Guardant Health Japan Corp. (HQ: Minato-ku, Tokyo/ Representative Director: Mika Takaki), a leading precision oncology company, today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Guardant360® CDx as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) for consideration of treatment with amivantamab-vmjw combined with chemotherapy. This approval makes the Guardant360 CDx comprehensive genomic profiling panel the first blood-based companion diagnostic to be approved in Japan for the detection of EGFR exon 20 insertion mutations. Janssen Pharmaceutical K.K. (HQ: Chiyoda-ku, Tokyo/ Representative Director: Shuhei Sekiguchi), a Johnson & Johnson company, is currently seeking regulatory approval for the use of amivantamab-vmjw, a precision medicine, in Japan.

WHO has asked manufacturers of mpox in vitro diagnostics (IVDs) to submit an expression of interest for Emergency Use Listing (EUL). WHO has been in ongoing discussions with manufacturers about the need for effective diagnostics, particularly in low-income settings. The request for EUL expressions of interest by manufacturers is the latest development in these discussions.

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.