Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
Several groups are comparing Bionano with standard cytogenetic assays like karyotyping, FISH, or array CGH for blood cancer or genetic disease testing.
The firm plans to add more oncology tests, NIPTs and newborn screening assays through in-house development and partnerships with third-party assay makers.
MolecularMD is expected to expand Icon's laboratory services by enabling it to better support precision medicine programs for drug-diagnostic codevelopment.
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.