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 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 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 you can get your blood drawn at various Natera-approved labs.

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]

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.