OncoDefender™-CRC Prognostic Test Questions and Answers for Physicians [March 2011]
[ OncoDefender – Colorectal Cancer (CRC) Prognostic Test: Scientific and Performance Background in Question and Answer Format ]
Summary: 1. OncoDefender™-CRC is the world’s only molecular prognostic test capable of accurately predicting the risk of recurrence of cancer in patients previously treated with surgical resection of a Stage I/II colon cancer tumor or Stage 1 rectal cancer tumor. No other currently available molecular diagnostic test approaches the performance capabilities of OncoDefender-CRC in this regard. 2. Patients identified by OncoDefender-CRC at high-risk of cancer recurrence may benefit from adjuvant therapy or other more aggressive treatment options.
Independent studies 1 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.
3. The OncoDefender-CRC test will help physicians make appropriate postsurgical decisions about the need for adjuvant therapy. 4. Regardless of your patient’s insurance coverage or financial status, the Everist Genomics Customer Care team will assist your patient in obtaining the testing they need. Everist Genomics will rapidly help your patient verify whether or not their insurance covers the test and will bill the insurance company on your patient’s behalf. In the unlikely event that your patient’s insurance company denies coverage, or if they require financial assistance, Everist Genomics also has a generous financial assistance program. Qualifying patients are eligible to have up to 80% of the cost of the OncoDefender-CRC test covered through one of the Everist Genomic Financial Assistance programs.
1
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. Page 2 of 17
Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
1. What is the medical need for OncoDefender-CRC?
OncoDefender-CRC will help physicians make patient management decisions that promptly and reliably direct the most effective treatment to those individual Stage I/II colon cancer and Stage I rectal cancer patients at high risk for tumor recurrence, while minimizing the exposure of low-risk patients to unnecessary, costly, and potentially toxic chemotherapy and/or radiotherapy. Colorectal cancer (CRC) is one of the major causes of cancer death worldwide, accounting for more than 150,000 new cases and 55,000 deaths in the United States every year and 125,000 deaths each year in Europe. (Source: Wolpin BM, Meyerhardt JA, Mamon HJ, Mayer RJ. Adjuvant treatment of colorectal cancer. Cancer J Clin 57:168–185, 2007.) To date, surgery, followed by adjuvant chemotherapy when appropriate, is the mainstay of therapy for patients with localized disease. Of the estimated 68,000 patients that will be diagnosed with early-stage colorectal cancer this year in the US (approximately 22,000 Stage I, and 46,000 Stage II), 90% of those with Stage I and 70% of those with Stage II likely will be cured by surgery alone. The remaining 10% of those with Stage I (about 2,200) and 30% with Stage II (about 14,000) will ultimately recur and die of advanced colorectal cancer, consequent to undetected tumor remaining following definitive surgery. (Source: El-Deiry WS. Colon cancer, adenocarcinoma, 2006, http://emedicine.medscape.com/article/277496overview) Many of these latter patients may have been cured or had their lives prolonged had they been more accurately identified as being at ‘high-risk’ for tumor recurrence and received post-surgical resection adjuvant therapy. Identifying those patients at high-risk for colorectal cancer recurrence can reduce mortality, morbidity and cost of care. In addition to improved overall survival rates, accurate risk stratification of colorectal cancer patients can have subtantial economic benefits in patients identified as highrisk or low-risk for recurrence: For example, preventing even a single disease recurrence through targeted administration of adjuvant therapy yields an overall savings of greater than $200,000 for the healthcare system per patient. Accurate and early identification of patients at low-risk for recurrence greatly improves quality of life by avoiding the debilitating and potentially life threatening effects of chemotherapy (e.g. gastrointestinal illness, liver and kidney pathology, peripheral nerve damage, etc.) and can save the healthcare system in excess of $50,000 for each avoidance of unnecessary post-surgical therapy.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
2. What is the OncoDefender-CRC technology? The OncoDefender-CRC test is a prognostic gene-based laboratory assay which will help guide treatment decisions following tumor resection in patients with a pathologically confirmed Stage I/II colon cancer or Stage I rectal cancer diagnosis. Based on Everist Genomics patented Evolver™ platform, the OncoDefender-CRC assay evaluates the expression levels of 5 specific genes (identified by Everist Genomics as predictors of recurrence) from colorectal cancer tissue samples with a proprietary computational rule. The result of this is a prediction of risk of recurrence within 3 years after surgery for Stage I/II colon cancer patients and Stage I rectal cancer patients. 3. What are the performance characteristics of the OncoDefender-CRC assay? Performance in Stage I Colorectal Cancer Patients: Because of the limitations of legacy testing methods (refer to table below) for Stage I colorectal cancer and the inability of legacy tests to accurately assess risk of recurrence, adjuvant therapy is not provided to Stage I patients; the Everist Genomics OncoDefender-CRC test predicts the risk of recurrence in these patients and represents a major advance for Stage I colorectal cancer patients:
Relative Performance in Stage 1 Colorectal Cancer Patients
Everist Genomics OncoDefender™CRC Test
Current Pathology Standard of Care
Sensitivity
69%
No capability to perform
First to market, major advance in sensitivity
Specificity
88%
No capability to perform
First to market, major advance in specificity
Positive Predictive Value (PPV)
82%
No capability to perform
First to market, major advance in PPV
Negative Predictive Value (NPV)
78%
No capability to perform
First to market, major advance in NPV
79%
No capability to perform
First to market, major advance in accuracy
Accuracy
OncoDefender™CRC Competitive Advantage
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
Performance in Stage II Colon Cancer Patients: For Stage II patients, the Everist Genomics OncoDefender-CRC test represents a major advance for physicians and patients relative to currently available testing methods: Relative Performance in Stage 2 Colon Cancer Patients
Everist Genomics OncoDefenderCRC Test
Current Pathology Standard of Care
Sensitivity
70%
<30%
Major advance in sensitivity
Specificity
55%
25%
Major advance in specificity
Positive Predictive Value (PPV)
51%
45%
Significant advance in PPV
Negative Predictive Value (NPV)
73%
<26%
Major advance in NPV
Accuracy
61%
<10%
Major advance in accuracy
OncoDefender-CRC Competitive Advantage
Everist Genomics OncoDefender-CRC Prognostic Test Compared to Currently Available Molecular Diagnostic CRC Tests: The OncoDefender-CRC test has major advantages over other molecular diagnostic CRC tests: I.
Currently available molecular diagnostic tests are typically priced at more than $3,000 per patient tested. However, this 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 this other test will get no usable results, while having pre-paid over $3,000 each. The OncoDefender-CRC test produces zero no-call results and provides an assessment of risk of recurrence for every patient tested
II.
Everist Genomics has succeeded in creating an important advance in the assessment of risk of recurrence of colorectal cancer which overcomes limitations of currently available tests and exceeds the performance characteristics achieved by applying standard of care guidelines alone.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
4. How well do OncoDefender-CRC results correlate with a patient’s likelihood of cancer recurrence? OncoDefender-CRC was developed through extensive clinical research and assay validation studies involving over 500 patients from around the world. According to independent biostatistical review, OncoDefender-CRC test results correlate well with colorectal cancer recurrence. The clinical data indicate that the performance characteristics of the OncoDefenderCRC test are superior to other methods currently in use to predict recurrence. Furthermore, studies demonstrate that high-risk OncoDefender-CRC results correlate with cohorts with higher risk of colorectal cancer recurrence within 3 years of surgery, while low-risk results correlate more closely with those patients without recurrence in 3 years.
As a further indication of the overall accuracy and robustness of OncoDefender-CRC, the test does not report indeterminate or “no-call” results from any samples that meet quality acceptance and processing criteria. 5. How will the OncoDefender-CRC technology contribute to the clinical management of my patients? Clinicopathologic staging of colorectal cancer, most commonly using the American Joint Committee on Cancer TNM Staging System, is currently the prognostic “gold standard” for clinical management of colorectal cancer (Source: Colon and Rectum. In: AJCC Cancer Staging Manual, 7th ed. Edge, S.B.; Byrd, D.R.; Compton, C.C.; Fritz, A.G.; Greene, F.L.; Trotti, A. (Eds.) 2010, New York: Springer-Verlag (www.cancerstaging.net) ISBN 978-0-387-88440-0.) This system only considers anatomic tumor features, categorizing the size and depth of invasion of the primary tumor (T), the extent to which regional lymph nodes (N) are involved and the presence or absence of distant metastases (M). TNM staging, however, fails to take into account a cancer’s underlying molecular and genomic heterogeneity, characteristics that are increasingly being recognized as key to fully understanding the natural history of the disease. OncoDefender-CRC is the world’s only molecular diagnostic test capable of accurately 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. No other currently available molecular diagnostic test approaches the performance capabilities of OncoDefender-CRC in this regard. Benefits for Clinical Management of Stage I Colorectal Cancer Patients: As depicted in the illustrations which follow, OncoDefender-CRC will help physicians make patient management decisions that promptly and reliably direct the most effective treatment to those individual Stage I colorectal cancer patients at high risk for Page 6 of 17
Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
tumor recurrence, while minimizing the exposure of low-risk patients to unnecessary, costly, and potentially toxic chemotherapy and/or radiotherapy. (Comparison of OncoDefender-CRC with standard pathologist assessment procedures):
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
Benefits for Clinical Management of Stage II Colon Cancer Patients: OncoDefender-CRC will also help physicians make patient management decisions that promptly and reliably direct the most effective treatment to those individual Stage II colon cancer patients at high risk for tumor recurrence, while minimizing the exposure of low-risk patients to unnecessary, costly, and potentially toxic chemotherapy and/or radiotherapy. (Comparison of OncoDefender-CRC with standard pathologist assessment procedures):
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
Benefits Relative to Other Currently Available Molecular Diagnostic Tests: OncoDefender-CRC will also help physicians make patient management decisions that promptly and reliably direct the most effective treatment to those individual Stage II colon cancer patients at high risk for tumor recurrence, while minimizing the exposure of low-risk patients to unnecessary, costly, and potentially toxic chemotherapy and/or radiotherapy. (Comparison of OncoDefender-CRC with other currently available molecular diagnostic tests):
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
6. How does the OncoDefender-CRC test work? OncoDefender-CRC assay protocol is summarized below: a. Either formalin-fixed paraffin-embedded (FFPE) slides or blocks are accepted. If blocks are sent, slides are prepared using 5-micron slices from the blocks. b. Slides are reviewed by an independent pathologist at Everist genomics to verify tissue type, tumor quantity, and location of tumor on the slides. c. The FFPE tumor tissue affixed to the slides is scraped into RNAse-free microfuge tubes and deparaffinized in xylene. d. RNA is extracted and purified following the manufacturer’s standard protocol for a RecoverAll™ Total Nucleic Acid Isolation Kit (Applied Biosystems/Ambion, Austin, TX). e. Purity and quantity of RNA is determined by measuring UV absorption ratios of 260/280 and 230/260 nM using a Nanodrop 1000 UV/Vis spectrophotometer. f. A minimum of 100 ng of RNA is transcribed into single stranded cDNA using a High Capacity cDNA archive kit (Applied Biosystems, Inc., Foster City, CA), employing random hexamers and poly (dT) as primers. cDNA archive plates are either used immediately for RT-PCR or sealed and stored at -80o C. g. Gene expression is assayed using TaqMan® custom array 384-well micro fluidic cards that allow 384 simultaneous real-time PCR reactions. One Hundred ng of cDNA per 48 wells are applied to the cards and all assays are performed in duplicate according to instructions of the manufacturer using an Applied Biosystems 7900HT Fast Real-Time PCR System. Output data are in number of PCR cycles (CT) needed to reach a constant threshold set at 0.2. h. The gene expression data is processed to determine risk of cancer recurrence based on comparison to results of studies performed by Everist Genomics. 7. For which patients is OncoDefender-CRC appropriate? OncoDefender-CRC is a prognostic tool that is designed to be used after surgery for Stage I/II colon carcinoma and Stage I rectal carcinoma patients. 8. Should the results of the OncoDefender-CRC test be used to delay or cancel any treatment? OncoDefender-CRC is a prognostic tool intended to support treatment decisions and should be used in conjunction with, not in lieu of, standard medical treatment guidelines.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
9. Has OncoDefender-CRC been approved for use in the U.S.? OncoDefender-CRC is registered and certified through Everist Genomics highcomplexity clinical reference laboratory that is regulated by the federal Clinical Laboratory Improvement Amendments (CLIA) guidelines established in 1988. Independent research and validation studies have already been performed on OncoDefender-CRC for Stage I/II colon cancer patients and Stage I rectal cancer patients. OncoDefender-CRC is currently commercially available for this indication. OncoDefender-CRC was developed by Everist Genomics. 10. Is OncoDefender-CRC covered by health insurance? Regardless of your patient’s insurance coverage or financial status, the Everist Genomics Customer Care team will assist your patient in obtaining the testing they need. Everist Genomics will help your patient verify whether or not thier insurance covers the test and will bill the insurance company (or MediCare) on behalf of your patient. In the unlikely event that your patient’s insurance company denies coverage, or if your patient requires financial assistance, Everist Genomics also has a generous financial assistance program. Qualifying patients are eligible to have up to 80% of the cost of the OncoDefender-CRC test covered through one of the Everist Genomic Financial Assistance programs. 11. Is OncoDefender-CRC a genetic test? While OncoDefender-CRC does measure certain gene expression levels, it is not a test for hereditary or genetic predisposition of any disease or disorder. The gene expression values are combined mathematically in a unique way to produce a relative measure of risk of recurrence; actual genetic information is not reported. 12. Who developed OncoDefender-CRC? The OncoDefender-CRC technology is derived from research and commercialization development by Everist Genomics in Ann Arbor, MI. The company was formed in 2002 and is privately owned.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
13. How was the OncoDefender-CRC assay developed and validated? The OncoDefender-CRC development and validation process followed eight steps: a. Definition of specific aim b. Selection of genes for generation of a custom colorectal cancer specific gene panel c. Selection of housekeeping genes d. Specification of sample and data inclusion criteria e. Selection and design of scientific components f. Processing and normalization of data g. Data analysis and development of predictive rule Each of these steps is summarized below: a. Definition of specific aim After confirming medical need, the aim of Everist Genomics was to develop a molecular diagnostic laboratory test (OncoDefender-CRC) that determines the expression level of certain genes found in excised primary tumor tissue from CRC patients and applies those values to a proprietary rule that accurately predicts whether or not CRC in a particular patient is likely to recur within 3 years. b. Selection of genes for generation of a custom colorectal cancer specific gene panel An initial custom colorectal cancer (CRC) panel of genes was selected based on information from the scientific literature according to the following criteria: A core set of genes that are generally well-known to be associated with tumorigenesis, tumor progression and metastasis regardless of tumor type. Many of these genes are well-known oncogenes and proto-oncogenes. Genes that encode for key regulatory proteins in cellular processes known to be greatly utilized by tumors including cell cycle progression, angiogenesis, survival and apoptosis. Genes reported to be specifically involved in the initiation and progression of colorectal cancer.
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Genes that have been reported to be prognostic for patients with colorectal cancer in terms of aggressiveness, recurrence and patient survival. Genes that have been shown to be predictive or influence tumor response to current chemotherapies for colorectal cancer. Genes that have been shown to be differentially expressed between normal and malignant colorectal tissue. c. Selection of reference genes The data used for development of OncoDefender-CRC was normalized using five reference genes to correct for differences that might arise from technical variability and deviation in RNA quality and quantity in each assay. Reference genes were selected from 9 candidates that are among those wellknown in the literature as constitutively expressed genes in colorectal cancer and other tissues. The five reference genes selected for the prognostic test showed the lowest levels of expression variability out of the 9 candidates among the patient specimens tested as determined by methods using the software packages GeNorm, Bestkeeper, and Normfinder. d. Specification of sample and data inclusion criteria The following minimal criteria were set for acceptance of tissue samples, RNA, and data for analysis: Tissue samples were required to contain at least 50% tumor of the correct diagnosis. The concentration of extracted RNA was required to be at least 10 µg/µl. Extracted RNA was required to have UV absorption ratio at 260/280 nM of 1.8 or higher. Genes that showed little or no amplification during the PCR process in one or both replicates were not included in the analysis. Based on the increased variation in higher CT numbers, values above 35 were considered unreliable and not used in the analysis. Out of 417 initial genes, certain transcripts were not expressed at all or had CT values greater than 35 in the majority of samples. Genes were included in the analysis only if they were expressed with CT values <35 in 80% of the samples.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
RNA integrity has been shown to dramatically influence results from PCR analyses where CT values rise as RNA degradation increases. It follows, then, that the normalization factor used in this analysis (i.e. the average CT of the 5 house-keeping genes) would rise or fall with the RNA degradation and could be used as an indicator of sample integrity. Based on prior data for expression of the 5 house-keeping genes in colorectal cancer tissue, an upper limit of 29.087 was set for the average of these 5 genes. Thus, any sample with an average house-keeping gene CT above this threshold was eliminated from consideration. e. Selection and design of major scientific components The appropriate mRNA reference sequence (REFSEQ) accession number was identified for each gene and the consensus sequence accessed through the NCBI Entrez nucleotide database. RT-PCR primers and probes were designed by Applied Biosystems (Foster City, CA). Amplicon sizes were kept to a minimum with most being less than 100 bases in length. RNA was extracted and purified from FFPE tissue using the RecoverAll™ Total Nucleic Acid Isolation Kit (Applied Biosystems/Ambion, Austin, TX). FFPE tumor tissue affixed to glass slides was scraped into RNAse-free microfuge tubes using a disposable scalpel. The tissue was deparaffinized in xylene and RNA extracted as described by the manufacturer’s standard protocol. Purity and quantity of RNA solutions were determined by measuring UV absorption ratios of 260/280 and 230/260 nM using the Nanodrop 1000 UV/Vis spectrophotometer. A minimum of 100 ng of RNA was transcribed into single stranded cDNA using the High Capacity cDNA archive kit (Applied Biosystems, Inc., Foster City, CA), employing random hexamers and poly (dT) as primers. cDNA archive plates were either used immediately for RT-PCR or sealed and stored at -80oC. Gene expression was assayed using TaqMan® custom array 384-well micro fluidic cards that allow 384 simultaneous real-time PCR reactions. 100 ng of cDNA per 48 wells were applied to the cards, and all assays were performed in duplicate according to instructions of the manufacturer using the Applied Biosystems 7900HT Fast Real-Time PCR System. Output data are in number of PCR cycles (CT) needed to reach a constant threshold set at 0.2.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
f. Processing and normalization of data Expression data for each gene was produced in duplicate as CT values. Each pair of individual gene replicates was inspected for congruence, and a correlation coefficient was generated for each replicate set of genes. The replicates were averaged and the resulting values used in the normalization process. The data were normalized by subtracting the CT for each rule gene (RG CT) from the average of the 5 reference genes (Ave. 5HK CT). Since CT values are expressed as logarithmic numbers to the base 2, the data was linearized by taking the antilog, and the result was scaled by a selected factor. g. Data analysis and development of predictive rule The predictive rule within OncoDefender-CRC was developed using a proprietary machine learning technique based on genetic programming (GP). Gene expression values as assayed by RT-PCR were used to classify the primary tumor tissue samples into those associated with recurrence within 3 years and those from patients that did not recur. GP uses the available data to produce a set of classifiers ("rules") that are optimized in an iterative fashion through successive retention of the better performing rules. The predictive rule and the OncoDefender-CRC assay process have been validated through clinical study which is summarized in a presentation given at th the ASCO GI Symposium January 18 2011. 14. How do I order the OncoDefender-CRC test and how soon are results reported? The OncoDefender-CRC test process requires either 1 formalin-fixed, paraffinembedded (FFPE) tissue block or 15 unstained slides from the patient’s resected tumor. Results of the OncoDefender-CRC test are typically available within 10 business days from the date the sample and completed Test Requisition Form are received at Everist Genomics. To order OncoDefender-CRC: a. Obtain free sample collection and pre-paid mailing kits by contacting Everist Genomics through our website at www.EveristGenomics.com. When ordering a mailer, please specify sample type (slides or block). b. Affix a bar code label from the collection/mailing kit to the OncoDefender-CRC Test Requisition Form. Complete the Test Requisition Form and send to Everist Genomics.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
c. Forward the collection/mailing kit and a copy of the Test Requisition Form to your Pathologist. (If you have included a Pathologist on the Test Requisition Form, you may also request that Everist Genomics fax a copy of the order form to them.) d. Your Pathologist will prepare and package the sample materials and send them to Everist Genomics using the pre-paid collection/mailer kit. 15. What are the OncoDefender-CRC tissue sample requirements? We accept either a formalin-fixed, paraffin-embedded (FFPE) tissue block or 15 unstained slides. If sending a block, please select one with the greatest amount of invasive cancer and related stroma. Everist Genomics will return any unused tissue from this block to the Pathologist. If sending tissue slides, please prepare 15 slides containing unstained FFPE tissue that, when taken together, provide a total of at least 375 sq mm of colorectal tumor foci (i.e., 25 sq mm tumor/slide) and that are 5 microns thick. Affix a bar code label from the collection/mailing kit to each block or slide sample. These labels must be included and must match the Test Requisition Form label. Further detailed recommendations for obtaining, preparing and shipping samples can be found in the Ordering Information section of the Everist Genomics website at www.everistgenomics.com. 16. What is reported from the OncoDefender-CRC test and how do I get the results? The OncoDefender-CRC results report includes an indication of risk for cancer recurrence within 3 years of surgery (resection) relative to results obtained in the clinical validation study. A sample report is available. Reports are available by fax, overnight mail, or email to the ordering physician and any other physicians or health care providers identified on the Test Requisition Form. The Test Requisition Form provides options for you to select your preferred reporting method. For more information about OncoDefender-CRC, please contact Frank Urban, Director of Medical Marketing and Customer Support, at (734) 335-0730 or email furban@everistgenomics.com.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax
17. What is reported from the OncoDefender-CRC test and how do I get the results? Regardless of insurance coverage or financial status, the Everist Genomics Customer Care team will assist patients in obtaining the testing they need. We will directly bill insurance companies on behalf of insured patients and will accept insurance payments as payment in full with a signed Patient Information and Assignment of Benefits form (AOB). Everist Genomics also has a financial assistance program for those patients that qualify based on financial eligibility. Qualifying patients may be eligible to have 80% of the cost of the OncoDefender-CRC test covered through one of the Everist Genomic Financial Assistance programs. Within 3 to 4 working days of receiving the patient’s application for testing, Everist Genomics will provide the patient and their doctor with written confirmation of their financial benefits.
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Everist Genomics, Inc. ▪ 401 W. Morgan Road ▪ Ann Arbor, MI 48108 ▪ (734) 929 9475 tel ▪ (866) 793-9041 fax