Knowing early if there are traces of cancer present in your body can help you and your doctor or oncologist decide:
Signatera is a personalized assay created in a lab using tissue from your cancer and optimized to detect circulating tumor DNA (ctDNA) in your blood. Fragments of the cancer’s DNA can be found by running a sample of your blood through the assay which detects molecular residual disease (MRD), thereby offering broad utility for cancer management. The most common uses are as follows: (1) to monitor for recurrence/MRD after cancer treatment, (2) to help decide whether or not to pursue additional treatment such as chemotherapy, and (3) to help monitor response to ongoing therapies, whether neoadjuvant chemotherapy, immunotherapy, or stage IV cancer treatments.
Signatera is a cancer surveillance test uniquely personalized for each patient. This custom-designed test uses your cancer cells (obtained from the pathology slides) to determine a unique set of tumor mutations that belong to your cancer. A blood sample from you is then taken and analyzed for the presence of any of these mutations. If present (a “positive” result), this information allows you to know earlier that your cancer is likely to recur or has progressed during treatment. These results, positive or negative, can help you have a more informed discussion with your doctor on how to continue to treat your cancer.
Altera is a test commonly referred to as comprehensive genomic profiling (CGP). Altera tests a number of treatment agents against your tumor, using the tumor block and slides obtained from your cancer. You will receive a personalized report of which agents successfully kill cells from your tumor. Your doctor can then use this information to determine which treatments are best for your cancer. Altera prioritizes potentially beneficial therapies based on your tumor’s biomarkers and cancer type, and provides full details on known cancer driver genes as well as less common biomarkers.
The detailed sequencing report includes FDA-approved treatments, novel treatment approaches and ongoing clinical trials targeting found mutations. FDA-approved treatments for patient-specific genomic targets are provided, as well as novel approaches to detected targets when standard of care is exhausted. In addition, you will receive a list of clinical trials recruiting for detected genomic targets.
Altera can be performed on all invasive solid tumors. Altera cannot be performed on blood cancers at this time.
A physician must order Signatera. Our medical group, Pink Lotus Medical (“PLM”), is authorized to order Signatera for you via this website (order form available below), or you can schedule an appointment with your own physician to see if he/she can order Signatera for you. PLM gathers all information necessary and will complete and submit a requisition form and all ancillary patient data to Natera to order the Signatera test for you. The one-time processing fee for the administrative service is $149; which includes recurring orders for repeat testing for a total of two years. The interval between tests will depend on your cancer stage, how long it’s been since your diagnosis, the reason(s) for testing and what therapies you are currently receiving. After two years, you will have an option to continue testing if desired. PLM also orders Altera on all samples in addition to Signatera. There is no additional charge for Altera.
MRD is the presence of small traces of cancer in the blood, such as circulating tumor DNA (ctDNA) or microscopic pieces of tumor DNA.
A physician must order Signatera (we can provide this service for you so an appointment with your physician is not necessary). Once ordered, your custom-built assay will get created from your cancer slides. Once we have gathered and provided all the necessary patient information, a representative from Natera will contact you to arrange a blood draw. You can: (1) ask for a mobile phlebotomist (a person who draws blood) to come to your home to draw blood for the test at no additional cost to you, or (2) you can get your blood drawn at various Natera-approved labs, or (3) blood can be drawn in your physician’s office, if they agree to do so.
The first time the Signatera test is ordered, your custom-built assay needs to be created from your cancer slides. Once built, this assay can be used forever. It will take two weeks to design your personalized test from the date the tumor tissue is received at Natera. Once your blood is drawn, it will take approximately one week for your test results to become available to your physician if your doctor orders the test, or directly to you via a secure link if PLM orders your test (see above, Ordering Signatera). So, four weeks after a physician orders the test, you should have results.
Subsequent Signatera test results will become available to your physician or to you via PLM one to two weeks after your blood sample is received by the Natera laboratory.
In order to determine the unique genetic changes in your tumor cells only, we first have to know the DNA you were born with. The blood sample allows us to know the normal DNA sequence you inherited from your parents. The tissue sample allows us to look at the DNA from your tumor cells. By comparing the two, we can then determine which genetic changes are only occurring in your tumor cells.
If you have early-stage cancer, a negative test means that you are more likely to remain cancer-free. Once you test repeatedly negative for two years, there is a 3% chance of your cancer ever recurring. A positive test means that ctDNA was identified in your blood, and there is a 97% chance that your cancer is going to recur either where it first was detected (for example, in your breast if you had breast cancer), or metastatic (for example, in lymph nodes, lung, liver, bone, or brain). On average, this recurrence will occur 9.5 months from the time of the test.
Depending on your cancer stage and where you are in your treatment, the time interval for testing your blood for ctDNA varies. Your ordering physician will determine the testing interval that is best for you.
Signatera can detect extremely small amounts of tumor DNA before cancer recurrence can be seen by traditional imaging tools such as CT scans or MRI. The Signatera test is highly sensitive; this means that if your test result is positive, there is a high likelihood that your cancer may recur without further treatment.
Patients can cancel testing anytime up until the sample is received in the lab. To cancel an order, contact Natera directly:
Phone: 650.489.9050
Fax: 650.412.1962
Email: [email protected]
However, please note that our $149 administrative processing fee for providing the proper forms and documents to Natera is not refunded to you if you decide to cancel your test.
Coverage for Colorectal Cancer (CRC)
Effective October 18, 2020, CMS Molecular Diagnostics Program has finalized a local coverage determination (LCD) to provide Medicare benefits for the serial use of the Signatera molecular residual disease (MRD) test in patients with stage II or III colorectal cancer (CRC).
Coverage for Cancer and Immunotherapy
CMS has also issued a draft LCD to provide expanded coverage for Signatera to detect molecular residual disease in patients with a history of cancer to monitor immunotherapy (IO) response.
Coverage for Cancers Outside of CRC and Immunotherapy
There is variable coverage for Signatera based on your individual insurance plan. If insurance denies the test, there will be no out of pocket charges to you. If insurance covers the test, then you will be responsible for the deductible and co-pay assigned to you by your insurance benefits.
If you do not have insurance, affordable cash rates are available. If you are underinsured or unable to pay for testing, you can contact Natera’s Patient Coordinators to discuss their Compassionate Care Program.
Signatera Patient Coordinators will work with the patient’s insurance provider to file appeals and pursue coverage on the patient’s behalf.
A Patient Coordinator will reach out and contact the patient regarding coverage and potential out of pockets costs.
For more information about Signatera or to review published studies, visit www.natera.com/signatera
Pregnancy: Unfortunately at this time, Signatera cannot be performed in patients who are pregnant, however, this is not a contraindication for Altera (yes Altera can be performed in pregnant patients).
Donor bone marrow/stem cell transplants: No, neither Signatera nor Altera can be performed in patients with a history of donor bone marrow or stem cell transplant.
Organ Transplant: If the donor organ received is impacted by cancer (i.e. the tumor tissue being sent for testing derived from the donated organ), neither Signatera nor Altera, can be performed. However, if the patient happened to have had a transplant BUT the donated organ is NOT involved in the cancer diagnosis, then we can perform Signatera and/or Altera.
Receiving a COVID-19 vaccine does not make you ineligible for Altera and/or Signatera testing. You are eligible to proceed with testing if you have received or plan to receive the COVID-19 vaccine.
To order Signatera, please complete the form below. If you don’t have some of the required information handy, you can save the form and continue here later once you have located the missing information (your saved form is available for 30 days). Your personal and health information on this form is securely encrypted and protected by the latest in cloud-based firewall technology.
Please Note: it is highly encouraged that you upload pathology reports from every single sample of your tumor and/or metastatic sites that have ever been biopsied or excised (removed). Sometimes, the DNA is of poor quality or insufficient quantity such that the test cannot be created; in those instances, Natera needs to request a different cancer sample from a different date. If additional pathology reports are needed but you did not upload them with this form, an additional administrative processing fee of $50 will apply.