Ambry Genetics Will Vigorously Defend Against BRCA1 and BRCA2 Gene Patent Infringement Suit 

July 10, 2013

FOR IMMEDIATE RELEASE

Ambry Genetics
1 Enterprise
Aliso Viejo, CA 92656

Ambry Genetics Will Vigorously Defend Against BRCA1 and BRCA2 Gene Patent Infringement Suit

Aliso Viejo, Calif. – July 10, 2013 – Ambry Genetics announced today that it intends to vigorously defend itself against the patent infringement suit filed yesterday in the United States District Court for the District of Utah by Myriad Genetics, the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development LP, and Endorecherche, Inc. The complaint alleges that Ambry Genetics infringes on certain Myriad BRCA1 and BRCA2 patents by offering diagnostic BRCA1 and BRCA2 testing to women. 

Ambry Genetics began offering BRCA1 and BRCA2 diagnostic testing following the United States Supreme Court’s landmark June 13, 2013 decision in AMP et al v. Myriad Genetics, et al. That lawsuit was brought by a coalition of patients, physicians and health care groups to challenge Myriad’s patents directed at BRCA1 and BRCA2 genes. As alleged in that lawsuit, Myriad maintained a monopoly over diagnostic testing of BRCA1 and BRCA2 genes under the Myriad patents and threatened legal actions against entities that wished to provide BRCA1 and BRCA2 gene testing to women. Following a multi-year legal battle, the unanimous Supreme Court decision held that genomic sequences, whether isolated or not, may not be patented and declared invalid the Myriad BRCA1 and BRCA2 patent claims challenged in that suit.

“Ambry Genetics supports the Supreme Court’s decision and will vigorously defend its position,” said Charles Dunlop, Chief? Executive Officer of Ambry Genetics. “We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing and Ambry is fully committed to supporting our clients and patients moving forward.”

Ambry Genetics is the leader in hereditary cancer diagnostics. With the addition of BRCA1 and BRCA2 testing to its menu, Ambry Genetics now offers the most comprehensive germline cancer-testing menu in the industry, providing patients with the most accurate diagnosis currently available. Menu highlights include: BRCAplus, BreastNext, OvaNext, ColoNext, CancerNext and coming soon multi-gene NGS panels aimed to analyze genes implicated in hereditary renal, pancreatic and PGL-PCC cancers.

About Ambry Genetics®?Ambry Genetics is a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified commercial clinical laboratory with headquarters in Aliso Viejo, Orange County, California. Since its founding in 1999, it has become a leader in providing genetic services focused on clinical diagnostics and genomic services, particularly in sequencing and array services. Ambry has established a reputation for unparalleled service and for over a decade has been at the forefront of applying new technologies to the clinical molecular diagnostics market and to the advancement of ?disease research. To learn more about testing and services available through Ambry?Genetics, visit www.ambrygen.com.