PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that its AISightⓇ Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis.

QuidelOrtho announced Thursday that its Vitros syphilis assay has received 510(k) clearance from the US Food and Drug Administration and is now available globally.

Hitachi High-Tech Corporation ("Hitachi High-Tech") and Gencurix, Inc. ("Gencurix") have entered a strategic partnership (the Partnership) in the field of cancer molecular diagnostics.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the expansion of its Master Collaboration Agreement with AstraZeneca to develop and commercialize companion diagnostics (CDx) for AstraZeneca¡¯s future therapies being developed to address chronic diseases.

According to recent monitoring data, China recorded 1,060,600 new cases of lung cancer in 2022, accounting for 22% of all malignant tumors.

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test and its first two companion diagnostic (CDx) indications.

Building a complete biochemical testing system is the future development trend in the biochemical industry.

Siemens Healthineers aims to grow its PET imaging business by picking up the radiodiagnostic manufacturing and distribution network of Novartis¡¯ Advanced Accelerator Applications division.

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced the completion of its acquisition of LifeLabs from OMERS. The transaction, valued at approximately CAN $1.35 billion (approximately USD $1 billion), including net debt, has received all necessary approvals and is now closed.

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

On August 22, 2024, the China Association of In-Vitro Diagnostics (CAIVD) welcomed a delegation from the Korea In Vitro Diagnostics Association (KIVDA) for a strategic visit aimed at strengthening collaboration between the two nations¡¯ IVD industries.

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.