Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. Screening for HPV can help identify women who are at risk of developing cervical cancer so that the disease can be found and treated early before cervical cancer has a chance to develop.

The US Food and Drug Administration (FDA) has warned users not to use Cue Health’s at-home Covid-19 tests, just one week after the agency issued a warning letter saying that Cue was not following the conditions specified in the emergency use authorisations for its tests.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use.

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

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.