By Kirell Lakhman
Prenatal fetal genetic testing in the US will see "an enormous expansion … within the next five, and almost certainly 10 years" thanks to new technology advancements, according to a prominent Stanford law professor who specializes in the legal, ethical, and social issues surrounding the biosciences.
The professor, Hank Greely, said new genetic tests for conditions such as Down syndrome and cystic fibrosis will reverse a trend that has seen the use of genetic tests for these disorders decline in the US by half over the past 20 years.
The prediction is obviously good news for companies like Sequenom, which is staking its future on blood-based prenatal fetal diagnostics.
But why is a law professor dipping his toes into this area? According to Greely, if such tests are FDA-approved, "I believe every obstetrician in the country will quickly decide he or she has to offer it to every pregnant woman, because of legal standard of care issues." He mentioned other reasons — none of them surprising — during his talk, which he made at the Sadie Lewis Webb Lecture in Law and Biomedicine at the University of Virginia last week.
Incidentally, Sequenom's existing prenatal fetal tests — a fetal sex-determination test, a fetal RHD genotyping test, and a cystic fibrosis carrier screening test — are homebrews.
According to Greely, around 60,000 fetal genetic tests are currently performed each year in the US, which is down from 100,000 a decade ago and 120,000 20 years ago, according to the article.
He used the example of Medicaid reimbursement and Down syndrome, saying there are about 5,500 children born annually with the disorder. Greely said that considering Medicaid now pays for about 40 percent of all births in the US and decides to cover a genetic prenatal test for Downs, "it could be performed in as many as 3 million out of approximately 5 million pregnancies in the country each year, even accounting for women who opt not to have it," the article said.
Considering that "within a few years could cost as little as $1,000" that could be a potent revenue driver for companies that make such tests and clinical labs that perform them.