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December 01, 2015 1:57 PM ET

Healthcare Providers and Services

Company Overview of Ambry Genetics Corp.

Company Overview

Ambry Genetics Corp. provides clinical diagnostics testing services for genetic diseases. It offers gene sequence analysis for cystic fibrosis; and customizable sequencing, genotyping, and microarray services. The company also provides clinical resources that support ongoing clinician education and sharing of data to promote scientific discoveries that help in improving patient management and care. It serves physicians, genetic counselors, and patients. Ambry Genetics Corp. was founded in 1999 and is based in Aliso Viejo, California.

15 Argonaut

Aliso Viejo, CA 92656

United States

Founded in 1999





Key Executives for Ambry Genetics Corp.

Founder, Chairman of The Board of Directors and Chief Executive Officer
President and Chief Commercial Officer
General Counsel
Director of Clinical Affairs
Compensation as of Fiscal Year 2015.

Ambry Genetics Corp. Key Developments

Ambry Genetics Announces Newly Published Data on Hereditary Ovarian Cancer and Multi-Gene Panels

Ambry Genetics announced newly published data on hereditary cancer multi-gene panels, in Gynecologic Oncology. Published in collaboration with physicians at the University of Arizona, Hereditary Predisposition to Ovarian Cancer, Looking Beyond BRCA1/BRCA2, highlights important data regarding the role of multi-gene panels in diagnosing hereditary breast and ovarian cancer. This study analyzed data from 911 BRCA1/2-negative women with a history of breast and/or ovarian cancer who underwent testing with OvaNext, a multi-gene panel which currently includes 23 genes associated with hereditary breast, ovarian, and other cancers. Among the key findings, the authors identified an overall mutation rate of 7.4%, doubling the diagnostic yield compared to the expected mutation rate of 5-10% from BRCA1/2 mutation testing alone in similar cohorts. This article presents early data regarding moderate penetrance hereditary breast and ovarian cancer genes in a breast and ovarian cancer cohort. Among the ovarian cancer-only cohort, 26% of the mutations identified were in BRIP1 and 19% were in MSH6. Conversely, in the breast cancer-only cohort, the greater percentage of mutations were in CHEK2, ATM, and TP53 (34%, 11%, and 11%, respectively), with only 4% of mutations in BRIP1 inbreast cancer-only probands. Additionally, data presented in this article demonstrate that testing guidelines for known syndromes, such as Lynch syndrome, are not sufficient to detect all carriers of mutations predisposing to known hereditary cancer syndromes among cohort of patients, providing additional support for multi-gene panel based testing as opposed to phenotype-driven single gene testing.

Ambry Genetics Announces Settlement in BRCA1 and BRCA2 Gene Patent Infringement Case

Ambry Genetics announced a settlement agreement that ends the BRCA1 and BRCA2 gene patent infringement litigation against Ambry that began on July 9, 2013. The case is University of Utah Research Foundation, Ambry Genetics Corporation, United States District for the District of Utah, Case No. 2:13-cv-00640-RJS. Under this agreement the plaintiffs, including Myriad Genetics, the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development LP, and Endorecherche Inc. and Ambry agree to dismiss with prejudice their respective claims and counterclaims against one another in the BRCA1 and BRCA2 genepatent infringement litigation. Additionally, the Patent Owners grant a covenant to not sue Ambry under the patents asserted in the litigation proceedings. The decision to settle occurs after the United States Court of Appeals for the Federal Circuit held on December 17, 2014 that claims from three of the patents covering DNA-based BRCA1 and BRCA2 tests Myriad was asserting against Ambry did not contain subject matter eligible for patent protection.

Ambry Genetics Publishes Data Supporting Use of Hereditary Cancer Panel Testing

Ambry Genetics announced the publication of the highly anticipated results on the first 2,000 patients tested, in the journal Genetics in Medicine, supporting the clinical adoption of multigene cancer panels in the diagnosis of hereditary cancer predisposition. The study evaluated the first 2,079 patients who underwent Ambry's hereditary cancer multigene panel testing. Tests included a comprehensive analysis of 14-22 cancer susceptibility genes based on the panel ordered (BreastNext, OvaNext, ColoNext or CancerNext). This study identified positive test results in up to 9.6% of patients, with the majority of positive results correlating with clinical histories in affected patients. Interestingly, 30% of ColoNext patients with mutations in genes with well-established diagnostic criteria did not meet clinical criteria for the corresponding hereditary condition and would have eluded diagnosis by conventional methodologies. Results from this study point to an important role for targeted multigene panels in diagnosing hereditary cancer predisposition, particularly for patients with clinical histories spanning several possible diagnoses and for patients with suspicious clinical histories not meeting diagnostic criteria for a specific hereditary cancer syndrome.

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