Centers for Disease Control and Prevention (CDC) defines clinical utility as a test’s ability to significantly improve outcomes such as improved survival.1 In this case, clinical utility is the impact on clinical decision-making, that is, the decision about using adjuvant chemotherapy. As noted by Simon et al.,2 the medical indication for using the test is clear and the magnitude of outcomes or treatment effects associated with different test results are sufficiently great as to influence treatment decisions.
ColoPrint has demonstrated improved clinical outcomes. Low Risk ColoPrint patients had good outcomes independent of stage or chemotherapy treatment (90.1% 3-year Risk Free Survival (RFS) for treated patients, 91.4% for untreated patients) while ColoPrint High Risk patients treated with adjuvant chemotherapy had 3-year RFS of 84%, compared to 70.1% 3-year RFS in untreated patients (p=0.026).3
ColoPrint is more accurate at identifying Low Risk patients than MSI-H status and other traditional clinical assessment factors, and ColoPrint identifies more patients as Low Risk than either MSI-High or traditional clinical assessment factors. Clinical assessment classifies approximately half the patients as low risk and approximately half as High Risk, whereas ColoPrint classifies 65-75% as Low Risk. One physician noted that using ColoPrint classifies 30% of ASCO High Risk into the Low Risk group. This is an extremely important and valuable feature that only ColoPrint offers, since follow up of colon cancer patients is very expensive with its increased frequency of MRI scans and colonoscopies. Being able to avoid chemotherapeutic treatment of patients in the Low Risk group avoids treatment costs, and the costs of treating adverse effects.
When used as intended, ColoPrint provides significant benefit to patients, physicians, payers and healthcare systems utilizing it because it:
Agendia’s extensive clinical trials and research collaborations have produced numerous retrospective and prospective validation studies over the past decade, which have enabled the successful commercialization of genomic microarray assays, such as the FDA-cleared 70-gene MammaPrint profile. Recently published studies further support the prognostic and predictive clinical utility of MammaPrint for early stage breast cancer patients, and large, multi-institutional clinical trials, such as MINDACT and ISPY-2, can be expected to expand the assay’s clinical importance and indications for use. Recently, the five year prospective results of the RASTER study were published indicating that chemotherapy may be safely withheld in Low Risk breast cancer patients.
Published studies continue to support the strong prognostic and predictive clinical utility of Agendia’s genomic assays and ongoing large, multi-site clinical trials such as MINDACT seek to expand clinical indications for use.
Enrollment for the prospective PARSC trial for ColoPrint, an assay that evaluates recurrence risk in stage II and III colon cancer patients has recently been completed.
Currently, Agendia is enrolling institutions and cancer centers worldwide in the following studies:
Early stage breast cancer
Early stage colon cancer
With Agendia’s state-of-the-art genomics laboratories in California and the Netherlands, the company is actively engaging academic centers, medical institutions and pharmaceutical companies in clinical trials collaboration opportunities, globally.
Agendia’s mission is to provide colon cancer patients access to the ColoPrint colon cancer recurrence signature, to help physicians and patients make more informed, personalized therapy decisions. Agendia understands that costs associated with the patient’s diagnosis, treatment and management of their colon cancer can possibly pose a financial hardship and may influence a patient’s decision in selecting diagnostic and treatment options.
Agendia will bill insurance companies on behalf of insured patients throughout the United States. Based on the patient’s specific benefit level, the insurance companies may pay a portion or all of the cost submitted for ColoPrint. Patients will be held responsible for their co-insurance, co-pay or deductible per their health insurance policies.
Agendia is a compassionate company offering a wide range of financial assistance programs based on individual financial status. Agendia’s Reimbursement Assistance Program (ARAP) includes the following to meet the patient’s financial needs:
Agendia remains dedicated to providing physicians and their patients the very best in diagnostic testing and customer support. For questions regarding a patient’s specific level of coverage, please contact Agendia at 888-363-7868 or firstname.lastname@example.org.