FOLR1 Ovarian Cancer Testing Program
Folate Receptor alpha (FRα): an actionable therapeutic target in platinum-resistant ovarian cancer
To support physicians in determining FRα expression in their ovarian cancer patients, ImmunoGen is providing a sponsored, no-charge, third-party IHC testing program for patients with a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer.
PathAI Diagnostics is excited to collaborate with ImmunoGen on an initiative known as FR-ASSIST™, a sponsored testing program for FOLR1. This program aims to streamline immunohistochemistry (IHC) testing, and reduce obstacles for the testing of novel biomarkers, all while aiding oncologists to make the most informed treatment decisions for their ovarian cancer patients.
Folate receptor alpha (FRα) is an actionable biomarker that is important to assess in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. ELAHERE™ (mirvetuximab soravtansine-gynx) is the first and only treatment indicated for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC), who have received one to three prior systemic treatment regimens. It is important to test all ovarian cancer patients for FRα expression.
The FRα protein is expressed in 90% of ovarian cancers and has limited expression in normal tissue, making it an attractive therapeutic target. When using the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay for the evaluation of ovarian cancer patients, approximately 35% of patients are considered to have high expression of FRα— defined as ≥75% tumor cells staining at 2+/3+ intensity— and thus may be eligible for treatment with ELAHERE™.
Eligible patients may receive one (1) FOLR1 FDA for Ovarian Carcinoma test at no cost regardless of test results or treatment decision.
Patient Eligibility Criteria
Patients must meet all of the following criteria to be eligible:
Patient has ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer)
- Patient lives and receives treatment in the United States or a US Territory
- Patient does not have a known FRα expression from a previous test
- Patient has not previously been tested under this Program
To enroll your patient in the FOLR1 IHC Testing Program, download the FOLR1 test request form.
FAQs for Healthcare Professionals
What role does folate receptor alpha (FRα) play in ovarian cancer?
Folate receptor alpha (FRα) is an actionable therapeutic target that is commonly expressed in ovarian cancer. Approximately 35% of ovarian cancer patients are expected to be positive for FRα expression by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
Why should I test for folate receptor alpha (FRα) in my ovarian cancer cases?
With the approval of ELAHERE™ (mirvetuximab soravtansine-gynx), FRα is now an actionable target in platinum-resistant ovarian cancer.
Is this the companion diagnostic test for ELAHERE™ (mirvetuximab soravtansine-gynx)?
Yes; PathAI Diagnostics is validated to run the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the FDA-approved companion diagnostic for ELAHERE™. PathAI Diagnostics provides this test under the name FOLR1-CDx (Ovarian Cancer).
Who should get tested for FOLR1 protein expression (also known as FRα)?
The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is intended for use in the assessment of FRα in ovarian cancer, including epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer. Because FRα is generally stable through the course of treatment, testing can be done upon diagnosis of ovarian cancer or at progression.
Can I use archival ovarian cancer tissue for testing?
Yes; Fresh or archival ovarian cancer tissue is acceptable for FOLR1 IHC CDx testing.
How do I order the test?
The ordering health care provider must complete and sign the appropriate FOLR1 IHC CDx Test Request Form and submit it to PathAI Diagnostics, or through their Foundation Medicine representative. Completion of this form is required.
The Test Request Form is available here. If tests in addition to the FOLR1 IHC CDx are required on the submitted tissue specimen, please also complete a separate standard, printed PathAI Diagnostics test requisition.
What are the specimen requirements for tissue?
PathAI Diagnostics offers FOLR1 IHC CDx testing on formalin-fixed paraffin-embedded (FFPE) tumor resection or biopsy samples. Ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer and primary fallopian tube cancer) tissue is required. The paraffin block is preferred. Alternatively, send One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns). Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives or send decalcified specimens.
When can I expect the results?
Results are typically ready in 48 hours from the time the specimen is received at PathAI Diagnostics and will be sent to the ordering physician’s office or laboratory by their preferred method of delivery.
What if I get a bill?
No patient, health care program, or beneficiary shall be billed for this test as part of the testing program. If you should receive a bill, please contact the PathAI Diagnostics Billing Department at 888-276-7956 or [email protected]