Oklahoma-based Progentec Diagnostics develops suite of tools to diagnose and manage painful autoimmune disease
The Lupus Foundation of America estimates there are 1.5 million Americans who are afflicted with lupus, a chronic autoimmune disease in which the patient’s immune system attacks healthy tissue in the body. The results are painful and potentially life threatening. Lupus damages skin, joints and organs, including the kidneys and the heart. Lupus develops in a population that is usually between 15 and 44 years old – mostly women – with symptoms that ebb and flow over time. When the symptoms show up it is known as a lupus “flare.”
Diagnosing and predicting an impending lupus flare is an inexact science, meaning that treatments often begin well after symptoms show up. Oklahoma City-based Progentec Diagnostics, Inc., has developed a trio of tests that can predict a lupus flare weeks in advance, improve accuracy of a lupus diagnosis and monitor effectiveness of the treatment after diagnosis.
“The current test for diagnosing lupus is really old and probably has a 50 to 60 percent predictive value,” said Sanjiv Sharma, Progentec co-founder and chairman of the board. “Whereas, our test, once the data is confirmed in a larger trial, could have over a 90 percent predictive value.”
Progentec licensed technology from the Oklahoma Medical Research Foundation (OMRF) to build the suite of diagnostics. OMRF scientists Judith James, Ph.D., M.D., and Melissa Munroe, Ph.D., M.D., pioneered research that identified biomarkers that could predict a future lupus flare.
“There is a big unmet need in screening the right people and managing them early,” said Progentec CEO and President Mohan Purushothaman, Ph.D. “There is no good screening test to classify whether a patient has lupus or not. Most people only know they have lupus when they get a flare or when their doctor finds something indicative of lupus as part of their physical.”
Founded in 2015, Progentec completed a $1.25 million financing round in 2017 that was led by i2E, Inc., OCA Ventures and Mayo Clinic Ventures. It also was awarded a grant from the Oklahoma Center for the Advancement of Science and Technology (OCAST) to support one of its studies.
“We are working very closely with i2E to prepare us for the next round of funding,” Purushothaman said. “We have initiated two studies to further refine our algorithms and ready them for commercial launch.”
Progentec is in the process of setting up its own laboratory and obtaining CLIA certification by mid-2018. CLIA is an acronym for Clinical Laboratory Improvement Amendments through which the Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S.
“In order to go through the CLIA certification process and to ensure that our technology is supported and accepted by the medical community as well as the payer community, we are planning multiple studies in the near future,” Purushothaman said.
Progentec’s flare prediction test could be available by September. Its Disease Activity Index test should be available by late 2019 and a Lupus Classification test by 2020.
“Our goal is to complete the retrospective study at OMRF by June this year,” Purushothaman said. “Our prospective study for which 100 patients will be recruited at OMRF and Mayo Clinic is expected to finish by June 2019.”
Armed with more accurate tests of identifying and prediction lupus flares, physicians will be able to prescribe more effective treatments to combat the disease, said Manu Nair, vice president of technology ventures at OMRF. Lupus patients will see an improved quality of life.
“Doctors that we spoke to love this candidate test, because they can actually have a good tool for their patients, and to manage the patients and give the right medication,” Nair said. “If you can predict flare and dampen it, you avoid that hospital cost, and long term you could avoid organ damage in general, and related medical needs like kidney transplant.”
Progentec has achieved significant development milestones to quickly advance the diagnostics in part because of support from Oklahoma’s economic development environment, Purushothaman said.
“i2E has been a wonderful support for us, and we continue to work with them as we grow,” he said. “The research and scientific team at OMRF have been phenomenal in their R&D efforts. We have also seen other agencies in Oklahoma such as OCAST play their part effectively in nurturing companies like ours.”
The company is on track to deploy a groundbreaking diagnostic with the potential to improve the lives of millions of people worldwide.
“We are not creating another small diagnostic,” Sharma said. “Our vision is a complete solution through state-of-the-art diagnostics helping right from diagnosing lupus, to management of lupus flare and help in monitoring disease and effectiveness or lack of effects of various treatments.”
This story was originally published in The Oklahoman. It is published here with permission.