IMMUNOSCORE® for Rectal Cancer

Immunoscore® for Rectal Cancer can help identify patients with LARC who are at a low risk of relapse and may be good candidates for organ preservation. Immunoscore® is available through an Innovation Access Program while the company conducts clinical validation studies.

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For healthcare professionals

Predicting the Risk of Relapse with IMMUNOSCORE®: Evaluating Rectal cancer prognosis

3 illus_Patient_IC_Risk-Of-Relapse rectal V (1)

By providing an accurate measurement of T lymphocyte infiltration into the tumor, Immunoscore® gives healthcare providers insight into the risk of relapse.

A low or intermediate Immunoscore® means there are few T-cells present to fight the cancer, indicating a high risk of relapse. Conversely, a high Immunoscore® means there is high infiltration of T lymphocytes, indicating a lower risk of relapse.

3 illus_Patient_IC_Risk-Of-Relapse rectal V (1)

Benefits in the Clinic

Helping physicians identify candidates for Nonoperative Management (Watch and Wait) with Immunoscore® for Rectal Cancer

Management of patients with LARC is changing[1,2]. Patients who show a clinically complete response (cCR) to neoadjuvant treatment (NT) may be able to avoid total mesorectal excision (TME), a procedure which can lead to low patient quality of life[3].

But identifying the right patients for Nonoperative Management (Watch and Wait) has been difficult in the absence of a reliable biomarker predicting the risk of cancer recurrence.

A new study[4] has shown that Immunoscore® combined with imaging was able to identify very good responders to NT that could benefit from organ preservation strategy. In the "Watch and Wait" cohort, 100% success was observed in patients with Immunoscore High.

IMMUNOSCORE® predicts the clinical outcome of LARC patients[4]

Patients with Immunoscore High have a good clinical outcome (5 yr disease-free survival: 89% vs 63% vs 55%).

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LARC patients treated with CRT and radical surgery (n=238).

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LARC patients with complete clinical response to chemoradiotherapy
(n=73).

Immunoscore® selects LARC patients eligible for “Watch and Wait” approach[4]

Patients with complete clinical response and Immunoscore High do not relapse and may be eligible for organ preservation.

5 yr disease-free survival of patients treated with CRT and radical surgery by Immunoscore[4] :

89%

with Immunoscore High

63%

with Immunoscore Intermediate

55%

with Immunoscore Low

Frequently Asked Questions

Immunoscore® is a tissue-based immune test that measures the host's immune response at the site of the tumor. It is performed on formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from resections of Locally Advanced Rectal Cancer (LARC). The test uses whole slide imaging and artificial intelligence algorithms for assessment of the type, density, and location of T cells in FFPE tumor sections to determine an individual Immunoscore® for each patient.

In combination with TNM classification and other relevant clinical and biological data, IMMUNOSCORE® guides physicians on whether to propose a Nonoperative Management (Watch and Wait) approach to patients with a complete clinical response after neo-adjuvant treatment.

Once a sample is received by our laboratory, it should take no more than 10 working days to provide you with the result.

"The Innovation Access Program will give us the opportunity to include Immunoscore® in the evaluation of patient’s eligibility to Watch and Wait approach. It should give us more confidence in patient’s care and personalize our treatment plans."

Dr. John Low Seng Hooi., Clinical Oncologist at Pantai Hospital Kuala Lumpur,

Malaysia

Interested in ordering A test?

Select your Country

Immunoscore® for the management of locally advanced rectal cancer (LARC) is available in select locations through an Innovation Access Program (IAP). Find out if you can participate in the IAP by filling in the contact form below.

Contact us for details as the test is not available in the US

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Veracyte SAS

Luminy Biotech Entreprises
163 Avenue de Luminy
13288 Marseille Cedex 9
FRANCE

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    our programs

    Immunoscore® for Rectal Cancer is available Out of US through our Access Program. Please contact us to know more by filling in the contact form above.

    Step 1: Obtain specimen collection kits

    If you qualify for participation in the IAP, you will be given information on how to order a specimen collection kit. Please be sure to include the address for the laboratory where the patient’s specimen is stored so we can send the kit to the correct location.

    step_1_img@2x

    Step 2: Complete all documents provided within the collection kit

    Please be sure to supply all of the requested information on the forms that are included in the specimen collection kit.

    Please be sure to supply all of the requested information on the forms that are included in the specimen collection kit.

    You can also download the necessary information using the link below:

    TEST REQUEST FORM

    step2

    Step 3: Prepare and send the patient sample

    Veracyte can work directly with the pathology team and treating physician to facilitate specimen collection.

    The tissue specimen should be from tumor biopsy at diagnosis of patients with LARC and not from a site of metastasis. You can send either an FFPE tumor block or 4 µm unstained slides from an FFPE block (6 slides required per test).

    To prepare the patient specimen, follow the instructions in the Samples Preparation Instructions included in the kit.

    Once the sample is prepared and placed in the specimen collection kit along with the required documentation, return the kit to Veracyte.

    HalioDx can work directly with the pathology team and treating physician to facilitate specimen collection.

    The tissue specimen should be from tumor biopsy at diagnosis of patients with LARC and not from a site of metastasis. You can send either an FFPE tumor block or 4 µm unstained slides from an FFPE block (6 slides required per test).

    To prepare the patient specimen, follow the instructions in the following downloadable document:

    Once the sample is prepared and placed in the specimen collection kit along with the required documentation, return the kit to HalioDx.

    shipment-@2x

    Step 4: Access your IMMUNOSCORE Results

    The turnaround time for Immunoscore® testing is a maximum of 10 working days. Turnaround time is considered from the day the specimen is received at our laboratory to the time the test is reported to the ordering physician.

    You will receive the Immunoscore® results by email.

    You can also directly log in to the Oncology Portal to get the results.

    step4

    Step 1: Obtain specimen collection kits

    If you qualify for participation in the IAP, you will be given information on how to order a specimen collection kit. Please be sure to include the address for the laboratory where the patient’s specimen is stored so we can send the kit to the correct location.

    step_1_img@2x

    Step 2: Complete all documents provided within the collection kit

    Please be sure to supply all of the requested information on the forms that are included in the specimen collection kit.

    You can also download the necessary information using the link below:

    step2

    Step 3: Prepare and send the patient sample

    Veracyte can work directly with the pathology team and treating physician to facilitate specimen collection.

    The tissue specimen should be from tumor biopsy at diagnosis of patients with LARC and not from a site of metastasis. You can send either an FFPE tumor block or 4 µm unstained slides from an FFPE block (6 slides required per test).

    To prepare the patient specimen, follow the instructions in the following downloadable document:

    Samples Preparation Instructions
    Once the sample is prepared and placed in the specimen collection kit along with the required documentation, return the kit to Veracyte.

    HalioDx can work directly with the pathology team and treating physician to facilitate specimen collection.

    The tissue specimen should be from tumor biopsy at diagnosis of patients with LARC and not from a site of metastasis. You can send either an FFPE tumor block or 4 µm unstained slides from an FFPE block (6 slides required per test).

    To prepare the patient specimen, follow the instructions in the Samples Preparation Instructions included in the kit.

    Once the sample is prepared and placed in the specimen collection kit along with the required documentation, return the kit to HalioDx.

    shipment-@2x

    Step 4: Access your IMMUNOSCORE Results

    The turnaround time for Immunoscore® testing is a maximum of 10 working days. Turnaround time is considered from the day the specimen is received at our laboratory to the time the test is reported to the ordering physician.

    You will receive the Immunoscore® results by email.

    You can also directly log in to the Oncology Portal to get the results.

    step4

    Top Resources for healthcare professionals

    Contact Our Team to Inquire About IMMUNOSCORE

    Distributor and commercial team area

    References

    1. Hill GL and Rafique M. Extrafascial excision of the rectum for rectal cancer. Br J Surg. 1998 Jun;85(6):809-12.
    2. Bjerkeset T and Edna TH. Rectal cancer: the influence of type of operation on local recurrence and survival. Eur J Surg. 1996 Aug;162(8):643-8.
    3. Pieniowski EHA, et al. Prevalence of low anterior resection syndrome and impact on quality of life after rectal cancer surgery: population-based study. BJS Open. 2020 Oct;4(5):935-942.
    4. El Sissy C, et al. A Diagnostic Biopsy-Adapted Immunoscore Predicts Response to Neoadjuvant Treatment and Selects Patients with Rectal Cancer Eligible for a Watch-and-Wait Strategy. Clin Cancer Res. 2020 Oct 1;26(19):5198-5207.
    5. Anitei M-G, et al. Prognostic and predictive values of the immunoscore in patients with rectal cancer. Clin Cancer Res. 2014 Apr 1;20(7):1891-9.