The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry.

Biocartis Group of Companies (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ CDx MSI Test developed in partnership with Bristol Myers Squibb, has received the first-ever Premarket Approval (PMA) from the FDA for a cartridge-based, fully automated, “sample-to-result” companion diagnostic test.

AliveDx said Tuesday that it has registered its multiplex immunoassay analyzer for autoimmune disease and allergy testing with the US Food and Drug Administration as a Class II device that is exempt from premarket authorization requirements.

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling.

Agilent Technologies Inc. (NYSE: A) today announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer. This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo® (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy® (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

From January 2024 and June 2025, the U.S. Food and Drug Administration (FDA) approved 39 in-vitro toxicology testing products through the 510(k). This period marked a significant reshaping of the global market: Chinese companies, driven by rapid product iteration and precise market positioning, surged in the market share. At the same time, the worsening fentanyl crisis in the U.S. fueled an unprecedented demand for fentanyl testing, making it the most competitive and dynamic segment in the field.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection of the amyloid plaques associated with the disease in appropriate patients. Developed by Fujirebio Diagnostics, Inc., the test is now available nationwide through Labcorp.

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) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the addition of Anterior Nasal Swab (ANS) as a validated specimen type for this panel, specifically for use with the respiratory test menu. By swabbing only the anterior part of the nasal cavity, ANS provides significantly more comfort for the patient.

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

Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI Prostate, establishing it as the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer.