Pathway Genomics Introduces Test That Focuses on Latino Community

Pathway Genomics has brought a new twist to the burgeoning BRCA testing market: An assay directed at the Latino community.

The San Diego-based laboratory has introduced a limited version of the BRCA assay that focuses on eight variants of the gene that are found specifically in Latino patients. The $399 assay is being called the BRCATrue Hispanic and will allow its users to project their risk of contracting breast or ovarian cancer. According to Pathway, the number of BRCA gene variants is higher than average among women of Latin-American/Hispanic descent.

Although Latinas have lower-than-average mortality rates from breast and ovarian cancer, their screening rates for such diseases are significantly below white women. Health policy experts have suggested the lower levels of health insurance in the Latino community are among the reasons for the disparity.

"The BRCATrue Hispanic (8-Site) test gives providers the option to test specific BRCA1 and BRCA2 pathogenic variants that are recurrent in the Mexican and Hispanic populations," said Pathway Genomics' Chief Commercial Officer Ardy Arianpour in a statement. "This targeted testing provides a more cost-effective testing option for individuals in these populations, and will allow for quicker delivery of results to patients and their providers."

The marketplace for BRCA testing has been extremely competitive since the U.S. Supreme Court ruled in 2013 that a patent could not be held on a single gene. That eliminated the BRCA testing monopoly for Utah-based Myriad Genetics, prompting many laboratories to offer the test at a fraction of the $4,000 Myriad charged. But the multitude of labs offering tests has also prompted some to seek new versions of the tests that can attract a specific audience in order to stand out.

Peter Francis, chief executive officer of Clinical Laboratory Sales Training, LLC, a Maryland-based consulting firm, said the Pathway test is the first assay he has seen that targets a specific ethnic group outside of Jews of eastern European descent. That group is vulnerable to genetic conditions such as Tay-Sachs and Fragile X Syndrome.

Although Francis said Pathway's price tag for the test is very competitive, he questioned whether the company would be able to market it to the Latino community to great effect. Pathway does not have extensive coverage with commercial insurers, he noted.

"I question the number of Hispanic patients that will be educated on/offered BRCA testing by a healthcare provider and able to afford the potential out-of-pocket expense of meeting a deductible or paying outright due to no insurance despite the test's relative low cost," he said in an email response. "Scientifically justifying the R&D expense to institute a terrific test is one thing; getting appropriately reimbursed for it sits on the other side of the equation."

Takeaway: Pathway Genomics is creating a new marketing niche in the burgeoning field of BRCA testing.