Independent Clinical Study Published Demonstrating Clinical Utility of the Paradigm Cancer Diagnostic (PCDx) Test
- July 21, 2016
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An independent, peer-reviewed clinical study published today in Oncotarget entitled “Clinical Benefit of A Precision Medicine Based Approach For Guiding Treatment of Refractory Cancers” provides additional data supporting the clinical utility of the Paradigm PCDx test to significantly help improve outcomes for patients with cancer.
This independent study was performed by the Indiana University Health Precision Genomics Program from April 2014 toOctober 2015. Overall, 168 patients presenting with metastatic tumors that had progressed on at least one line of standard therapy were enrolled. Tumor samples were then submitted for comprehensive molecular testing to help identify actionable and druggable targets. As part of the Indiana University Health Precision Genomics Program, a multi-disciplinary tumor board reviewed all testing results. Of the 168 patients, 101 patients achieved adequate clinical follow-up for analysis.
For each patient, the ratio of progression-free survival (PFS) of the genomically guided therapy divided by the PFS for their prior line was calculated. This ratio, called the growth maturation index (GMI), helps assess whether a patient’s response to new therapy is longer or more durable than the previous therapy. Generally, the PFS is expected to decrease with each subsequent line of therapy. Patients, whose PFS ratio was ≥1.3, or at least 30% longer, were deemed to have a meaningful improvement in PFS. Of the 101 patients that were included in the final analysis, 19 of 44 (43.2%) of patients treated with genomically guided therapy attained a PFS ratio ≥ 1.3 vs. only 3 of 57 (5.3%) treated with non-genomically guided therapy. These results were statistically significant (p < 0.0001).
The most significant observations that typically led to clinical interventions including substantial improvements in progression free survival included DNA mutations in EGFR and IDH1; copy number variation (CNV) in fibroblast growth factor (FGFR) and HER2; IHC positivity for PD-L1 and MET; and messenger RNA (mRNA) overexpression for amphiregulin (AREG), epiregulin (EREG), E-Cadherin (CDH1), hENT1, TOPOIIa, and VEGFA.
“We are excited and encouraged by the results of this initial study performed by our colleagues at Indiana University,” said Dr.David Loesch, Medical Director of Oncology Services at Paradigm. “Since 2010, it has been known that integrating DNA, RNA & protein are critical to more completely assess the context of vulnerability of a patient’s cancer. We look forward to additional clinical collaborations with community and academic teams to continue to prove out the clinical utility of PCDx and further discoveries in targeted drug development.”
PCDx is a comprehensive clinical-grade NGS-based test that is designed to provide physicians and patients with a more targeted, personalized approach to cancer treatment by identifying the underlying genomic and proteomic alterations of a tumors DNA, mRNA & protein. The test interrogates the most relevant genomic targets at over 5,000x average depth of coverage with 72 potential therapeutic associations. Results are typically delivered in 4-5 business days.
Paradigm is a molecular information corporation established to bring cutting-edge diagnostics to cancer patients and industry by providing information about the genomic makeup of the patient’s cancer and potential therapies based on the specific characterization of the patient’s tumor that can impact the patient’s course of treatment. Paradigm’s Next-Generation Sequencing based diagnostic test PCDx provides oncologists and patients with more precise information about the specific cancer pathways in the patient and associations between the pathways and the specific drugs available that can affect the cancer to allow for more effective decision-making. The test is driven by supporting data and literature and provides more choices for patient care than currently available on the market. For more information visit http://www.paradigmdx.com or visit us on Twitter @Paradigm_DX.