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Improved patient access

The first personalized ctDNA test to inform adjuvant treatment decisions and detect recurrence earlier

When Is Signatera Used?

Our commitment is to improve patient access to personalized and tumor-informed testing to help guide treatment decisions. Signatera is a tool that allows physicians to stratify their patients, closely monitor the effectiveness of adjuvant therapy and detect early relapse better than conventional tools. Signatera is a custom-built and tumor informed molecular residual disease (MRD) assay used to inform the presence of circulating tumor DNA (ctDNA), enabling physicians to get in front of disease or provide patients with much-needed peace of mind.

Signatera Coverage

  • Risk Stratification
    After surgical resection to inform adjuvant treatment decisions
  • Recurrence monitoring
    To find early signs of cancer recurrence in patients with a previous cancer diagnosis
  • Therapeutic response
    To monitor the cancer’s response to treatment like immunotherapy (IO) on a molecular level

Natera accepts all commercial and public insurances

Signatera Medicare Coverage
  • Benefits include serial use of Signatera in patients with stages II/III colorectal cancer(CRC)1
  • Benefits also include single time point use for patients with stages II/III colorectal cancer(CRC)
  • Medicare patients with staged II/III CRC are fully covered, other indications are welcome however an ABN may be required*
  • Patients on immunotherapy will be covered for serial use of Signatera
Altera Medicare Coverage
Medicare patients diagnosed with solid tumors are fully covered if they meet one of these criteria:either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer, other stages are welcome however an ABN is required*
Please note, Altera testing is covered only if the Altera NGS test has not been previously ordered for the patient’s same primary diagnosis of cancer.
Commercial-coverage

Read more in our Billing Guide

Learn about insurance and billing guidance for Signatera and Altera testing.

Commercial-coverage

Compliance with Medicare Billing Rules

When providing services to Medicare beneficiaries, laboratories, including Natera, must adhere to billing regulations from the Centers for Medicare & Medicaid Services (CMS), including the “Date of Service” regulation (42 C.F.R. §414.510).

Reach out to Natera for support with coverage

Commercial-coverage

Commercial insurance

  • We welcome all insurance plans
  • We will work with patients so that cost is not a barrier for testing
  • We offer an affordable cash pay rate for those patients who do not wish to use insurance
Compassionate-care

Compassionate Care Program

If a patient is uninsured or is concerned about their ability to pay for testing, they can contact us at Tel:+1.650.489.9050 option 3 | oncologybilling@natera.com

At Natera, we understand that billing processes can be confusing

For questions or financial assistance, please contact Natera’s Patient Coordinators.

PHONE

650.489.9050



References

1Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131

2Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat. Cancer. 2020