treatment, high sensitivities and accuracies are very important for the control over the error of test results.

Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation. This certification recognizes Agendia¡¯s strict adherence to rigorous quality and safety standards and ensures the tests¡¯ reliability and effectiveness in clinical settings across the EU.

The US Food and Drug Administration announced on Friday that it has granted de novo marketing authorization to an over-the-counter test for syphilis antibodies manufactured by NowDiagnostics.