FDA submission
Biocartis Files FDA Submission for Microsatellite Instability Test in Colorectal Cancer
The assay is intended to detect
Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib
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.
Startup Angstrom Bio Plans Saliva-Based COVID-19 Nucleic Acid Test on Nanopore Sequencing Platform
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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.
Angle Files De Novo FDA Submission for CTC Collection Device in Breast Cancer
The submission data highlights Parsortix's ability to harvest circulating tumor cells from metastatic breast cancer patient blood samples for downstream analysis.Â
Sep 25, 2020
May 29, 2020
May 13, 2020
Feb 20, 2020
FDA Releases List of Evidence-Based PGx Variants
Jan 14, 2020
BioMérieux Submits 43-Target BCID2 Test to FDA
Jul 1, 2019