LabGenomics USA has successfully acquired Integrated Molecular Diagnostics (IMD) CLIA labs, bringing the total number of its CLIA-certified labs in the U.S. to four. This acquisition strengthens LabGenomics’ strategic development and expands its diagnostic services nationwide, particularly in molecular technology.

Danaher Corporation (NYSE: DHR) ("Danaher"), a global science and technology innovator, announced the launch of two new Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP)-certified labs intended to accelerate the development of Companion Diagnostics (CDx) and Complementary Diagnostics (CoDx).

Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for Xpert® HCV, the only molecular test in the US to detect hepatitis C virus RNA directly from a human capillary whole blood (fingerstick) sample. The Xpert HCV test is performed on the GeneXpert Xpress System.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments).

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test. This clearance allows the test to be used with accuracy and convenience in home and medical facility settings with CLIA certificates of waiver. This achievement also reflects QuidelOrtho’s dedication to delivering effective testing solutions while highlighting ongoing efforts in research and development to enhance market competitiveness.

C-luminary Biotech was founded in 2018 and is headquartered in Chengdu, China, with a research and development center in Suzhou and industrial platforms in Sichuan and Hunan, is a professional enterprise engaged in the research, development, production, and sale of in vitro diagnostic products.

Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd today announced that they have entered into an agreement of Contract Development and Manufacturing Organization (CDMO) partnership for Cartridge based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121. Notably, the analyzers and reagents will be sold under Agappe’s brand, making Agappe the first Indian local company with a complete Chemiluminescence Solution comprising locally manufactured reagents.

Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Sansure Biotech has achieved a milestone in the field of immunodiagnostics, marking significant progress in international strategic expansion. On the evening of November 14, Sansure Biotech announced that its automated chemiluminescence immunoassay (CLIA) systems recently received the EU CE IVDR certification.

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted CLIA Waiver from the U.S. Food and Drug Administration (FDA), applying to its new Sofia® 2 SARS Antigen+ FIA.