NEW YORK (GenomeWeb) – Predictive Technology, a biotech holding corporation based in Salt Lake City, is commercializing an assay that uses genetic biomarkers to determine whether a woman is at risk of developing endometriosis as well as to diagnose the disease and personalize treatment guidance.
Endometriosis is one of the most common women's health disorders, causing up to 10 percent of reproductive-age women to experience painful periods and potential infertility. Diagnosis can elude patients for decades, in part because exploratory surgery is considered the ultimate diagnostic method.
According to Bradley Robinson, CEO of Predictive Technology, the firm's endometriosis assay was originally developed and patented by Kenneth Ward at Juneau Biosciences. Predictive Technology licensed the assay in 2016 and plans to launch a first product sometime this year, initially in the infertility space, Robinson said in an interview, and hopes to ultimately provide its test to any woman with infertility, chronic pelvic pain, or severe PMS.
The assay uses either blood or saliva samples and employs PCR to detect a set of biomarkers that the firm purports to be both diagnostic and prognostic of endometriosis. In a 2014 PLoS One study, the Juneau team found endometriosis associated with CNVs. An earlier GWAS study had shown a relationship with some SNPs, while a Reproductive Sciences article published last year described a panel of four genes associated with endometriosis that are potential regulators of mesothelial barrier integrity, suggesting a mechanism for the disease.
Predictive Technology has also been developing an endometriosis therapeutic, and has been issued a patent for one comprising progestin and progesterone, cannabis, and an optional nonsteroidal anti-inflammatory component.
The Predictive Technology test will enable the firm to predict how well patients are going to respond to different therapies, similar to a pharmacogenomics test, Robinson added. "We use the diagnostic to understand the patient and what therapy is best for her, not simply for diagnosing the patient," he explained.
Specifically, the company will use data analytics to gauge the interaction between the individual and the type of disease to guide treatment more appropriately, both its own therapeutic as well as other treatments like hormonal birth control, GnRH agonists such as Lupron, or possibly a GnRH antagonist from AbbVie called Elagolix that is currently before the US Food and Drug Administration.
Endometriosis is a progressive disease in which the endometrial tissue that normally lines the uterus begins to grow outside of the uterus. Surgery — either laparoscopy or laparotomy — is currently the only way to definitively diagnose the disease, according to the National Institutes of Health.
Robinson said the prognostic aspect of the company's test could lead to future development of a "screen your teen" product, which could be used to uncover risk of endometriosis prior to puberty, well before damage and scarring of the disease causes symptoms of painful periods and potential infertility.
Predictive Technology Group is a life sciences holding company founded in 2013. It currently has two wholly owned subsidiaries — Predictive Biotech and Predictive Therapeutics — and is traded on the OTC market.
The biotech branch includes a line of regenerative medicines using placental stem cells and a portfolio of assets related to spine health, including LDT molecular diagnostics for degenerative disk disease and scoliosis.
The firm's therapeutics branch initially set out to develop a therapeutic for endometriosis. But realizing the key to the disease is early intervention, the company then brought in the lab-developed diagnostic from Juneau Biosciences and acquired LifeCode Genetics in 2016.
To support its diagnostics push, the firm has also brought in a number advisors and executives with high profiles in the endometriosis space. For example, Hugh Taylor, chair of obstetrics, gynecology, and reproductive sciences at Yale School of Medicine as well as chief of obstetrics and gynecology at Yale-New Haven Hospital, joined the firm's scientific advisory board earlier this month. Predictive Technology also brought in Michael Dey, former president of the women's health division at Wyeth, to be a board member and the CEO of the therapeutics group.
The company has also appointed John Sorrentino, the current vice president and COO of vaccine research and development at Pfizer, as chair of its scientific advisory board, and added Greg Prince, a co-founder and CEO of Virion, and John Nelson, a former president of the American Medical Association and the Utah Medical Association, to the board as well.
The company has also filed a letter of intent to acquire FlagshipHealth Group, Robinson said. That Minnesota-based firm is headed by Tim Lacy, whose experience includes senior executive positions at UnitedHealth Group and Walgreens, and William McGuire, the former chairman and CEO of UnitedHealth Group, and provides consulting services and sales support.
This new acquisition helps the team "understand all the stakeholders in endometriosis," Robinson said, to allow the firm to have a comprehensive solution, from payors to patients.
A few other firms are known to be looking into endometriosis diagnostics using various methods. For example, MDNA Life Sciences formed a collaboration last year with the University of Oxford to further develop and validate its mitochondrial DNA-based blood test for endometriosis and plans to launch a test this year, while VolitionRx reportedly entered into an agreement, also with the University of Oxford, to develop a test using nucleosomes.