The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.
The FDA granted de novo classification for eight probes for detecting chromosomal rearrangements reported in acute myeloid leukemia and myelodysplastic syndromes.
Following FDA approval last October, Adaptive has now secured Medicare coverage for its NGS-based minimal residual disease assay, ClonoSeq.
With several SBIR grants from the NIH, the firm is also using its Liquid Scan platform to identify neonatal trophoblast cells in maternal blood samples.
Despite initial promise, NGS-based MRD detection has not been broadly adopted, but improvements in technology and more clinical utility data may change that.
Cellworks' technology predicted drug resistance in newly diagnosed patients with myelodysplastic syndromes.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
In granting de novo premarket authorization to ClonoSeq, the agency established its regulatory expectations for similar tests.
The firm expects to begin distributing shipments of its FTL3 assay from LabPMM GK, the marketing authorization holder in Japan, in late 2018.