The FDA granted de novo classification for eight probes for detecting chromosomal rearrangements reported in acute myeloid leukemia and myelodysplastic syndromes.
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.
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.
