IG Laboratories Inc. said Monday it will begin marketing aprenatal test that can detect chromosomal abnormalitiesresponsible for 95 percent of birth defects within 48 hoursafter amniocentesis.
About 300,000 prenatal tests are performed annually in theUnited States, with the parents having to wait seven to 10 daysfor the results. Some 152,000 babies each year are at risk forgenetic abnormalities, said IG Labs spokeswoman DonnaLaVoie. Of these, 15,000 babies are actually born with birthdefects.
IG Labs' Insight Rapid Chromosome Analysis uses DNA probesthat bind to five key chromosomes in cell nuclei that areresponsible for most birth defects: 21, 13, 18, X and Y. Theprobes, which contain a fluorescent marker, bind to the targetDNA sequences. The fluorescent markers can be read under aspecial microscope to see if the normal number ofchromosomes are present. Defects usually occur when threechromosomes are present rather than two.
In traditional amniocentesis, fetal cells are cultured and thegenetic material is separated and rearranged to create a chartof all 46 chromosomes for analysis.
The Insight test, which will cost between $135 and $165,depending on the region of the country, will be sold inconjunction with the traditional test, which IG Labs alsomanufactures. That test costs between $450 and $600. About60,000 Insight tests will be administered each year to womenin high-risk categories and those in later stages of pregnancy,said LaVoie. That would generate between $8 million and $10million in sales.
IG Labs of Framingham, Mass., is a wholly owned subsidiary ofGenzyme Corp. of Cambridge, Mass. Genzyme stock(NASDAQ:GENZ) closed Monday at $34.38, up $1.
-- Karen Bernstein BioWorld Staff
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