OncoDefender

Early Stage Colorectal Cancer – the Real Risks and New Opportunities for Improved Patient Outcomes:

Historically, early stage colorectal cancer (i.e. Stage I/II) was believed to be relatively easily treated with surgical removal of the tumor and that few patients would experience a recurrence of their colorectal cancer.  Furthermore, it was believed that adjuvant chemotherapy for Stage I/II colorectal patients was not required because it had little impact on recurrence or survival rates.  This legacy perspective was largely driven by the assumption that all Stage I/II tumors were essentially the same and were all “low-risk tumors”.

Clinically Important New Insights:

Recently completed studies have provided clinically important insights which reveal that all early stage colorectal tumors are not the same:

1. Recurrence and mortality rates associated with Stage I/II Colorectal Cancer are much higher than previously realized¹:
    
   • Stage I Colorectal Cancer:  ~1 in 7 patients with Stage I colorectal cancer, (that have undergone surgical resection of their tumor), will have a recurrence of their cancer
   • Mortality Rates for Recurrent Stage I Patients:  Over half of those patients (>50%) that recur will die from their disease
   • Stage II Color Cancer:  ~1 in 3 patients of Stage II colon cancer patients, (that have undergone surgical resection of their tumor), will have a recurrence of their cancer
   • Mortality Rates for Recurrent Stage II Patients:  Most of those patients that recur (>80%) will die from their disease
2. All early stage colorectal cancer tumors are not the same, some types of Stage I/II colorectal cancer tumors have a much higher risk of recurrence and mortality:
    
   • “Of the 176 patients…only 4 (low risk patients) developed tumor recurrence (2.3%), compared with 33.3% for intermediate (risk), and 68% for high-risk patients.²”
     • Patients with intermediate-risk tumors are ~14X more likely to have a recurrence than patients with low risk tumors.
     • Patients with high-risk tumors are ~29X more likely to have a recurrence than patients with low risk tumors.
3. There is a growing body of evidence that Stage I/II patients with high-risk tumors have recurrence and mortality rates that are more typically associated with Stage III tumors³:
    
   • “While the overall survival in Stage II patients is approximately 70%–80% 5 years after surgery, in high-risk stage II disease, the clinical outcome is similar to that of patients with stage III disease.”
   • “Currently, these high-risk patients are identified by tumors that not only penetrate the bowel wall but also show evidence of adhesion to or invasion of surrounding structures, free perforation, obstruction, or aneuploidy.”
   • “More importantly, recent data, using molecular markers or the presence of micro-satellite stable tumors, have helped to identify a subgroup of patients with both stage II and stage III CRC who may have much worse prognoses and in whom the administration of chemotherapy may be beneficial”
4. Importantly, recent studies have demonstrated that patients identified with high-risk tumors benefit significantly from adjuvant therapy; (earlier studies suggested that adjuvant therapy had little impact on recurrence rates precisely because they were unable to distinguish early stage low-risk tumors from early stage high-risk tumors):
    
   • “High-risk patients (n=102), but not other patients with stage II colon cancer, benefited from adjuvant therapy (3-year disease-free survival: 96.4% vs. 84.7%, p = 0.045; 5-year overall survival: 100% vs. 86.4%, p = 0.015)⁴.”
5. Patients identified with high-risk early stage colorectal cancer tumors benefit significantly from both surgical removal of their tumor followed by adjuvant therapy.

Important Implications for Early Stage Colorectal Cancer Patients:

1. Colorectal cancer patients with high-risk tumors are likely to benefit from adjuvant therapy, with the potential for lower rates of recurrence of their cancer and improved survival rates.
2. This requires distinguishing between patients that have an early stage low-risk tumor and those that have early stage high-risk tumor.
3. In order to accomplish these improved outcomes requires a testing method that will help physicians identify patients with low-risk versus high-risk tumors.

The Breakthrough - OncoDefender-CRC Distinguishes Between High-Risk and Low Risk Tumors, Predicting Risk of Recurrence: 

OncoDefender-CRC is the world’s first molecular diagnostic test capable of accurately distinguishing between high-risk and low-risk tumors, predicting the risk of recurrence of cancer in patients previously treated with surgical resection of a Stage I/II colon cancer tumor or Stage I rectal cancer tumor.  According to an independent statistical review, test results correlate well with accurately predicting colorectal cancer recurrence. In studies, no other currently available molecular diagnostic test approaches the performance capabilities of OncoDefender-CRC in this regard.

• The OncoDefender–CRC test is performed at the company’s Ann Arbor, Michigan headquartered laboratory.  The tumor analysis requires formalin-fixed, paraffin-embedded tumor tissue.
• Results Reported Rapidly:  Results of the OncoDefender-CRC assay are available within 7 to 10 days from the date the tumor sample is received by Everist Genomics.

Clinical Utility of OncoDefender-CRC: 

Patients identified by OncoDefender-CRC at high-risk of cancer recurrence are likely to benefit from adjuvant therapy or other more aggressive treatment options.

• Independent studies⁵ have demonstrated a significant improvement in overall survival rates for high-risk Stage I and Stage II colorectal cancer patients receiving adjuvant therapy within 60 days following surgical resection of their tumor.
• The OncoDefender-CRC test will help physicians make appropriate post-surgical decisions about the need for adjuvant therapy.

Eligible Patients: 

All patients that have undergone surgical resection of a Stage I/II colon cancer tumor or Stage I rectal cancer tumor are eligible for the Everist Genomics OncoDefender-CRC test and are likely to benefit from use of the test.

Regulatory Clearance: 

The developers of OncoDefender-CRC, Everist Genomics, Inc., has secured registration to perform the OncoDefender-CRC test from the United States Clinical Laboratory Improvement Amendments, (CLIA); CLIA ID number 23 D 201 7844.  CLIA is administered by the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid services (CMS) and the Centers for Disease Control (CDC).

• CLIA regulations are based on the complexity of the test method.  The more complicated the test, the more stringent the requirements.  By law, laboratories conducting High-Complexity testing are required to meet CLIA specified quality standards, proficiency measures and undergo proficiency testing.
• The OncoDefender–CRC test has been classified as a High-Complexity test according to CLIA guidelines and meets the most stringent requirements and quality standards established by CLIA required for High-Complexity testing. 

Clinically and Economically Important Advance: 

OncoDefender-CRC test represents an important advance in the assessment of risk of recurrence of colorectal cancer and overcomes the limitations of currently available tests:

• OncoDefender-CRC exceeds the performance characteristics which are typically achieved by applying standard of care guidelines alone.
• OncoDefender-CRC also overcomes the limitations of currently available molecular diagnostics.  These limitations include:
  • The competing test is confined to use in Stage II colon cancer patients alone.  Whereas, OncoDefender-CRC can be used for assessing risk of recurrence in Stage I/II colon cancer and Stage I rectal cancer patients.
  • The competing test is significantly less effective in identifying patients at high-risk of recurrence relative to OncoDefender.
  • The competing test fails to provide a test result in about 25% of all patients tested.  Competitors also refer to this as a ‘no-call result’.  This means 25 out of every 100 patients referred for the competing test will get no usable results, while each patient will have previously paid for testing.
  • By contrast the OncoDefender-CRC test produces zero no-call results and provides an accurate assessment of risk of recurrence for every patient tested.

Insurance Coverage and Financial Assistance: 

Regardless of your insurance coverage or financial status, the Everist Genomics Customer Care team will assist you in obtaining the testing you need.

• Everist Takes Care of the Paperwork:  Everist Genomics will bill the insurance company (or Medicare) directly on your behalf.
• Everist Genomics Financial Assistance Programs:  In the event that your patient’s insurance company denies coverage, or if you require financial assistance, Everist Genomics also has a generous financial assistance program that will cover 80% of the cost of OnocDefender-CRC test.
• Financial Benefits Confirmed Rapidly:  Within 3 to 4 working days of receiving the completed application for OncoDefender-CRC testing, Everist Genomics will provide you and your physician with written confirmation of their financial benefits as well as how to proceed with testing.

 

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1. National Cancer Institute 2011 and American Cancer Society 2011
2. Source: Does Stage II Colorectal Cancer Need to be Redefined?  Author: Axel Grothey; published in Clin Cancer Res Published OnlineFirst April 15, 2011.
3. Source: The Oncologist, Vol. 10, No. 5, 332-334, May 2005; doi:10.1634/theoncologist.10-5-332 © 2005. Stage II Colorectal Cancer: To Treat or not to Treat; Patrick G. Johnston Centre for Cancer Research and Cell Biology, Queen’s University Belfast, Belfast, Northern Ireland
4. Source: Is adjuvant chemotherapy beneficial to high risk stage II colon cancer? Analysis in a single institute. Chun-Chi Lin & Jen-Kou Lin & Shih-Ching Chang & Huann-Sheng Wang & Shung-Haur Yang & Jeng-Kai Jiang &Wei-Shone Chen & Tzu-Chen Lin; Accepted: 8 January 2009 / Published online: 24 February 2009; Int J Colorectal Dis (2009) 24:665–676
5. Gastrointestinal Cancers Symposium, Source reference:  Biagi JJ et al. "Time to adjuvant chemotherapy in colorectal cancer: Systematic review and meta-analysis" ASCO GI 2011; Abstract 364; Bayraktar UD, Chen E, Bayraktar S, Sands LR, Marchetti F, Montero AJ,Rocha-Lima CM. Does delay of adjuvant chemotherapy impact survival in patients with resected stage II and III colon adenocarcinoma? Cancer. 2010 Dec 17.; J Clin Oncol. 2010 Jan 20;28(3):460-5. Epub 2009 Dec 14.  Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon cancer: simulations based on the 20,800 patient ACCENT data set.  de Gramont A, Hubbard J, Shi Q, O'Connell MJ, Buyse M, Benedetti J, Bot B, O'Callaghan C, Yothers G, Goldberg RM, Blanke CD, Benson A, Deng Q, Alberts SR, Andre T, Wolmark N, Grothey A, Sargent D. Hopital Saint Antoine, Group Hospitalier Pitie-Salpetriere, Paris, France; et. Al.

Insurance Coverage and Financial Assistance Programs

Regardless of insurance coverage or financial status, the Everist Genomics Customer Care team will assist you in obtaining the testing you need. The Everist Genomics Customer Care team will support you with insurance claims, appeals, and financial assistance programs.  You may be eligible to have up to 80% of the cost of the OncoDefender test covered on your behalf by one of the Everist Genomics Financial Assistance programs.

Within 3 to 4 working days of receiving your completed application for testing, Everist Genomics will provide you and your doctor with written confirmation of your financial benefits as well as how to proceed.

Patients with Insurance or Medicare Coverage:

Everist Genomics will bill insurance companies on behalf of insured patients. Some insurance companies will pay the entire charge and some will pay a portion of the charge based on individual patient benefit levels. With a signed Patient Information and Assignment of Benefits form (AOB), Everist Genomics will work directly with your insurance company or Medicare on your behalf.  Everist Genomics will accept the insurance payment (together with your co-pay, deductible or co-insurance) as payment in full.

Patients Denied Reimbursement by their Insurance Company:

If your insurance company denies payment for your OncoDefender-CRC test, the Everist Genomics Customer Care team can assist you with eligibility for a discounted payment program tailored specifically for you.

Patients with no Insurance or Requiring Financial Assistance:

If you do not have health care insurance or require financial assistance, Everist Genomics offers a variety of financial assistance programs with options based on individual financial status and eligibility which may cover up to 80% of the cost of the OncoDefender-CRC test.

We do the work for you

As soon as we receive your completed Assignment of Benefits form we will assist you every step along the way, from assisting with securing benefits coverage (either from your insurer, Medicare or financial assistance provided by Everist Genomics) to conducting and reporting the results of your OncoDefender-CRC Test to your physician.

How to Get Started

We understand there are several factors affecting your decision to utilize the OncoDefender-CRC Test. Everist Genomics is dedicated to assisting you, your family and your physician throughout the entire process.

For Patients with Insurance or Medicare Coverage:

• Step 1
  Complete the Patient Information Sheet and Assignment of Insurance Benefits (AOB) form. This short form allows us to verify your insurance coverage and to assist with determining your eligibility for financial assistance for you with no further obligation.
• Step 2
  Submit this information to Everist Genomics Customer Support by faxing it to (734)-929-9477 or by emailing it to CustomerService@EveristGenomics.com.  Everist Genomics will work directly with your insurance company or Medicare on your behalf.
• Step 3
  Within 3 working days of receiving your completed form, Everist Genomics will provide you and your doctor with written confirmation of your financial benefits and options as well as how to proceed.

For Patients Denied Reimbursement by their Insurance Company:

If your insurance company or Medicare denies payment for your OncoDefender-CRC test, the Everist Genomics Customer Care team will assist you with eligibility for a discounted payment program tailored specifically for you.

In this event a member of the Everist Genomics Customer Care team will contact you to describe the program you are eligible for.  Everist Genomics will provide you and your doctor with written confirmation of your discounted payment program proposal typically within 4 working days of receipt of your AOB.

For Patients with no Insurance or Requiring Financial Assistance:

If you do not have insurance or require financial assistance please obtain and complete the Everist Genomics Financial Assistance (EGFA) form.  To obtain an EGFA form please click here or call the Everist Genomics Customer Care team at 1-855-EVERIST or 855-383-7478 (toll-free).  Everist Genomics will provide you and your doctor with written confirmation of your Financial Assistance Benefits proposal typically within 4 working days of receipt of your EGFA form.

Ordering your OncoDefender-CRC Test:

Your physician will complete the OncoDefender-CRC test requisition form on your behalf and Everist Genomics will conduct your OncoDefender-CRC test.

Results of the OncoDefender-CRC assay are available within 7 to 10 days from the date the tumor sample is received by Everist Genomics.

If you have any questions about the Assignment of Insurance Benefits form, or any aspect of your insurance coverage or the Everist Genomics Financial Assistance program feel free to contact Everist Genomics Customer Care at 1-855-EVERIST or 855-383-7478 (toll-free).

Is OncoDefender Right For You?

When you are first diagnosed with colon or rectal cancer, your doctor needs to assess whether you are at risk of metastasis or tumor recurrence to determine the appropriate treatment plan. Traditionally, doctors assess a patient’s suitability for post-surgical treatment based on standards published in the National Comprehensive Cancer Network (NCCN) guidelines, which considers anatomic tumor features such as tumor size and depth of invasion. While the NCCN guidelines have established an effective pathway for assessing the likelihood of cancer recurrence, doctors and patients must recognize that these assessments are not always definitive or prescriptive.

OncoDefender-CRC can equip your doctor with vital information on your specific cancer.  When analyzed collectively with data from the traditional assessment, OncoDefender-CRC produces a personalized roadmap to guide your physician on treatment choices in light of your risk of cancer recurrence.

You may be a candidate for the OncoDefender-CRC test if you have recently been diagnosed with Stage I/II colon cancer or Stage I rectal cancer, and you and your doctor are making treatment decisions regarding adjuvant chemotherapy.

Getting Tested

How Do I Order OncoDefender-CRC?

Because OncoDefender-CRC is a clinical lab test, it can only be ordered through an authorized healthcare provider. You should discuss with your doctor the possibility of getting tested after being diagnosed with early-stage colon or rectal cancer.

If you and your doctor decide to order the OncoDefender-CRC test, the Everist Genomics Customer Care team will help you determine if the test is covered by your insurance. For patients who are uninsured or whose insurance does not provide adequate coverage, our team provides financial assistance and discounted payment programs to help them receive testing. Based on your individual needs, you may be eligible to have up to 80% of the cost of the OncoDefender-CRC test covered on your behalf by one of the Everist Genomics Financial Assistance programs.

Once you and your doctor have decided to order an OncoDefender-CRC test, your doctor will obtain a tissue sample of your cancer during initial resection surgery, which will arrange to have a sample of the tumor that was removed at the time of surgery submitted to Everist Genomics’ clinical laboratory for testing.

How Can I Discuss OncoDefender-CRC with My Doctor?

When you are talking to your doctor about your colorectal cancer diagnosis, one of the key questions is always about the likelihood of recurrence of your cancer following surgery.  OncoDefender-CRC can provide your doctor with new information about your specific cancer and the likelihood of recurrence.  If your doctor believes that your cancer is likely to recur, he or she may suggest adjuvant chemotherapy to reduce the likelihood. Chemotherapy can be very effective at preventing cancer recurrence, but the decision to undergo or forego this type of treatment should be based on credible, objective information as chemotherapy may cause adverse side effects in patients.

OncoDefender-CRC can help patients and their doctors make more objective decisions about the need for adjuvant chemotherapy by reporting key genetic data that has been validated to accurately predict cancer recurrence.

If you would like your doctor to consider OncoDefender-CRC as part of your recurrence assessment, Everist Genomics can help by providing information about the test to your medical team. For more information, please call 855-EVERIST (855-383-7478).

How Are The Test Results Reported and Analyzed?