We provide all necessary documents: patient informed consent to participate in the tumor profiling program; authorization and release of medical information forms; and laboratory test requisitions. We also provide a simple grant application for patients who need financial support.
A patient coordinator fills out most forms in collaboration with an oncology nurse. Physicians must sign laboratory requisitions. We coordinate the testing process with the pathology and testing labs. We currently collaborate with Foundation Medicine to perform the testing.
Results are generally available within two weeks after the labs receive the tumor specimen. Once testing is completed, we send a summary report. Clearity offers assistance or consultation to interpret the report and can work with physicians and patients to incorporate this data into the decision-making process. We can also help identify appropriate clinical trials.
Tumor profiling is most likely to help women who:
- Have been recently diagnosed with advanced (stage III or IV) cancer and their germline BRCA test is negative. Presence of a somatic BRCA gene mutation supports use of PARP inhibitor maintenance therapy.
- Have recently recurred or their cancer has progressed. Results from a recent specimen may be different from those obtained from older specimens. If a proximal tumor specimen is not available, we can arrange testing for a prior sample.
The test requires a standard formalin-fixed paraffin-embedded (FFPE) block. Some of the testing can also be performed on a cell pellet from peritoneal ascites fluid or a pleural effusion sample that is fixed in formalin and embedded in paraffin. The fluid samples should be processed within 30 minutes to be adequately preserved for this testing.
For biopsy specimens, a minimum of three core biopsies, aligned in an FFPE block, are required for analysis.
Clearity arranges for samples to be shipped from the pathology lab to the CLIA-certified testing facilities.
As a non-profit, Clearity’s services are free of charge. The costs associated with molecular testing can vary depending on the patient’s insurance. For patients who may need financial assistance to cover the cost of molecular testing, we offer a grant program to defray some or all of those costs.