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Application to FDA for Approval of Olaparib to Treat Ovarian Cancer

AstraZeneca Pharmaceuticals has filed a new drug application for olaparib (a PARP inhibitor) capsules as maintenance treatment of patients with platinum-sensitive relapsed ovarian cancer who have completed chemotherapy. FORCE is strongly in favor of FDA approval and has presented testimony at the FDA's Oncologic Drugs Advisory Committee Hearing. (ODAC). Read more...

Updated Response to USPSTF draft guidelines on BRCA testing

The United States Preventive Services Task Force (USPSTF) is a panel of experts in prevention and evidence-based medicine which conducts scientific reviews of and develops recommendations on the effectiveness of a broad range of preventive services.

The USPSTF updated their guidelines for BRCA testing and published a draft of their proposed guidelines. FORCE submitted a response to this draft. Read more...

Myriad Genetics patent infringement lawsuit and preliminary injunction against Ambry and Gene by Gene

In June, the US Supreme Court invalidated Myriad's patents on the BRCA1 and BRCA2 genes. Since then, laboratories Ambry Genetics and Gene by Gene began offering genetic tests for BRCA mutations at a lower cost than Myriad. In July, Myriad sued both companies, alleging their BRCA tests infringe on patents not invalidated by the Supreme Court decision. Myriad has asked the court to block Ambry and Gene by Gene from BRCA testing until the patent infringement case is resolved. Read more...

Gene patenting lawsuit against Myriad Genetics

In a unanimously ruling, The United States Supreme Court invalidated Myriad Genetics' patents on the BRCA1 and BRCA2 genes. FORCE filed an amicus brief (friend of the court) in favor of the lawsuit and testified to the United States Patent and Trademark Office about the heavy burden that exclusive gene patents place on the hereditary cancer community. Read more...

Testimony to USPTO on impact of exclusive gene patents

FORCE testified to the United States Patent and Trademark Office (USPTO) on the adverse impact that exclusive gene patents has had on hereditary cancer research, interpretation of BRCA testing, and access to care. Read more...

FDA's Patient-Focused Drug Development Program

The FDA's Prescription Drug User Fee Act (PDUFA) authorizes the FDA to choose 20 different disease areas for concentration to expedite drug development and review. The FDA's preliminary list of 20 diseases does not include hereditary cancer syndromes.

FORCE in partnership with advocacy groups provided written and oral testimony to the FDA urging them to add inherited cancer syndromes to the disease focus list. The FDA is allowing public commentary on this issue until midnight on November 1, 2012. Read more...


Page updated 08/31/13

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