Italian in vitro diagnostics firm Diasorin said on Sunday that the US Food and Drug Administration has issued 510(k) clearance and CLIA-waived the firm's first assay for use on the Liaison Nes platform.

Results of a Phase I clinical trial published on Tuesday demonstrate that Personalis' minimal residual disease (MRD) assay, NeXT Personal, accurately predicts immunotherapy response across multiple metastatic solid tumor cancer types.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has categorized its Ionify® 25-Hydroxy Vitamin D total assay as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This represents the first time a mass spectrometry-based test has achieved this designation, opening access to a broader range of clinical laboratories.

Nuclein, a leader in rapid, point-of-care molecular diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System.

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.