The team will present the results to the US Food and Drug Administration as part of a 510(k) application in order to commercialize the technology with Biofluidica.
The FDA granted de novo classification for eight probes for detecting chromosomal rearrangements reported in acute myeloid leukemia and myelodysplastic syndromes.
The probes are for use in Cancer Genetics' FISH-based HPV-Associated Cancer Test, which measures genomic changes to help triage cervical cancer patients.
The assay correlates shortened telomere lengths in patients of different ages to potential risks for inherited diseases, such as bone marrow failure syndrome and liver cancer.
Angle aims to show that clinicians can determine HER-2 status by subjecting harvested circulating tumor cells to fluorescence in situ hybridization (FISH).
