June 16, 2014 | Ten days after Pathway Genomics announced its new BRCATrue test and its plan to donate $10 million worth of tests in its one for one program, Myriad Genetics filed a patent infringement suit against the company. While calling the suit "unwarranted", Jim Plante, Pathway Genomics' founder and CEO, also acknowledged that the lawsuit was "not unexpected. We do not infringe on any valid patent claims and are prepared to vigorously defend ourselves," Plante said in the company press release. Pathway's BRCATrue test is a 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%. Pathway Genomics' press release in response to the lawsuit.
In June 2013, the Supreme Court ruled
in the landmark case Association for Molecular Pathology v. Myriad Genetics
that naturally-occurring DNA is patent ineligible, but Myriad has continued to challenge aspects of patent infringement, and has filed suit
against several companies launching BRCA tests.