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This test requisition must be reviewed and signed by a healthcare provider before submitting a sample or going to a LifeLabs location. Download the requisition form and test ordering guide as a PDF.

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Signatera

What is SignateraTM used for?

SignateraTM is a personalized test used to detect molecular traces of cancer in the body. It helps doctors and oncologists make more informed decisions by determining whether:​

  • A person is responding to cancer treatment​
  • Additional treatment may be needed​
  • There are signs that the cancer has returned or progressed​

SignateraTM supports more timely and tailored care by identifying signs of cancer earlier than traditional imaging.

Who is the test used for?​

Individuals who have been diagnosed with solid tumours (e.g., Colorectal, breast, ovarian, lung, bladder, melanoma) or those diagnosed with cancer (solid tumours) being treated with immunotherapy, and are seeking answers to the following questions:​

  • Is there cancer left in the body?​​
  • Is additional treatment beneficial?​
  • Is the treatment working?​

SignateraTM is not currently recommended for leukemias, non-solid-mass lymphomas, and cancer behind the blood-brain barrier such as CNS tumours.

Who is the test used for Signatera​

How Signateraâ„¢ helps patients through their treatment?

Living scan to scan can sometimes create anxiety for patients. The question of relapse looms in the back of the mind: Did the treatment work? Is the cancer coming back?

Through shared decision making, patients can work closely with their care team to incorporate Signatera into their treatment plan to provide additional information for confident decision making.

Test Details

  • Individuals who have been diagnosed with solid tumours (e.g., Colorectal, breast, ovarian, lung, bladder, melanoma) or those diagnosed with cancer (solid tumours) being treated with immunotherapy, and are seeking answers to the following questions:

    • Is there cancer left in the body?
    • Is additional treatment beneficial?
    • Is the treatment working?

    SignateraTM is not currently recommended for leukemias, non-solid-mass lymphomas, and cancer behind the blood-brain barrier such as CNS tumours.

  • Knowing early if there are traces of cancer present in the body can help the doctor or oncologist decide whether:

    • An individual is responding to treatment
    • Further cancer treatment needs to be considered
    • There are signs that cancer has returned or progressed

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  • SignateraTM is a custom-designed test that is based on each patient’s unique set of tumor mutations. Knowing earlier if your cancer is likely to recur or has progressed after treatment can help you have a more informed discussion with your doctor on how to continue to treat or to detect changes in your disease.

    One-time analysis

    A one-time analysis of both blood and tissue determines your unique set of tumor mutations.

    Signateraâ„¢ test custom-built

    A SignateraTM test is custom-built and personalized for you.

    ctDNA levels monitored

    SignateraTM detects the increase or decrease of ctDNA each time it is ordered as part of your routine follow-up blood tests.

  • A positive SignateraTM result predicts relapse with an overall positive predictive value of more than 98%1-4.

    References

    1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stage I to III Colorectal Cancer. JAMA Oncology. 2019;5(8):1124-1131.
    2. Coombes C, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clinical Cancer Research. 2019;25(14):4255-4263.
    3. Abbosh C, Birkbak N, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017,545:446–451.
    4. Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients with Urothelial Bladder Carcinoma. 2019; 37(18):1547-1557.
    • Initial Test: 4-6 weeks*
    • Subsequent Test: 1-2 weeks*

    * In rare instances, turnaround times may be extended and/or require resubmissions of blood or tissue samples. The ordering healthcare provider will be notified in these instances. Turnaround times do not account for the time it takes the pathology lab to send the tumour sample; however, LifeLabs makes every attempt to expedite this process.

  • SignateraTM is recommended for periodic use over the course of your treatment as directed by your doctor to detect the presence of disease.