By Allison Proffitt 

June 3, 2014 | Pathway Genomics has launched its BRCATrue test for BRCA 1 and BRCA 2 and its BRCA One for One program, hoping to offer the industry’s best BRCA genetic test and make it accessible to a wide range of women. 

The company believes the One for One program to be rare in health care. "We thought a lot about it and we talked to a lot of global patient advocacy organizations and we thought... for every test that was ordered, we can donate a test to someone in need," Ardy Arianpour, Chief Strategy Officer for Pathway Genomics told Bio-IT World. 

Pathway is partnering with eight advocacy groups representing an international patient population: Susan G. Koman for the Cure, Bright Pink, Living Beyond Breast Cancer, National Ovarian Cancer Coalition, Young Survival Coalition, Foundation for Women's Cancer, Facing Our Risk of Cancer, and Sharsheret.

"The patient advocacy groups did tell us that a lot of people came to them saying, 'I don't have the money, but I want to get this testing... can you help us?'" Arianpour said. 

Pathway Genomics tests are ordered by and returned through a physician. Samples are gathered by the patient's doctor, and sequencing and analyses are done in Pathway's CLIA-certified labs. 

For every test ordered and paid for through a physician, Pathway will offer a test free of charge to advocacy organizations to distribute. "We're not picking and choosing [patients]," Arianpour said. "We want this to be an open access program."

The One for One program is limited to $10 million worth of free testing, and the BRCATrue test costs $1,799; that's almost 5,600 free BRCA tests. (Myriad Genetics' BRCA test costs about $3,000 to $4,000.)

The test itself—Pathway's BRCATrue test—took the company over a year to design, Arianpour says, and returns results within 14 calendar days. The saliva-based next-generation sequencing test and deletion/duplication analysis looks for mutations in both BRCA1 and BRCA2 and performs with a sensitivity of over 99.99%. "Our coverage on the BRCA gene is far greater than any other laboratory offering BRCA testing," he says. 

Arianpour says Pathway expects—and is prepared—to be "flooded with samples" from both ordering physicians and the One for One program. "Pathway has the capacity and scalability of running thousands of samples a day," he says, and relies heavily on robotics for sample handling. (The company currently runs thousands a week.) "We were built from the start to handles massive amounts of samples."  

Instead of a challenge, Arianpour sees the coming swell of samples as a boon to research for Pathway and the breast cancer community as a whole. 

"We're going to get some amazing data," he says. The wealth of data will be crucial for research and will help in "getting the lowest VUS [variants of unknown significance] rates." 

Arianpour says the company is happy to be able to offer testing to women who couldn't otherwise get it, and hopes the One for One program will provide an avenue for more testing internationally of traditionally underserved demographics. 

"It's not just about having some cheap price on a test. It's about doing as much testing as possible," Arianpour said. "We'll be able to do testing with the BRCA One for One program [for women] who have never been tested in certain demographics." 

As Pathway Genomics is active in the Free the Data movement, Arianpour said, the company will deposit its data in ClinVar. 

As with any mention of BRCA testing, Myriad Genetics and the company's gene patents immediately spring to mind. Arianpour declines to comment on the topic in general, but does offer a prepared statement about gene patents: 

"As you know, the viability and enforceability of patents relating to BRCA 1 and BRCA 2 testing have been in question for some time. In the last few years, we've seen the Supreme Court strike down a number of these patents. More recently, at least one district court has explicitly expressed its view that the validity of these patents will not withstand judicial scrutiny. As a company, we have taken a prudent approach to this matter, and we are confident that we do not infringe any valid claim."