Roche plans to release the system in the US to run tests including vitamin D and steroid assays under CLIA before it possibly receives US Food and Drug Administration clearance.
The organization is leveraging its growing bank of whole-slide pathology images to create models that could form the backbone of cancer testing applications.
The molecular test is used to differentiate bacterial infections, viral infections, and noninfectious disease and to assess the risk that patients will develop severe illness.
A reference measurement procedure incorporating digital PCR can potentially be used with rare and emerging pathogens to help labs compare qPCR results, researchers said.
Abbott Q4 Diagnostics Revenues up 4 Percent, Excluding COVID-19 Tests
The firm's Q4 2024 overall revenues were up 7 percent and full-year 2024 revenues were up 5 percent.
Roche Gets 510(k) Clearance, CLIA Waiver for Liat Triplex Point-of-Care STI Test
The point-of-care assay to detect and differentiate chlamydia, gonorrhea, and mycoplasma infections from a single sample will now be commercially available in the US in coming months.