Skip to content

FDA allows marketing for first of-its-kind post-natal test to help diagnose developmental delays and intellectual disabilities in children

January 22, 2017

Today the U.S. Food and Drug Administration authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes. According to the National Institutes of Health and the American Academy of Pediatrics, two to three percent of children in the United States have some form of intellectual disability. Many intellectual and developmental disabilities, such as Down syndrome and DiGeorge syndrome, are associated with chromosomal variations.   The FDA reviewed the Affymetrix CytoScan Dx Assay through its de novo classification process, a regulatory pathway for some novel low-moderate-risk medical devices. For the de novo petition, the FDA’s review of the CytoScan Dx Assay included an analytical evaluation of the test’s ability to accurately detect numerous chromosomal variations of different types, sizes, and genome locations when compared to several analytically validated test methods.  The FDA found that the CytoScan Dx Assay could analyze a patient’s entire genome and adequately detect chromosome variations in regions of the genome associated with intellectual and developmental disabilities. Additionally, the agency’s review included a study that compared the performance of the CytoScan Dx Assay to tests that are commonly used for detecting chromosomal variations associated with a developmental delay or intellectual disability. A comparison of test results from 960 blood specimens showed the CytoScan Dx had improved ability over commonly used tests, including karyotyping and FISH chromosomal tests, to detect certain chromosomal abnormalities. This device should not be used for stand-alone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer. The test results should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate. Interpretation of test results is intended to be performed only by health care professionals who are board certified in clinical cytogenetics or molecular genetics. Affymetrix CytoScan Dx Assay is manufactured by Affymetrix, Inc., located in Santa Clara, Calif. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.  

Source: www.fda.gov

Advertisements

From → Scoop.it

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: