Genzyme Molecular Oncology licenses colon cancer diagnostic patent rights.

Genzyme Molecular Oncology (Framingham, MA; 617-761-8419) announced it has entered into three licensing agreements that provide non-exclusive access to its colon cancer diagnostic patent rights related to the MSH2 and APC genes. Mutations in either of these genes indicate increased risk for developing certain colon cancers.

Quest Diagnostics, Inc., Mayo Medical Laboratories (Rochester, MN), and SRL, Inc., have been granted non-exclusive colon cancer diagnostic rights to the APC and/or MSH2 gene for use in diagnostic testing services that detect increased risk for certain colon cancers. Under each of the three agreements, Genzyme Molecular Oncology received an up front license fee and will receive royalties on each diagnostic test performed. Further financial details were not disclosed.

"These three agreements further increase our cancer diagnostic licensee base which already includes Affymetrix, Myriad Genetics, LabCorp, and EXACT Laboratories," said Gail Maderis, president, Genzyme Molecular Oncology. "We expect the interest in cancer diagnostics to grow as additional data from the Human Genome Project is analyzed and as more molecular therapeutics reach clinical and commercial development."

Genzyme has an extensive portfolio of intellectual property related to cancer gene diagnostics based on the work of its collaborators, Drs. Kenneth Kinzler and Bert Vogelstein at The Johns Hopkins University (Baltimore, MD). Genzyme Molecular Oncology is out-licensing its diagnostic rights to generate funds to help support its internal cancer therapeutic development efforts.

Under separate license agreements with Genzyme Molecular Oncology, Quest Diagnostics and SRL of Tokyo, Japan each intend to perform colon cancer genetic testing services that detect mutations in the MSH2 gene. These mutations, in conjunction with a family history of colon cancer, indicate increased risk for developing hereditary non-polyposis colon cancer.

Additionally, Quest Diagnostics, Mayo Medical Laboratories and SRL have licensed non-exclusive diagnostic rights to the APC gene. Mutations in the APC gene, when accompanied by increased polyps in the patient and a family history of colon cancer, indicate increased risk of developing familial adenomatous polyposis (FAP) colon cancer. The United States Food and Drug Administration has recently approved a therapy to treat FAP.

According to the American Cancer Society, colon cancer is the leading cause of cancer death among non-smoking men and women in the United States, with 130,000 new cases and 56,000 deaths projected annually. Approximately 25 percent of all colon cancer cases are triggered by a genetic predisposition to the disease.

Early detection of colon cancer or colon cancer risk offers physicians and patients a significant advantage in the management and treatment of the disease. Physicians can prescribe subsequent testing of family members, early colon cancer surveillance, detection and removal of polyps, and in some cases prophylactic surgery to help manage the disease. As medicine advances, more drugs are also becoming available to treat colon cancer.