Diagnostic for Chromosomal Disorders

A new prenatal diagnostic is designed to detect a broad range of aneuploid and deletion disorders.

The new bioassay is comprehensive, diagnosing major aneuploid disorders and three important deletion disorders (DiGeorge, Cri-du-Chat, and Williams-Beuren). The results of testing to date demonstrate 100% sensitivity and 100% specificity. Results are available within 24 hours. The assay, called 3D HydroArray, was developed by Biocept, Inc. (Carlsbad, CA, USA) and is based on the company's polyethylene glycol-based urethane hydrogel platform that is biocompatible and adaptable to a number of different bioassays. The current technical focus of the company is the development of 3D biochips for gene expression and protein analysis.

Guidelines from the American College of Obstetrics and Gynecology call for prenatal testing when there is an elevated risk of chromosomal disorders, which includes all pregnancies where the mother is over 35. While several screening and diagnostic methods are available for chromosomal disorders, Biocept states that they all have limitations, namely that the screening methods are not definitive because they only identify biomarkers of a potential problem. Also, existing diagnostic tests use invasive sample collection methods that carry a small risk of miscarriage or injury to the fetus, and karyotyping or fluorescence in situ hybridization (FISH) take 7-14 days to complete in most cases.




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