Prostate Gene Panel Test Process
The 2018 NCCN guidelines call for testing all prostate cancer patients with Gleason score (GS) 8, 9, 10 or metastatic (METS) disease (regardless of family history); and patients with Gleason score 6 or 7 with a strong family history of cancer1 for germline mutations in BRCA and several other genes.
Once the patient is diagnosed with prostate cancer a pathology report showing a Gleason Score 8, 9, 10, Mets or a 6 or 7 with a strong family history is used to determine if the Gene Panel Test is needed. The Gene Panel is then run on the patients germline DNA samples to determine if hereditary mutations are present.
Strand’s Prostate Gene Panel Test includes testing for BRCA1, BRCA2, ATM and CHEK2, the relevant genes for guiding a prostate cancer treatment plan in accordance with the NCCN. If the test is positive for a pathogenic germline mutation, the patient will be directed to a genetic counselor to explain information regarding their specific mutation(s) and whether it is advisable to share that information with other family members and there is no cost for this consultation.
It is VERY EASY to order the Prostate Gene Panel Test from Strand because the know error® system biopsy kits already include buccal swabs for collecting the patient’s germline DNA; therefore, there is no need to call the patient back to provide another specimen, nor a need to order a special kit (such as with Myriad, Ambry or Color).
Just call 1-888-9Biopsy (924-6779), option 2 to get started.
What genes are tested in your panel?
The panel includes BRCA1, BRCA2, ATM, and CHEK22 which comprise the genes that are relevant for guiding prostate cancer treatment plan based on currently available data. In the event that new evidence becomes known, we may add additional genes to the panel as appropriate.
Will the patient get a bill? or Who pays for the test?
Medicare and commercial payers will be billed. Medicare patients will not be balanced billed. Commercially insured patients will receive a maximum bill from Strand of $95 should the insurance company not allow the claim, or in the event that all or part of the claim has been applied to a co-pay or deductible. In cases where Strand gets paid, Strand will accept the payment as payment in full. Medicare’s payment rate for this testing is about $2,300, but rates from commercial carriers vary widely.
Does the patient need to consent to the test?
Check with counsel, but many practices have consents that are all-inclusive to cover any test a physician may need to order to diagnose or treat a patient. We also have a specific consent form you may use if desired.
Are there test results on gene mutations that aren’t related to prostate cancer?
Reports from other labs are designed for broad cancer risk screening for those not diagnosed with cancer. Those reports examine many genes with no relevance to prostate cancer prognosis. In contrast, Strand’s Prostate Gene Panel report is designed specifically for Urologists to manage their prostate cancer patients, and we provide a concise 1-page result showing only the genes that have been shown to be relevant for the management of a patient’s prostate cancer. If there is a mutation, the patient will be directed to a genetic counselor to explain information regarding their specific mutation(s) and whether it is advisable to share that information with other family members. There is no cost for this consult. You can request to see a sample report by calling 1-888-9Biopsy (924-6779), option 2 or contacting us.
Does my practice need to collect family history of cancer?
Family history is not needed for a patient with Gleason 8, 9, 10 or METS. However, many practices obtain adequate family history to comply with insurance billing requirements. For those without adequate family history and with permission from the practice, Strand will reach out to the Gleason 6 or 7 patient seeking to complete the family history information and will provide it to the practice. (Family history is needed in order to determine whether it is appropriate to order germline testing on patients with a Gleason score of 6 or 7). For additional information on how Strand seeks to collect the patients complete the family history please call client services at 1-888-9Biopsy (924-6779), option 2.
Why should we order from Strand?
Besides being EASY, here are a few other reasons:
• Extremely accurate test results
• The only test that complies with CMS requirement that specimen contamination must be excluded from identified variants! All tests include DSPA (Strand’s DNA Specimen Provenance Assay). Confirms provenance and purity.
• Reports from other labs are designed for broad cancer risk screening for those not diagnosed with cancer. Those reports examine many genes with no relevance to prostate cancer prognosis. In contrast, our Prostate Gene Panel report is designed specifically for Urologists to manage their prostate cancer patients, and we provide a concise 1-page result showing only the genes that have been shown to be relevant for the management of a patient’s prostate cancer.
• Genetic counseling is provided at no charge to the patient that is positive for a pathogenic germline mutation.