The analyzer is designed to provide extended differential and rapid C-reactive protein whole blood measurement.

The US Court of Appeals for the Federal Circuit remanded the case to the Patent Trial and Appeal Board to consider patent validity.

The agreement will enable Beijing-based RocGene to distribute its qPCR systems, reagents, and consumables in South Korea and to explore additional market strategies.

NEW YORK – The US Food and Drug Administration granted and updated 510(k) clearances for about a dozen assays, as well as software for digital pathology-based analyses, to end 2025. Among rapid tests ...

The company's full-year 2025 revenues rose 6 percent year over year, with a 4 percent decline in diagnostics for the year.

The autoimmune diagnostic company expects its new assay to be available by the end of this year or in early 2027.

The firm's benchtop TruVerus system can now run a total of 26 FDA-cleared assays in three modalities from a single blood collection tube.

In addition to pushing cuts off until the beginning of 2027, the bill would update the data collection period used to establish the 2027 lab rates from 2019 to 2025.

The company's full-year 2025 revenues rose 6 percent year over year, with a 4 percent decline in diagnostics for the year.

NEW YORK — The US Food and Drug Administration has issued warning letters to four direct-to-consumer health testing companies for selling unauthorized blood collection kits for HIV diagnosis.