Molecular test detects mutations in PALB2 and BRCA2, which increases risk 8.6 times.
Myriad Genetics launched Panexia™, a predictive test for hereditary pancreatic and related cancers. Panexia analyzes the PALB2 and BRCA2 genes, and a person with a detectable mutation has up to an 8.6-fold higher risk than the general population of developing the disease.
Pancreatic cancer affected more than 43,000 men and women in the U.S. this year, the American Cancer Society estimates. Approximately 37,000 people will die of pancreatic cancer in 2010, making it the fourth leading cause of cancer deaths among adults, according to the organization.
More than 20% of pancreatic cancer cases have been reported to have a familial component, Myriad Genetics reports. PALB2 and BRCA2 are the genes most commonly identified in the subset of families with pancreatic cancer.
Panexia is Myriad’s ninth molecular diagnostic product and the second to be launched this year. In March the company released Prolaris, a 46-gene prognostic test that quantitatively determines the risk of prostate cancer recurrence in patients who have undergone prostatectomy surgery.
The firm also offers testing for hereditary breast and ovarian cancers (BRACAnalysis), hereditary colon/endometrial cancer or colon polyps (Colaris and COLARIS AP), hereditary melanoma (Melaris), PTEN gene (PreZeon), exposure to 5-FU chemotherapy (OnDose), and toxicity to 5-FU chemo (TheraGuide).
Earlier this month Myriad took over technology from Melanoma Diagnostics that uses validated genetic markers for the diagnosis and prognosis of malignant melanoma. It expects to develop products for the differential diagnosis of melanoma from otherwise benign moles and for understanding the aggressiveness of the patient’s disease. Resulting tests will complement Melaris.
Myriad Genetics is currently appealing the decision made in March by the District Court in the Southern District of New York, which ruled that the patents the company holds on BRCA1 and 2 are invalid. In May 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) filed a lawsuit against the company, the University of Utah Research Foundation, and the USPTO.
It challenged the USPTO’s authority to issue patents that relate to products of nature as well as the legitimacy of claims issued to Myriad Genetics that relate to isolated DNA encoding the breast cancer markers BRCA1 and BRCA2 and to methods of detecting alterations in BRCA1 gene sequence to diagnose cancer. In November the U.S. Justice Department filed a friend-of-the-court brief, supporting the ACLU and PUBPAT.