Foundation Medicine Receives FDA Approval of FoundationFocus™ CDxBRCA as a Companion Diagnostic for Rubraca™ (rucaparib) for the Treatment of Women with Ovarian Cancer
--First and only companion diagnostic to detect tumor BRCA1/2 alterations, potentially increasing the number of women who are eligible for Rubraca (rucaparib) therapy--
Rubraca is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies, and selected for therapy based on an
"These simultaneous approvals by the
As part of the company's effort to develop a universal companion diagnostic, earlier this year,
More than 22,000 women will potentially be diagnosed with ovarian cancer in the
About FoundationFocus CDxBRCA
Intended Use: FoundationFocus CDxBRCA is a next generation sequencing test for qualitative detection of BRCA1 and BRCA2 (BRCA1/2) alterations in formalin-fixed paraffin-embedded (FFPE) ovarian tumor tissue. The FoundationFocus CDxBRCA assay detects sequence alterations in BRCA1/2 genes. Results of the test are used as an aid in identifying ovarian cancer patients for whom treatment with Rubraca™ (rucaparib) is being considered. If a patient is positive for any of the deleterious alterations specified in the BRCA1/2 classification, the patient may be eligible for treatment with Rubraca. This assay is to be performed at
Foundation Medicine® and FoundationOne® are registered trademarks and FoundationFocus™ is a trademark of
Cautionary Note Regarding Forward-Looking Statements for
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding any benefits of FoundationFocusCDxBRCA for women with advanced ovarian cancer; the ability of FoundationFocusCDxBRCA to identify more women who could benefit from PARP inhibitor therapy as compared to conventional testing methods that only identify germline BRCA1/2 mutations; the scope and timing of any approval of FoundationOne as a medical device by the
i Hennessy BTJ, et al. Somatic mutations in BRCA1 and BRCA2 could expand the number of patients that benefit from poly (ADP ribose) polymerase inhibitors in ovarian cancer. JCO. 2010;28(22):3570-6.
ii Pennington KP, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas.
News Provided by Acquire Media