FR-ASSIST™ FOLR1 IHC Sponsored Testing Program

The FR-ASSIST™ Sponsored Testing Program is an ImmunoGen-sponsored program offering FOLR1 IHC testing at no cost to eligible patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer (US-based only). ImmunoGen covers the cost of the test for eligible patients regardless of test results and/or any subsequent treatment decision(s) made by the patient’s health care provider.

Any patient who meets the following criteria:

• Patient has epithelial ovarian cancer, fallopian tube or primary peritoneal 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
• Patient’s physician has determined that the test is clinically appropriate for the individual patient

Patients meeting the above eligibility criteria, as well as their treating health care providers, are not required to order, purchase, prescribe, and/or obtain any other product or service from ImmunoGen, Labcorp or any of their affiliates. 

All eligible patients who enroll in the FR-ASSIST™ Sponsored Testing Program will receive one 
FOLR1 IHC test (test code 453027) at no charge. 

Please e-mail Labcorp Oncology Client Services at [email protected] to set up a new account.  Please provide your name, contact information, along with your facility name and address.  An account is necessary to process orders and results for testing under the FR-ASSIST™ Sponsored Testing Program, but there are no requirements for health care providers to order or purchase any additional testing services from Labcorp Oncology or any of its affiliates. 

FOLR1 expression is largely restricted to malignant tumors compared to normal tissue and is commonly expressed in epithelial ovarian cancer (EOC).¹   Consequently, FOLR1 expression serves as an actionable biomarker in patients with EOC.  Approximately 35% of patients with EOC have high levels of FOLR1 expression (≥75% tumor cells staining at 2+/3+ intensity) and may be eligible for treatment with ELAHERE.²       
 

Yes, VENTANA FOLR1 RxDx Assay is a qualitative immunohistochemistry assay that has been validated by Labcorp Oncology in the assessment of FOLR1 expression. It is an FDA-approved companion diagnostic test for ELAHERE.     
 

Any patient with epithelial ovarian cancer, fallopian tube or primary peritoneal cancer who may be eligible for FOLR1-targeted treatment with ELAHERE should be tested. The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is the first and only immunohistochemistry (IHC) assay that is FDA approved to identify tumors with FOLR1 expression. Because expression remains relatively unchanged following chemotherapy, FOLR1 can be tested upon diagnosis or at progression.^2,3  

The FOLR1 IHC test is performed on formalin-fixed paraffin-embedded (FFPE) tissue.  One paraffin block (preferred) or five unstained slides sectioned at 4-5 microns, no more than 45 days in age, may be submitted.  

Results will be delivered to the ordering physician via their established reporting method within 2-3 days after the sample is received.

No, repeat testing is not included. Patients with a prior negative result are not eligible to receive additional testing through this program (see program eligibility criteria).

Click on the Contact Us button, provide a few details in the intake form about your practice and a Program Representative will be in touch with you shortly to provide specifics on how to order the test and receive supplies.  As part of the ordering process, physicians will complete a test request form confirming that the patient meets the eligibility criteria and that the testing is clinical appropriate for the individual patient.

Yes. We can procure the sample block from the designated pathology laboratory indicated in the completed test request form.

No.  The program is open to any patients who meet the eligibility criteria, regardless of their health insurance status.  No patients, providers, and/or third-party payers (including commercial health plans and government health care programs) will be billed for the FOLR1 testing covered under the program. 

The FOLR1 IHC test will be provided at no cost to eligible patients under the program.  The program does not cover the costs of any other tests, sample collection/processing fees, treatments, procedures, or medical services provided to the patient. 

If you have questions about the program, please contact Client Services at 800.447.5816 or e-mail at [email protected].