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FDA submission

The DRP would be used to identify kidney cancer patients likely to benefit from dovitinib, a repurposed TKI for which Allarity plans to file an NDA this year.

The test runs on the firm's Curian rapid fluorescent immunoassay and detects four species of a common foodborne pathogen.

The firm said that a US FDA clearance would broaden the adoption of its growing portfolio of diagnostic assays for Alzheimer's disease.

The firm said that its test uses cerebral spinal fluid to produce a numerical ratio of β-Amyloid1-42/ β-Amyloid1-40, and runs on its fully automated Lumipulse G1200 instrument system.

Angstrom Bio is developing a rapid, scalable coronavirus test that uses nanopore sequencing to detect barcoded PCR products.

Adaptive is rebranding its immunoSeq Dx assay as T-Detect and plans to submit for an EUA for a COVID-19 T-Cell response test by the end of the year.

If approved, the kit would enable automated sample preparation for the company's T-SPOT.TB test using blood samples stored up to 54 hours at room temperature.

The submission data highlights Parsortix's ability to harvest circulating tumor cells from metastatic breast cancer patient blood samples for downstream analysis. 

The submission follows a clinical validation study of the test that analyzed data from samples collected from 400 US and Canadian patients with advanced HR+ breast cancer. 

The firm said that the shortage of testing in rural America highlights a need for its rapid molecular system, which is small enough to fit in a backpack.

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