The US Food and Drug Administration released on Monday its final rule to regulate laboratory-developed tests (LDTs).

Recently, Wondfo Biotech's wholly-owned subsidiary in the United States, Wondfo USA Co., Ltd. (hereinafter referred to as the " Wondfo USA"), received notification from the U.S. Food and Drug Administration (FDA) that the WELLlife™ COVID-19/Influenza A&B Test has been granted Emergency Use Authorization (EUA240004). The WELLlife™ COVID-19/Influenza A&B Test is designed for professional use at the point-of-care (POC) settings.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer’s disease on people and society.

Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox. The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.

Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.

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.

Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.

French diagnostics firm BioMérieux said Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its BioFire SpotFire Respiratory/Sore Throat (R/ST) test panel.

The US Food and Drug Administration announced last week that Roche's Cobas Malaria test has been approved by the agency.

Diagnostic test maker Technoclone on Tuesday said it has secured US Food and Drug Administration de novo marketing authorization for a test that is used to aid the diagnosis of a rare, life-threatening blood-clotting disorder.