First, on July 12, a US senator wrote a letter to the National Institutes of Health (NIH) that essentially sought to make sure that competition in BRCA testing flourishes and that the price of testing drops.
The goal of the letter by Sen. Patrick Leahy (D-VT) to Francis Collins, MD, PhD, director of the NIH, was to prod the federal government into taking action to "ensure access to affordable life-saving diagnostic tests for breast and ovarian cancer" according to a press statement.
Sen. Leahy urged the NIH to exercise an obscure federally mandated right to force Myriad "to license the patent on reasonable terms" to other parties because Myriad's patented products had originally been developed with federal funds. In other words, Sen. Leahy wants to optimize the number of American women who can access the test and he sees cost as a potential block to that aspiration.
The senator's letter came days after Myriad filed lawsuits against 2 companies that began offering BRCA testing at substantially lower costs. The suits allege that the competitors are infringing on specific Myriad patents that are distinct from those invalidated by the US Supreme Court in June, and that the competition is now unfairly forcing testing prices down, with the anticipated result that "Myriad will lose significant amounts of revenue."
One of the lawsuits is against Ambry Genetics (Aliso Viejo, California). A spokesperson for Ambry told Medscape Medical News that the lawsuit is without merit. "They have never had competition in their space," said Ardy Arianpour, MBA, senior vice president of business development at Ambry, about Myriad's motivations.
Myriad made its own timely announcement on July 15, also tackling the issue of BRCA testing cost and accessibility.
The company issued a press release describing its expanded financial assistance program for "qualified underinsured patients."
Myriad currently offers free testing to low-income women with no insurance, according to a press statement.
On its Web site, Myriad points out that most private insurers cover genetic testing and that the average patient pays a coinsurance of less than $100.
However, even though insurers generally pick up all or most of the tab for eligible women, the high cost is still there, said Jeffrey Rosenfeld, PhD, assistant professor of medicine at the University of Medicine and Dentistry of New Jersey in Newark. "One of the claims that Myriad had was that insurance would pay for testing," he said in an interview in June with Medscape Medical News. "The problem is that even if insurance is covering it, someone is still paying for it, and the money has to come from somewhere."