The New York State Department of Health has granted conditional approval for use of the CombiSNP array for pediatric analysis on patient samples.
A chromosomal microarray analysis (CMA) test intended to identify development disorders in pediatric patients, the CombiSNP array for pediatric analysis is a product of CombiMatrix Corp, Irvine, Calif, a molecular diagnostics company performing DNA-based testing services for developmental disorders and cancer diagnostics.
In 2013, the New York State Department of Health granted CombiMatrix approval to market its CombiSNP CMA test for miscarriage analysis.
CMA testing for pediatric development disorders is recommended by the American College of Medical Genetics for individuals with developmental delays, birth defects, physical deformities, or autism or autism spectrum disorder. Such tests enable parents and physicians to determine whether the child’s abnormality is caused by a genetic defect. If so, the condition can be addressed in a number of ways, including watching for health conditions associated with the abnormality, providing eligibility for services such as speech or physical therapy, and evaluating the risk to future pregnancies.
Specializing in miscarriage analysis, prenatal healthcare, and pediatric healthcare, CombiMatrix provides valuable molecular diagnostic solutions and comprehensive clinical support. The company offers comprehensive testing services for the detection of gene abnormalities at the DNA level, beyond what can be identified through traditional technologies. The company performs genetic testing utilizing microarray, FISH, PCR, and G-Band chromosome analyses.
“Gaining the conditional license enables us to market and sell the CombiSNP array for pediatric development disorders throughout New York State,” said Mark McDonough, CEO of CombiMatrix. “We have focused our market development activities on our miscarriage analysis test over the past year, and now we plan to expand our activity to address pediatric disorders. Since last year, we have been selling directly to customers as well as through distribution partnerships. In the meantime, we look forward to working with the New York Department of Health to obtain full approval for this important test to assist patients and their physicians.”
Under conditional approval, CombiMatrix will be able to market the test in New York while the test is under Clinical Laboratory Reference System review. Upon completion of the review, either the test will receive full marketing approval or additional information will be required in order to achieve final approval.
For further information, visit CombiMatrix.