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FDA submission

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.

The supplement adds a collection vial to the BD Onclarity test and includes performance data for the BD Viper LT and the BD COR Systems.

The Seattle-based firm believes its novel collection devices are convenient and safe enough to use at home to draw blood for many types of tests.

The company said the nanowire technology it has been developing to detect traumatic brain injury also has the potential to enable rapid testing for SARS-CoV-2 at the point of care.

The sequencing firm said infectious disease research, diagnostics, screening, and surveillance could all increase demand for its NGS products.

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