Immunoscore For Patients with Colon Cancer

Immunoscore® is the only diagnostic test that assesses the immune system’s ability to defend itself against tumor cells. Immunoscore® can help your medical team develop an optimized treatment plan that balances benefits and risks by providing a clear and accurate answer about your risk of relapse.

Giving your medical team critical information to optimize your treatment plan

Before the development of Immunoscore®, physicians would rely on three factors—referred to as T, N, and M—to evaluate the risk of relapse:

  • T—how much the tumor (T) has spread within the affected organ
  • N—whether the cancer has spread to the lymph nodes (N)
  • M—whether the cancer has spread to a different part of the body with metastases (M)

However, this approach fails to account for the important role of the immune system in evaluating the risk of recurrence.

IMMUNOSCORE® gives your medical team a more accurate way to evaluate your risk of relapse by assessing your immune response at the tumor site.

Learn about the immune system and cancer in the Patient & Caregiver brochure.

Understanding your IMMUNOSCORE®

There are two types of Immunoscore® results: High and Low

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Immune system low

If your Immunoscore® is High then your risk of relapse is Low.

A high Immunoscore® indicates that your immune system is present in and around your tumor, which reduces your risk of recurrence.

immune system

If your Immunoscore® is Low then your risk of relapse is High.

A low Immunoscore® indicates that your immune system is present in and around your tumor, which increases your risk of recurrence.

How your IMMUNOSCORE® affects treatment decisions

If your cancer is stage II

Your tumor is localized. Based on the TNM classification and other clinical parameters, your doctor will opt for either surgery alone, or surgery followed by chemotherapy. Immunoscore® provides information to better assess your risk profile and determine the best personalized treatment strategy.

If your cancer is stage III

Your cancer is more advanced, and you will need to be treated with chemotherapy. Immunoscore® will help your doctor determine the most appropriate duration of chemotherapy for your situation.

Discussing IMMUNOSCORE® for Colon Cancer with your oncologist

If your oncologist is not familiar with Immunoscore®, he may have questions about the test. Here are a few facts about Immunoscore® that they may like to know:

  • Immunoscore® is for use with localized Stage II and Stage III colon cancer
  • Immunoscore® is included in the European Society for Medical Oncologists (ESMO) 2020 Clinical Practice Guidelines for Diagnosis, Treatment and Follow-up of Colon Cancer
  • Immunoscore® has been validated in an international study conducted on more than 2,500 Stage I-III colon cancer patients[1]. This study showed that Immunoscore® is a powerful and independent prognostic factor for patient survival which provided the greatest contribution to patient prognostication of all assessed factors.
Discussing IMMUNOSCORE®with oncologist@2x
Reduction in chemotherapy use with Immunoscore

Reduction in Chemotherapy Use with IMMUNOSCORE®

Among high-risk patients, 70% of patients have an Immunoscore High and may be spared from chemotherapy.
In Stage III colon cancer, where FOLFOX treatment ranges from 3 to 6 months duration, around 50% of patients have no significant benefit of extended FOLFOX treatment beyond 3 months.

References
  1. Pagès F, et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139.

Frequently Asked Questions

Immunoscore® is validated for localized colon cancer worldwide and is also available outside the United States for locally advanced rectal cancer (LARC) through our Innovation Access Program.

For localized Colon cancer, in combination with standard clinicopathologic features, the Immunoscore® result is indicated as an aid to determine the risk of recurrence and to adjust adjuvant chemotherapy decision-making for patients with early-stage colon cancer.

Immunoscore® must be prescribed by the oncologist managing your treatment. They will be able to determine whether Immunoscore® is an appropriate test for your situation. Once the test is ordered, the Veracyte team will work with your medical team to obtain the necessary tissue samples and ship them to our pathology laboratory.

We will return the results of your test to your doctor in less than 10 days after the sample reaches our facility.

“I was at home analyzing the statistical findings, and suddenly I noticed that the response of the patient's immune system really did play a key role. The data made it quite clear, the higher the number of immune cells, the better the life expectancy.”

Jérôme Galon, PhD

Inventor of IMMUNOSCORE®

When and How to Get an Immunoscore

After your surgery, a tissue sample from your tumor is preserved for further testing. When your doctor orders Immunoscore®, the pathology laboratory will send a portion of this sample to the Veracyte laboratory to perform the test. The results will be returned to the ordering practitioner for discussion of the results.

No additional medical procedures are needed to get an Immunoscore® test.

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Interested in ordering A test?

We have different programs available. Please Contact us for further information

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    Immunoscore® may not be covered by insurance payers.

    However, Veracyte accepts most insurance plans, including Medicare. We will perform the services ordered and deemed medically necessary by the physician regardless of your network status.
    Veracyte will file insurance claims for services provided on your behalf, including appeals for denied claims. Therefore, at the time the order is submitted, all necessary health insurance information and signed ABN and/or AOB are required for each patient.

    Patient Responsibility

    Patients are financially responsible for any deductibles, co-payments, and/or co-insurances deemed as patient responsibility in accordance with federal and state regulations and the patient’s individual insurance plan.
    We offer payment plans, which allow those who are unable to pay their full balance by the due date, to make monthly installment payments.

    Financial Assistance

    We are committed to providing Immunoscore® testing regardless of your ability to pay. Through our -Financial Assistance Program, we have tailored solutions for uninsured or underinsured patients based on individual circumstances. We may adjust some or all laboratory charges if you cannot afford to pay for your testing

    You can contact the Billing department via email at billing@haliodx.com or call our Toll-free number (833) 293-0101.

    To apply for our Financial Assistance Program, please download the application here.
    Fill out the information and fax it with the supporting documents to the following number: (804) 944-2759 or email to billing@haliodx.com.

    FREQUENTLY ASKED QUESTIONS

    • Is Immunoscore reimbursed?

    Immunoscore® may not be covered by insurance payers.
    However, Veracyte accepts most insurance plans, including Medicare. We will perform the services ordered and deemed medically necessary by the physician regardless of your network status.

    • Do you have a Financial Assistance Program?

    In the US, we have a Financial Assistance Program for eligible patients. Approval is based on your household size and your total household income. Please contact our billing department for further information at billing@haliodx.com or you can call us at 833-293-0101.

    • How do I apply for the Financial Assistance Program ?

    If you are based in the US, you can fill out the application form here and send it to our billing department at billing@haliodx.com

    • What is an Advanced Beneficiary Notice (ABN)? Why is it required for testing?

    An Advanced Beneficiary Notice (ABN) is a requirement mandated by Medicare. The purpose of the ABN is to help patients make an informed decision about whether they want to receive particular laboratory testing that have a likelihood of being denied for payment by Medicare. If the patient chooses to have Limited Coverage tests performed, the patient will have financial responsibility for the testing if Medicare denies payment. "

    • What is an Assignment of Benefits?

    A signed AOB gives Veracyte, the authorization to file a claim to your insurance and receive payments directly from your insurance for the testing services. If a patient is requesting Veracyte to bill their insurance provider, it is a requirement to sign and submit an AOB.

    • Is Veracyte considered “in network” with my insurance provider?

    Depending on your insurance provider, Veracyte may or may not be considered in Network with your insurance plan. However, Veracyte will perform the testing ordered by your Oncologist regardless of the network provider status.

    • I received an Explanation of Benefits (EOB) from my insurance company, am I responsible for the balance on the payer EOB?

    No, the Explanation of Benefits (EOB) from your insurance company is not a bill. You are not responsible for the balance stated on the EOB. If there is a balance due, you will receive a bill directly from Veracyte.

    • If my insurance claim is denied, will Veracyte submit an appeal to seek reimbursement for the test?

    Yes, Veracyte will exhaust all levels of appeals with your insurance company. Veracyte will work with your payer to pursue coverage for the testing performed."

    • How do I submit my bill to my secondary insurance?

    Veracyte will file all secondary insurance claims on your behalf. If you receive a bill and believe that a secondary claim has not been filed, contact our billing department toll free at 833-293-0101 and provide the secondary insurance payer.

    • What happens if my insurance pays me directly for the testing?

    If you receive a reimbursement check directly from your insurance provider, please endorse the check by signing the back of the check; write “Payable to Veracyte Inc (replace by HalioDx Inc.).” and send this with the signed Explanation of Benefits (EOB) document to Veracyte Inc (replace by HalioDx Inc.) . at 737 North 5th St, Suite 600, Richmond, VA 23219. Veracyte will contact and bill patients who receive direct reimbursement paymefrom their insurance company.

    • What happens if I cannot afford to pay for testing?

    Veracyte offers payment plan options with no additional interest. Patients can call the Billing Department toll free at 833-293-0101 or send an email to billing@haliodx.com to make the necessary financial arrangements.

    • May I pay my Veracyte bill over the phone?

    Yes, we accept Visa, Discover and Mastercard payments. Patients can call the Billing Department toll free at 833-293-0101 to submit payment.

    • Who can I contact if I have additional billing questions?

    You can contact our billing department by calling toll free 833-293-0101 or sending an email to billing@haliodx.com for further inquiries. A billing representative will respond to your call within 24-48 hours. Billing customer service representatives are available Mon-Fri from 8:00am to 6:00pm EST.

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