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New Releases: Dec 22, 2010

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Myriad Genetics this week launched Panexia, a test that analyzes the PALB2 and BRCA2 genes to predict a person's risk of developing hereditary pancreatic and related cancers.

This is the company's ninth commercially launched product. "Panexia promises to provide healthcare providers, patients and their families with a better understanding of not only their pancreatic cancer risk, but possibly their breast, ovarian, or other related cancer risks," Mark Capone, president of Myriad Genetics Laboratories, said in a statement.

Myriad has set the list price for Panexia at $3,025. The company said that it has started training its 300-plus sales force in anticipation of accepting patient samples for the test at the start of next year.

According to the American Cancer Society, more than 43,000 people are diagnosed with pancreatic cancer in the US each year, but usually the disease is caught in later stages and therefore, patients usually have poor outcomes. As a result, the ACS estimates that nearly 37,000 people will die from pancreatic cancer this year.

Myriad is hoping that the launch of Panexia will have a positive impact on patient outcomes, since more than 20 percent of pancreatic cancer cases may have a familial component, and PALB2 and BRCA2 are the most commonly identified genes in families affected by pancreatic cancer. According to Myriad, those with a mutation detectable by Panexia have up to an 8.6-fold higher risk than the general population of developing pancreatic cancer.

"If an individual with a family history of pancreatic cancer receives the Panexia test and is identified as having a deleterious mutation, increased surveillance and other steps can be taken in an effort to detect the cancer at an early stage where it may be more treatable," Myriad said in a statement.

Currently, surgical removal of the tumor is best available option for patients with early-stage pancreatic cancer whose disease has not metastasized to other organs. However, surgical removal is not appropriately used in the majority of pancreatic cancer patients since only between 15 percent and 20 percent of all pancreatic cancer is caught early enough.

According to Myriad, since families impacted by pancreatic cancer also suffer from related cancers, this might provide an avenue for selling more tests. For example, if testing with Panexia indicates that a person has an increased hereditary risk of pancreatic cancer, and the pateint's family history also shows a pattern for other types of cancer, this might justify follow-on testing with many of the other tests in Myriad's portfolio.

"The occurrence of pancreatic cancer in combination with other cancers in families such as breast, colon, melanoma, ovarian and endometrial cancer, may point to other inherited cancer predisposition syndromes for which additional genetic testing may be appropriate," the company said in a statement, noting that it also sells a test for gauging predisposition to hereditary breast/ovarian cancer (BRACAnalysis), hereditary colon/endometrial cancer or colon polyps (Colaris and Colaris AP), and hereditary melanoma (Melaris).

Myriad announced last year that it had obtained from Johns Hopkins University an exclusive, worldwide license to intellectual property covering mutations in the PALB2 gene that have been shown to confer an increased risk for pancreatic cancer (PGx Reporter 10/21/09).

The PALB2 gene mutations and their association with pancreatic cancer susceptibility were identified by researchers at Hopkins' Sol Goldman Pancreatic Cancer Research Center. The inventors have filed two applications pending with the World Intellectual Property Office: "Pathways Underlying Pancreatic Tumorigenesis and an Hereditary Pancreatic Cancer Gene," and "Diagnostic Method Using PALB2."

Myriad has also said it also holds exclusive rights under 10 issued US patents covering p16 and BRCA2 gene mutations linked to pancreatic cancer.

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