oday, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the latest results from an ongoing survey that ADLM has been conducting to determine how the Food and Drug Administration's (FDA's) final laboratory developed tests rule will impact patient care.

BioMérieux reported Thursday that its second quarter revenues rose 8 percent year over year due in part to strong sales of BioFire assays.

Foundation Medicine, Inc. today announced a collaboration with Syndax Pharmaceuticals (Nasdaq: SNDX) to develop a companion diagnostic for the identification of acute myeloid leukemia (AML) patients harboring an NPM1 mutation. As part of the collaboration, Syndax will also support Foundation Medicine’s efforts to pursue regulatory approval of an assay based on the FoundationOne®Heme platform.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has entered into a collaboration with Eli Lilly and Company to support the development of a QIAstat-Dx in-vitro diagnostic (IVD) to detect APOE genotypes which can play a role in the diagnosis of Alzheimer’s disease.

Colorectal cancer is a significant health concern in China, with high incidence and mortality rates. Research indicates that screening and early diagnosis, especially for high-risk groups, can significantly improve early detection and reduce mortality.

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, welcomes the European Court of Justice's (ECJ's) judgment today ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has completed the acquisition of Edwards Lifesciences' Critical Care product group, which will be renamed as BD Advanced Patient Monitoring.

In the process of enterprise development, both endogenous growth and external mergers and acquisitions are important growth paths.

Samsung Medison has announced the completion of its acquisition of the French startup Sonio, a move that underscores the company's commitment to integrating artificial intelligence (AI) into medical devices.

- Nature Awards MDx Impact Grants in partnership with Seegene extends commitment to external innovation. - Global research teams invited to submit proposals to develop new tests for human infectious diseases. Application deadline: December 2, 2024. - Nature Awards to lead the application and evaluation process. Projects selected in August 2025 based on clinical need. - A major investment in open innovation, the commercialization of multiplex PCR technology and availability of diagnostic tests.

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.