In a potentially major advance in diagnosing autism spectrum disorder, San Diego's Pediatric Bioscience is preparing to sell a blood test later this year that would detect risk of one of its most common forms
The company's test detects antibodies in a woman’s blood that can cause what it calls “maternal autoantibody-related” autism, which the company says, based on clinical studies, represents 23 percent of all autism cases.
The test delivers a false positive response just 1.3 percent of the time, said Jan D’Alvise, the company's president and chief executive.
A positive test in mothers of infants or young children could expedite referral for assessment, she said. Also, if given before a planned pregnancy, the test could help women decide whether they should turn to parenting alternatives such as surrogate pregnancy or adoption.
Children of those who test positive would be sent to a specialist for a final diagnosis, expediting therapy.
Pediatric Bioscience plans to start selling the test in the third quarter of this year, D'Alvise said at the Biotech Showcase conference in San Francisco, an annual meeting of biotech investors and companies held concurrently with the JP Morgan Healthcare Conference. The company is now raising funds for that launch.
The test will cost about $1,000, and the company will partially subsidize the test for the women who aren't able to pay. Insurers are expected to reimburse for the test once they're familiar with it and have received recommendations from clinicians.
The market for such a screening method could be worth $1.8 billion annually, D’Alvise said.As a previous post noted, however, there are serious scientific questions about this blood test.
And testing of the mother's blood also raises the specter of abortion.