HOUSTON and SALT LAKE CITY, Feb. 7, 2014 (GLOBE NEWSWIRE) -- Gene by Gene, Ltd. and Myriad Genetics, Inc., the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche, Inc., and the Trustees of the University of Pennsylvania (the "Patent Owners") have reached an agreement to settle the patent infringement lawsuit between them regarding BRCA testing.
Under the agreement and effective immediately, Gene by Gene will cease selling or marketing clinical diagnostic tests within North America that include analysis of the BRCA1 and/or BRCA2 genes as a standalone test or in conjunction with gene panels, but Gene by Gene will continue to offer such tests outside of North America. The Parties have also agreed that Gene by Gene may continue to offer its whole genome and exome products and services, which include the BRCA genes, as well as Gene by Gene's custom array products that test variants for inherited Mendelian disorders, including variants for BRCA1 and BRCA2, worldwide.
The agreement will continue until the earlier of February 12, 2016 or the last-to-expire valid patent claim in any of the BRCA patents involved in the case. In return, the Patent Owners have agreed to dismiss the patent infringement case against Gene by Gene without prejudice.
This settlement effectively ends the suit that was filed July 10, 2013, in which the Patent Owners alleged that the testing process employed by Gene by Gene infringes certain claims in patents owned by the Patent Owners covering synthetic DNA and methods-of-use related to the BRCA1 and BRCA2 genes.
About Gene by Gene
Founded in 2000, Gene By Gene, Ltd . ( www.genebygene.com ) provides reliable DNA testing to a wide range of consumer and institutional customers through its four divisions focusing on ancestry, health, research and paternity. Through its CAP Certified clinical-health division it offers regulated clinical diagnostic tests as well as Research Use Only (RUO) division serving both direct-to-consumer and institutional clients worldwide. Additionally, it provides DNA tests through its FamilyTreeDNA.com division, which pioneered the concept of direct-to-consumer testing in the field of genetic genealogy more than a decade ago and is the leader in the field. The privately held company is headquartered in Houston, which is also home to its state-of-the-art molecular CAP accredited Genomics Research Center.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com .
Myriad and the Myriad logo are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the scope, effect and duration of the settlement agreement entered into by Gene by Gene and the Company; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
Media Contact (Myriad): Ron Rogers (801) 584-3065 Investor Contact: Scott Gleason (801) 584-1143 Media Contact (Gene by Gene):
