NEW YORK (GenomeWeb) – Good Start Genetics announced that couples planning to have children can now purchase its VeriYou next-generation sequencing-based carrier screening test for cystic fibrosis and spinal muscular atrophy through Amazon.
"Despite widespread clinical availability of carrier testing, too few couples are getting screened today to promote a healthy pregnancy," said Good Start Genetics CEO Jeffrey Luber in a statement. "By bringing clinical-grade NGS testing to Amazon for $149, we believe we can vastly improve awareness, access, and broaden the adoption of carrier screening for millions of couples starting a family."
If both partners carry a variant for a specific condition, that means their child will have a 25 percent chance of carrying two copies and being born with the disorder.
Good Start Genetics said it is the first genetic testing firm to establish a direct partnership with Amazon to provide physician-ordered testing — other test providers with products on Amazon are selling through third parties. "With Amazon's analytics and information engine, we have the opportunity to bring the right test to the right individual at the right time — a key promise of personalized medicine," Luber said.
Individuals considering having children and interested in the test can register online, provide consent, and submit family history information. After that, a licensed physician will review the information and order the test, "if appropriate," the company said. After the company delivers results online, customers can ask physicians and genetic counselors follow up questions.
In its statement, Good Start Genetics highlighted recommendations from the American Congress of Obstetricians and Gynecologists that all women of reproductive age have the option of getting tested for CF variants. The American College of Medical Genetics and Genomics also recommends screening for CF and SMA.
The company also compared VeriYou to 23andMe's service, noting that VeriYou "tests for 20 times more CF variants than the leading consumer genetics company (591 CF variants compared to 28 variants)."
In 2015, the US Food and Drug Administration approved 23andMe's de novo 510(k) submission for its Bloom syndrome carrier screening test, determining that carrier screening tests were Class II devices, would not require premarket review, and could be offered directly to consumers.
In a Federal Register notice, the agency subsequently outlined how labs might go about legally commercializing a range of carrier screening tests that are 510(k) exempt, meaning such tests wouldn't require premarket notification, though they'd have to meet special controls or requirements. In the same notice, however, the FDA noted that it considers CF tests Class II devices that are subject to premarket notification and special controls.
In addition to the Amazon offering, Good Start Genetics also offers testing to a number of fertility centers for various genetic disorders, performs novel variant detection, and provides genetic counseling services.