Affymetrix Inc. Receives FDA Approval for Disabilities Tests

The medical technology company Affymetrix Inc. has just received approval from the U.S. Food and Drug Administration to market its procedure in order to help diagnose disabilities in children.

According to marketwatch.com, the CytoScan Dx Assay, a blood test, is designed to help diagnosis children's developmental and intellectual abilities via postnatal detection through DNA copy number variants found in patients. The organization notes that the product will be available in U.S. laboratories in the next few weeks.

"This clearance is first-of-its-kind, and represents a leap forward in molecular genetic testing," Affymetrix Chief Executive Frank Witney said, via the organization.

As it's estimated that two to three percent of children in the U.S. deal with some form of developmental delay or intellectual disability, this and other products that the company may offer could be tremendously beneficial in diagnosing a health issue early.

Health and Beauty News also notes that cystic fibrosis and sickle cell anemia are two more conditions that can be discovered and potentially treated early via the new blood test.

As it's estimated that 30,000 children and adults in the United States suffer from cystic fibrosis-an inherited chronic disease the affects the lungs and digestive system, and 90,000 to 100,000 Americans suffer from the genetic blood disease sickle cell anemia, these tests may prove particularly beneficial in providing early and life-saving treatments. 

"This assay represents the best option for accelerating an accurate diagnosis," of disabilities in children, said Alka Chaubey, director of the Cytogenetics Laboratory.