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Canadian Early Access Program for FOLLOW IT®Cancer ctDNA Liquid Biopsy testing


 


Canadian Early Access Program for FOLLOW IT Cancer ctDNA Liquid Biopsy Testing

Contextual Genomics provides access to  FOLLOW IT, a blood-based circulating tumour DNA (ctDNA) next-generation sequencing (NGS) hotspot panel to oncologists and patients in British Columbia and Ontario.

The Program aims to enable access to high quality and affordable liquid biopsy cancer genomic testing to cancer patients. 

FOLLOW IT results may help oncologists direct therapy selection and clinical trial options for their patients.



What is the Canadian Early Access Program for FOLLOW IT cancer testing?

The Canadian Early Access Program (CEAP) provides oncologists and patients with access to a blood-based, clinically actionable, multiplex hotspot mutation panel using next-generation sequencing (NGS) known as FOLLOW IT. This is a patient pay program that is currently only open to patients in BC and Ontario.

What information does the FOLLOW IT test provide?

FOLLOW IT is blood-based “liquid biopsy” NGS multiplex panel that tests for 146 hotspots and 23 exons in 30 cancer genes that are known to be important in prognosis and treatment of multiple solid adult tumours. For example, hotspots in the genes: BRAF, EGFR, KRAS, MET, PIK3CA, etc. For the FOLLOW IT gene list Click here. The FOLLOW IT test provides a detailed clinical report which includes interpretations of results, available clinical trials and current treatment options based on the molecular profile of the tumour.

Who is the eligible patient population that may benefit from testing?

Currently we are accepting patients diagnosed with metastatic breast cancer, lung cancer, and gastrointestinal cancers. Patients with suspected or known relapsed disease where tumour biopsy may not be feasible may benefit from FOLLOW IT testing to detect resistance mutations and/or other targetable mutations.

In the case of patients diagnosed with other metastatic tumour types not included in this program, please contact us to discuss potential testing options for your patient.

Where is the Testing Performed?

Patients will take their Test Requisition Form (TRF) provided by the referring oncologist to a LifeLabs location where blood is taken and shipped directly to Contextual Genomics. All Testing is performed in Contextual Genomics’ state-of-the art clinically accredited laboratory in Vancouver, British Columbia, Canada.

What is the Expected Turnaround Time?

Contextual Genomics will provide results to the ordering oncologist within 10 business days from the receipt of the blood sample.

What is the benefit of using FOLLOW IT testing in my practice?

  • FOLLOW IT blood-based ctDNA testing allows for less invasive sampling, compared to tissue biopsy, while providing the oncologist with genomic data.
  • The genomic information provided may identify and help to select the most relevant targeted therapies available to the patient. The FOLLOW IT test is focused on actionable results, including biomarkers associated with response to FDA and Health Canada approved therapies, as well as current Canadian clinical trials. For FOLLOW IT genes and corresponding therapies Click here. The FOLLOW IT report can help guide treatment options available to the patient that may not be accessible without this advanced molecular testing.
  • Our rapid turnaround time enables the implementation of an effective treatment plan within a meaningful timeframe.
  • Our test is affordable for patients compared to other US based companies, and testing is performed within Canada.

How do I refer patients for FOLLOW IT testing?

To refer patients for FOLLOW IT testing, please follow the instructions below:

  • Complete a Test Requisition Form (TRF).
  • To provide notice of incoming sample, please fax requisition & a copy of the pathology report to Contextual Genomics at 1-(778)-379-3567
  • Provide requisition to patient, and have them visit their local LifeLabs patient service centre for blood collection and payment

If you have any questions regarding the Canadian Early Access Program, please email us at test@contextualgenomics.com or call 1-(778)-379-2931.

Where is the Canadian Early Access Program available?

The Canadian Early Access Program is currently able to accept only patients in BC and Ontario.


What is genomic testing?

Cancer is a disease in which the cells grow and divide out of control. Within each cell are many genes (the genome, made up of DNA) which  controls growth and division. Mutations (alterations or changes) in genes can affect how the cells grow and develop. Mutations in some of these genes can lead to cancer. There are many treatment options available for cancer patients, however, individual cancers that contain specific mutations may respond differently to the same therapy. The goal of genomic testing is to provide more information about specific gene mutations that may be present in your tumour so that your oncologist can recommend the most appropriate treatments.

Your oncologist can discuss and determine if genomic testing is right for you.

What is the circulating tumour DNA (ctDNA) liquid biopsy FOLLOW IT test?

Circulating tumour DNA (ctDNA) are small pieces of DNA that come from tumour cells which can be found in your blood. As the tumour grows, its cells die and are replaced by new cancer cells. The dying tumour cells are broken down and their contents, including DNA, are discharged into the circulating bloodstream.

The FOLLOW IT test is a less invasive, blood-based ctDNA assay that tests for 146 of the most common mutations found in many adult solid tumours. The FOLLOW IT test requires a simple blood draw, similar to routine blood tests and will be taken at a BC or Ontario LifeLabs location convenient for you. Your blood sample is then sent directly to the Contextual Genomics laboratory in Vancouver, BC for testing.

Once your blood sample arrives in our laboratory we will isolate the plasma portion of blood, which contains the ctDNA fragments. Then using FOLLOW IT we can determine the ctDNA mutations without the need for an invasive tumour biopsy. This is important because in patients with metastatic cancer, performing a tumour biopsy may be too difficult and invasive. Based on the presence of a specific ctDNA mutation detected in your blood sample, your oncologist may be able to select the most appropriate targeted cancer treatment.

Who is eligible for FOLLOW IT testing?

Patients with metastatic breast cancer, lung cancer or colorectal cancers may benefit from testing with FOLLOW IT. At this time, we do not test hematological blood-based cancers such as lymphomas or leukemias.

Please talk to your oncologist to determine if FOLLOW IT testing is appropriate for you.

HOW DOES THIS TYPE OF TESTING HELP TREATMENT DECISIONS?

The FOLLOW IT test results may provide you and your oncologist with a better understanding of the gene mutations found in your tumour, thus allowing for the selection of targeted treatment options. This treatment may include a specific drug, standard treatment or an experimental drug where participation in a clinical trial may be suggested. Your oncologist will determine the most appropriate course of action regarding your therapy once the FOLLOW IT results are available.

HOW CAN I GET TESTED?

Please consult your oncologist to determine whether you would benefit from FOLLOW IT cancer testing. If deemed clinically beneficial, your oncologist can arrange for testing. Contextual Genomics does not play a role in selecting patients for the testing and does not offer testing to patients directly. 

If you are eligible for FOLLOW IT testing, your oncologist will need to fill out the appropriate Test Requisition Form (TRF), which will then be taken to your nearest LifeLabs where payment for the test can be made. Once your blood is drawn, your samples will immediately be sent to the Contextual Genomics laboratory in Vancouver, BC.

HOW DO I LET MY ONCOLOGIST KNOW ABOUT THIS TEST?

Your oncologist can contact Contextual Genomics at test@contextualgenomics.com or go to our website at www.contextualgenomics.com/access  for more information.

WHAT IF MY ONCOLOGIST  DOES NOT KNOW ABOUT THE TEST, CAN I STILL HAVE ACCESS TO IT?

Please discuss the test with your oncologist as they are the best person to determine the benefits of this testing for you. Your oncologist can contact us to receive more information about the FOLLOW IT test if it is deemed clinically beneficial for you. Contextual Genomics does not play a role in selecting patients for the testing.

CAN MY General Practitioner REFER ME FOR YOUR TEST?

No. You have to be referred by your oncologist for this test.

WILL THIS TEST DETERMINE MY OR MY FAMILY’S SUSCEPTIBILITY TO CANCER?

No, the FOLLOW IT test is for patients who already have cancer. It is designed to give more information about your tumour  so that the most appropriate therapy can be chosen for you. Some types of cancers, called hereditary cancer can result from genetic changes being passed down from your parents that may  increase the chances of developing certain types of cancer in your lifetime. Contextual Genomics does not specifically test for these types of mutations. 

HOW MUCH DOES THE TEST COST?

For the Canadian Early Access Program, the FOLLOW IT test is currently offered for $500 CAD which is paid by the patient.

WHERE IS MY SAMPLE SENT AFTER MY BLOOD DRAW?

Your blood tubes will be immediately sent for testing in the Contextual Genomics’ state-of-the art clinically accredited laboratory in Vancouver, British Columbia, Canada.

HOW LONG DOES IT TAKE TO RECEIVE RESULTS?

A detailed clinical report will be sent to your oncologist within 10 business days of your sample being received by the Contextual Genomics laboratory.

DO YOU ENSURE MY PRIVACY AND CONFIDENTIALITY?

Contextual Genomics is governed by the Personal Health Information Protection Act, 2004 (PHIPA) in the province of Ontario, the Personal Information Protection Act (PIPA) in the province of British Columbia and The Personal Information Protection and Electronic
Documents Act (PIPEDA). We are also compliant with Health Insurance Portability and Accountability Act – USA (HIPPA).
Contextual Genomics takes appropriate measures to protect personal health information in its possession from loss, misuse and unauthorized access, disclosure, alteration and destruction. We have implemented state-of-the-art physical, administrative and technical safeguards to protect the confidentiality, integrity and availability of personal data residing on, processed by or transmitted by our servers.

CAN A CHILD BE TESTED?

No, the FOLLOW IT test is not designed to test mutations that are found in pediatric (childhood) cancers.