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).
Through the new lab, NeoGenomics can work with pharmaceutical clients through the different phases of drug development, including the development of companion diagnostics.
The acquisition allows Sysmex to enter the cytogenetics market and strengthens its technology base in molecular genetics, while expanding its life science business.
