Hologic, Inc. (Nasdaq: HOLX) announced today that its Aptima® HPV Assay received FDA approval for clinician-collected HPV primary screening. Hologic’s human papillomavirus (HPV) test is the only FDA-approved mRNA-based assay, designed specifically to detect infections most likely to lead to cervical cancer.

Diasorin (FTSE MIB: DIA) announced today it has secured U.S. Food and Drug Administration (FDA) De Novo authorization for the first fully automated diagnostic test for hepatitis delta virus (HDV) on the Diasorin LIAISON XL immunoassay system. Designated as a Breakthrough Device by the FDA, the test aids in the diagnosis of HDV in individuals living with acute and chronic hepatitis B virus (HBV). The development of the automated diagnostic assay has been supported by Gilead Sciences.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic to identify patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab and chemotherapy in accordance with the approved product labeling.

Truvian Health (“Truvian”), a diagnostics company redefining routine blood testing, today announced U.S. Food and Drug Administration (FDA) clearance for the Complete Blood Count (CBC) on its TruVerus™ multi‑modal blood testing system (K251249).

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the EnCor EnCompass™ Breast Biopsy and Tissue Removal System, a state-of-the-art multi-modality breast biopsy system designed to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease.

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.

Applied BioCode said on Monday that is has submitted a new nucleic acid extraction claim for its BioCode Respiratory Pathogen Panel (RPP) to the US Food and Drug Administration, with the goal of expanding use of the panel by clinical laboratories.

Roche said Monday that the US Food and Drug Administration has approved the company's Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and Ventana HER2 Dual ISH DNA Probe Cocktail tests, clearing them for identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with AstraZeneca's Enhertu (trastuzumab deruxtecan).

The US Food and Drug Administration's recent proposal to reclassify companion diagnostic assays as Class Il devices may lead to additional opportunities for diagnostic test manufacturers, diagnostic industry stakeholders claim.

Swedish diagnostics firm Devyser said Thursday that its next-generation sequencing-based test for stem cell transplantation monitoring has received regulatory approval in Canada.