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CancerIntercept® Detect

CancerIntercept® Detect is a blood-based non-invasive test that can be used by physicians for the detection of circulating tumor DNA (ctDNA). Presence of increased levels of ctDNA and of the distinct mutations in the covered driver genes has been seen in many cancer types when disease is developing or is present. This test works by analyzing cell-free DNA (cfDNA). It detects the presence of specific genomic markers called circulating tumor DNA (ctDNA) in 9 cancer driver genes. CancerIntercept® Detect delivers results in just 2 to 3 weeks.

Learn More About CancerIntercept® Detect

CancerIntercept® Detect is a blood-based non-invasive test that can be used as a tool by physicians for the detection of circulating tumor ctDNA. Presence of increased levels of ctDNA and distinct mutations has been seen in many cancer types.

Liquid Biopsy Definition

Liquid biopsy is a molecular diagnostics technique that uses bodily fluids, such as blood, to analyze tumor DNA that is present in patients found to have cancer.

Both normal and tumor cells release small DNA fragments into the bloodstream (cell-free DNA or cfDNA). Analysis of circulating tumor DNA may give valuable information about the underlying genomic make-up of a patient’s tumor.

Appropriate Candidates for Testing

CancerIntercept® Detect is available for patients that are at high risk to develop cancer in their lifetime.

There are a number of conditions that may put on individual at an increased risk for the development of cancer, including, but not limited to:

  • Known predisposition to a hereditary cancer syndrome (i.e. the individual carries a BRCA1 pathogenic variant)
  • A family history of cancer (i.e. a mother and grandmother diagnosed with colon cancer)
  • Lifestyle choices (i.e. a lifetime history of heavy smoking)
  • Environmental exposures (i.e. extensive exposure to radiation)

Our complete clinical history questionnaire, which details the potential risk factors for cancer, can be found here.

In order for an individual to be eligible to order CancerIntercept® Detect, he or she must be at an increased risk, to be acknowledged by their physician. Eligibility will be reviewed by Pathway Genomics clinical staff. CancerIntercept® is not for asymptomatic individuals that have no known risk factors.

How Does Testing Work?

Many types of cancers can be difficult to diagnose at an early stage and give poor outcome if not identified at an early stage. Using cutting-edge technology, CancerIntercept® Detect offers physicians a new tool to look for ctDNA in high-risk patients to potentially aid in early diagnosis.

CancerIntercept® Detect is a non-invasive testing method that utilizes blood plasma to test for circulating tumor DNA. Both tumor and non-tumor cells release small DNA fragments into the bloodstream. Presence of increased levels of ctDNA and of the distinct mutations in the covered driver genes has been seen in many cancer types when disease is developing or is present. This test works by analyzing cell-free DNA (cfDNA). It detects the presence of specific genomic markers called circulating tumor DNA (ctDNA) in 9 cancer driver genes.

Testing is by physician order. After all paperwork is submitted to Pathway, and patient eligibility is confirmed by our clinical staff, a sample collection kit will be sent to the patient’s primary care physician or to the phlebotomist for the blood draw. All samples are processed in our CLIA/CAP approved laboratory in San Diego.

This test is not diagnostic. A positive result with CancerIntercept® Detect requires additional confirmatory testing to rule in, or rule out, the presence of a cancer diagnosis.

A negative result means that none of the 96 genomic markers included in this test were identified in the blood sample provided. This result does not rule out the presence of a current or future cancer, nor does it change the patient’s future cancer risk.

Results are released to the patient’s physician and the patient on request. A positive result is released first to the patient’s primary care physician and then to the patient, so that results can be discussed.

Negative test results are released to the patient’s physician and the patient. Pathway’s oncologist is available to consult with the patient’s physician about the test results.

What Exactly Is Being Tested?

An individual’s blood plasma is analyzed for the presence of 96 specific genomic markers that are potentially found in several specific tumor types. Please click below for a full list of the included markers.

What Can This Test Tell You- Icon
What Can The Test Actually Tell You and Your Physician?

CancerIntercept® Detect can be used by physicians to test for a set of genomic markers (ctDNA) that have previously been associated with a number of different cancer types.The presence of one or more of these genomic markers in a patient’s plasma sample may indicate that the patient has a tumor that is shedding ctDNA into the blood stream. However, the test is not diagnostic, and thus, follow-up screening and clinical testing would be required to confirm the presence or absence of a specific cancer in the patient.

Subscription Pricing

CI-Detect Prices

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Detection Rate

Detectable Levels

Liquid biopsy tests, such as CancerIntercept® Detect, can detect circulating tumor DNA, the presence of which is associated with a number of cancer types.

Detectable Levels

According to a study conducted by Bettegowda, et al. 2014, ctDNA is potentially detectable at all stages of disease (I-IV), albeit at varying detection rates.

Detectable Levels Chart


Proportions

Liquid biopsy tests, such as CancerIntercept® Detect, can detect ctDNA. The tested mutations have been shown to be present in a number of cancer types, in both the tumor tissue, and in plasma as ctDNA.

Proportions

Research by Bettegowda, et al. 2014, has demonstrated very high detection rates (for ctDNA) for multiple cancer types in patients with advanced disease. The graph below demonstrates the detection rate in several of the cancer types targeted with CancerIntercept™ Detect.

Proportion Cancer Cases


Perrone Study

A recent study by Perrone et al. (2014) showed promising results for the application of ctDNA mutation analysis as a screening tool for individuals at high risk of developing colorectal cancer.

Perrone Study


Potential Test Results

Positive Results

One or more of the 96 genomic markers analyzed by this test were identified in the blood sample provided. A positive result may indicate that the patient has an undetected tumor that is shedding DNA into the bloodstream. However, CancerIntercept™ Detect is not diagnostic. Thus, follow-up clinical examination and other testing would be required to confirm or rule-out the presence of cancer.



Negative Results

None of the 96 genomic markers included in this test were identified in the blood sample provided. This result does not rule out the presence of a current or future cancer, nor does it change the patient’s future cancer risk. Furthermore, this result only applies to the mutations analyzed by this test; this test does not provide any information for other mutations in these or other genes related to different cancer types. Follow-up screening recommendations should not be altered based on these results.




Learn More About Ordering Process

If preferred, Pathway Genomics can designate an ordering physician for a patient through its online physician network. However, please note that the patient will be required to identify and provide contact information of the patient’s primary care physician in order to utilize this option. This test requires a physician order and physician contact to discuss results. Positive results are released to the patient through the patient’s physician. A member of Pathway’s Oncology Support Team is available to discuss results with the patient’s physician.

Negative test results are released to the patient’s physician and the patient; positive results are released first to the patient’s primary care physician and then to the patient.

CancerIntercept® tests are available by physician order only.

CancerIntercept® Detect Test Description

CancerIntercept® Detect is a blood-based non-invasive test that can be used by physicians for the detection of circulating tumor ctDNA. Presence of increased levels of ctDNA and of the distinct mutations in the covered driver genes has been seen in many cancer types when disease is developing or is present. This test works by analyzing cell-free DNA (cfDNA). It detects the presence of specific genomic markers called circulating tumor DNA (ctDNA).

Limitations and Warnings

Pathway Genomics’ CancerIntercept™ test is a plasma-based 96 mutation panel for the detection of circulating tumor DNA (ctDNA). Cancer is heterogeneous disease that can occur as a result of somatic mutations in various driver genes. Pathway’s CancerIntercept™ (Monitor or Detect) identifies somatic cancer derived mutations present as ctDNA at 96 hotspots in 9 cancer driver genes. This test is not meant to diagnose cancer. It is giving information about the presence of increased levels of ctDNA and of the distinct mutations in the covered driver genes that have been seen in many cancer types when disease is developing or is present. Test information is to be used as an adjunct to other medical examinations and interventions. Since this is a 96 mutation hotspot panel, it will not detect all mutations associated with known cancers. No test can replace a physician’s examination, imaging studies, and tissue biopsies as the gold-standard for cancer diagnosis. It is possible that mutations in these or other genes not tested in Pathway’s CancerIntercept™ (Monitor or Detect) test may be involved in the patient’s disease. Therefore, a negative test result, where no mutations are detected, does not eliminate involvement of other genes and/or mutations. Furthermore, a positive test result needs to be interpreted in the context of individual’s clinical history including stage of disease, imaging results, therapeutic details, and other laboratory data. Pathway Genomics Corporation strives to provide the most accurate test results. Results could be misinterpreted if clinical information provided is inaccurate or incomplete. Improper blood sampling and handling could result in error. Genetic counseling or medical consultation is recommended for the individual tested. The performance characteristics for the Pathway Genomics testing services described herein were established and validated by Pathway Genomics according to the requirements of CLIA (Clinical Laboratory Improvement Amendments of 1988). These testing services have not been cleared or approved by the U.S. Food and Drug Administration (FDA).

References

References

  1. Rothschild, S.I., Targeted Therapies in Non-Small Cell Lung Cancer-Beyond EGFR and ALK. Cancers (Basel), 2015. 7(2): p. 930-49.
  2. Tabernero, J, et al. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol, 2015. [Epub ahead of print]. Ascierto, P.A., et al., Phase II trial (BREAK-2) of the BRAF inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma. J Clin Oncol, 2013. 31(26): p. 3205-11.
  3. Romero, A., et al., Identification of E545k mutation in plasma from a PIK3CA wild-type metastatic breast cancer patient by array-based digital polymerase chain reaction: Circulating-free DNA a powerful tool for biomarker testing in advance disease. Transl Res, 2015. Heidary, M., et al., The dynamic range of circulating tumor DNA in metastatic breast cancer. Breast Cancer Res, 2014. 16(4): p. 421.
  4. Zill, O.A., et al., Cell-Free DNA Next-Generation Sequencing in Pancreatobiliary Carcinomas. Cancer Discov, 2015.
  5. Janku, F., et al., Actionable mutations in plasma cell-free DNA in patients with advanced cancers referred for experimental targeted therapies. Oncotarget, 2015. 6(14): p. 12809-21.
  6. Forshew, T., et al., Noninvasive identification and monitoring of cancer mutations by targeted deep sequencing of plasma DNA. Sci Transl Med, 2012. 4(136): p. 136ra68.
  7. Dawson, S.J., et al., Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med, 2013. 368(13): p. 1199-209.
  8. Ignatiadis, M. and S.J. Dawson, Circulating tumor cells and circulating tumor DNA for precision medicine: dream or reality? Ann Oncol, 2014. 25(12): p. 2304-13.
  9. Murtaza, M., et al., Non-invasive analysis of acquired resistance to cancer therapy by sequencing of plasma DNA. Nature, 2013. 497(7447): p. 108-12.
  10. Kidess E., et al., Mutation profiling of tumor DNA from plasma and tumor tissue of colorectal cancer patients with a novel, high-sensitivity multiplexed mutation detection platform. Oncotarget, 2014. 6(4): p. 2549-2561.
  11. Olsson, E. et al. Serial monitoring of circulating tumor DNA in patients with primary breast cancer for detection of occult metastatic disease. EMBO Molecular Medicine 2015. [Epub ahead of print].
  12. Bettegowda, C., et al., Detection of Circulating Tumor DNA in Early- and Late-Stage Human Malignancies. Science Transl Med, 2015. 6(224):pp.224ra24.
  13. Perrone, F., et al., Circulating free DNA ina screening program for early colorectal cancer detection. Tumori, 2014. 100:pp.115-121.