Folate Receptor alpha (FRα): an actionable therapeutic target in platinum-resistant ovarian cancer
NeoGenomics is pleased to partner with ImmunoGen on a FOLR1 sponsored testing initiative called FR-ASSIST™, helping reduce barriers to immunohistochemistry (IHC) testing for novel biomarkers and aiding oncologists to make informed treatment decisions for their ovarian cancer patients.
FRα is an actionable target with the approval of ELAHERE™ (mirvetuximab soravtansine-gynx), a FDA-approved FRα—targeting antibody drug conjugate (ADC) for platinum-resistant ovarian cancer. 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 eligible for treatment with ELAHERE.
FR-ASSIST™ FOLR1 Ovarian Cancer IHC Testing Program
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.
Patient Eligibility Criteria:
Eligible patients may receive one (1) FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma test at no cost regardless of test results or treatment decision. 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
Please note the program does not cover any other costs, including, but not limited to, office fees and biopsy fees. FOLR1 will be made available broadly to prescribers without regard to prescribing volumes or other commercial considerations.
To enroll your patient in the FOLR1 IHC Testing Program, download the FOLR1 test request form.
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FAQ for Health Care Professionals
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.
With the approval of ELAHERE™ (mirvetuximab soravtansine-gynx), FRα is now an actionable target in platinum-resistant ovarian cancer.
Yes; NeoGenomics is validated to run the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the FDA-approved companion diagnostic for ELAHERE™. NeoGenomics provides this test under the name FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma.
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.
Yes; Fresh or archival ovarian cancer tissue is acceptable for FOLR1 IHC CDx testing.
The ordering health care provider must complete and sign the appropriate FOLR1 IHC CDx Test Request Form and submit it to NeoGenomics, or complete the information and attestation in NeoGenomics’ online ordering system. Completion of this form is required and submission also enrolls the patient in the Companion Diagnostic Testing Program.
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 NeoGenomics test requisition or create a new accession in online ordering.
NeoGenomics 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.
Results are typically ready in 48 hours from the time the specimen is received at NeoGenomics and will be sent to the ordering physician’s office or laboratory by their preferred method of delivery.
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 NeoGenomics Billing Department at 866-776-5907, option 2.
If you have questions about our testing process, please contact NeoGenomics Client Services at 866.776.5907 or client.services@neogenomics.com.
Further information about ELAHERE™ and FRα is available here.
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