DOWNERS GROVE, Ill--Vysis, Inc. has received FDA clearance to market its CEP X SpectrumOrange/CEP Y SpectrumGreen DNA Probe Kit, an in vitro diagnostic used as an adjunct to standard cytogenetic analysis to identify and enumerate the presence of X and Y chromosomes in bone marrow specimens from patients who have received sex-mismatched bone marrow transplants.
The probe is used to assess the success of engraftment after transplant and to diagnose recurrence. CEP X/Y allows visualization of the sex chromosomes in a procedure that provides results in less than three hours, thus providing a presumptive diagnosis before standard cytogenetic analysis.
The approval is the company's third in two months for its in vitro diagnostic FISH probes for leukemia. The other products are the CEP 8 Spectrum-Orange DNA Probe Kit, used to detect trisomy 8, a key prognostic indicator for leukemia and other myeloid disorders, and the CEP 12 Spectrum-Orange DNA Probe Kit, used to detect trisomy 12, a common chromosomal alteration in CLL patients.