FDA clears high-volume slide scanner for Roche Digital Pathology Dx
February 2025—Roche’s whole slide imaging system, Roche Digital Pathology Dx, received an additional 510(k) clearance from the Food and Drug Administration. This latest clearance modifies the one Roche received in June 2024 for Roche Digital Pathology Dx, which includes the Ventana DP 200 slide scanner.
Roche says the now FDA-cleared Ventana DP 600 has 40 times the capacity of the Ventana DP 200 and uses the same scanning technology. Roche Digital Pathology Dx now includes the Ventana DP 200 and DP 600 slide scanners, Roche’s digital pathology workflow software, and a display.
Clearance for Liat STI assays
The Food and Drug Administration granted 510(k) clearance and CLIA waiver for Roche’s Cobas Liat sexually transmitted infection multiplex assay panels. They are tests for chlamydia and gonorrhea and for chlamydia, gonorrhea, and Mycoplasma genitalium and will be exclusively available in the U.S. market in the coming months. Roche says commercialization under CE mark will follow shortly.
New HER2-ultralow indication approved
The Food and Drug Administration approved a label expansion for the Roche Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify patients with hormone-receptor-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with Enhertu.
FDA clears test to aid in diagnosing B-cell lymphoma
Roche received 510(k) clearance from the Food and Drug Administration for its Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail. The test is designed to help differentiate a B-cell malignancy from a normal, reactive response to an infection.
The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail is a qualitative assay that is used to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed, paraffin-embedded human hematolymphoid specimens by in situ hybridization. It is intended as an aid in diagnosing mature B-cell lymphomas and plasma cell neoplasms.
FDA clears TriVerity
The Food and Drug Administration granted marketing authorization for the Inflammatix TriVerity test system for patients with suspected acute infection or sepsis. TriVerity combines bacterial-viral infection scoring with an all-cause illness severity risk evaluation.
The test system includes the TriVerity cartridge and the Myrna instrument. TriVerity incorporates a panel of 29 patient messenger RNAs to rapidly read immune response to infection using machine-learning-derived algorithms. TriVerity shows the likelihood of bacterial infection, viral infection, and illness severity in adult patients with suspected acute infection or sepsis who present to emergency departments.
The FDA cleared TriVerity based on the results of the Sepsis-Shield study of 1,222 enrolled patients across 22 sites. TriVerity was granted breakthrough device designation in 2023.