Aprogenex Inc. announced Thursday that it has submitted a510(k) premarket notification with FDA for its GenSite HbFprobe assay, which detects fetal hemoglobin (HbF) messengerRNA.
This is the first part of an assay Aprogenex is developing toidentify and enumerate chromosomal abnormalities in fetalcells circulating in maternal blood. The HbF probe assay detectsfetal cells, which Aprogenex's vice president of finance, DonaldPayne, said are difficult to differentiate from maternalnucleated cells.
The second part of the GenSite prenatal genetic testing assayutilizes DNA probes to analyze chromosomes and determine thegender of the child and whether there are geneticabnormalities.
The third component is an enrichment process that makes iteasier to find fetal cells. Payne explained that with this processone fetal cell in 1,000 could be detected rather than one in 10million. The final assay will combine these three elements.Aprogenex (ASE:APG) of Houston expects to complete trials onthe assay and submit a final set of filings to FDA by the end ofthe summer.
Aprogenex said the GenSite assay is "designed to permit thediagnosis of up to 95 percent of prenatal genetic abnormalities,mitigating the need for more invasive prenatal genetic testingprocedures such as amniocentesis or chorionic villus sampling."Genzyme Corp. and CellPro Inc. are in preclinical trials withsimilar assays. -- Brenda Sandburg
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