Systems Diagnostics, or SysDx™, will be a novel diagnostic tests that can consist of “multi-omic” biomarkers selected through a rigorous Big Data analysis of a patient’s biological profile including genomic, epigenomic, transcriptomic, proteomic, metabolomic and electronic medial record information. From this analysis, Selventa will generate a differentiated and clinically-relevant report that physicians and patients can use to improve therapy selection.
“SysDx testing is a much needed progression from ‘single-omic’ tests that today are largely limited to the analyses of genetic aberrations in a patients disease,” said Dr. David de Graaf, President and CEO, Selventa. “Because the molecular drivers of disease are manifested across thousands of interrelated biochemical pathways, it is vital that a diagnostic be able to test for a more comprehensive set of disease-relevant biomarkers. SysDx testing promises to capture a more detailed profile of a patient’s disease leading to more informed healthcare decisions.”
Selventa is currently focusing its SysDx development in autoimmune and cancer. These complex multi-factorial diseases require more than genetic information alone to gain an effective diagnosis that can guide treatment.
Dr. de Graaf added, “SysDx is a natural outgrowth of our successful 10-yr heritage as a leader in systems biology and biomarker identification for pharma and biotech. Our ‘Big Data’ analytics and algorithms uniquely integrate, process and analyze different molecular information from thousands of patients to identify biomarkers. This unique capability is the foundation for SysDx tests that will have stronger validation, higher reliability and provide superior predictive and prognostic capabilities.”
Selventa has achieved proof of concept for multiple SysDx tests in:
• Rheumatoid Arthritis (RA)
• Inflammatory Bowel Disease (IBD)
o Crohn’s disease
o Ulcerative colitis
• Multiple cancers
Selventa’s lead product will be Clarify-RA, a SysDx test that will be able to predict which patients suffering from RA will not respond to the standard of care anti-TNF therapy.
RA is a chronic, debilitating disease that affects an estimated 2 million people in the United States. It is also an expensive disease to treat, costing the healthcare system on average USD 20,000 per patient every year. In moderate to severe RA patients, only 40% of patients gain a clinically significant benefit from the anti-TNFs.
Dr. de Graaf added, “A large unmet medical need is to identify early if a patient is a non-responder to the standard of care therapy in the care cycle. It is estimated that 50% of all prescribed drugs lack efficacy, or worse are dangerous to the patient. A SysDx that can identify non-responders to major classes of drugs will benefit the patient and also deliver tangible cost benefits to payers. Furthermore, this increased knowledge about patients will help pharmaceutical companies to re-position their drugs.”