HTG and OvaGene partner on gynecologic cancer tests
Companies establish manufacturing supply agreement
TUCSON, Ariz.—Each year sees well over 80,000 women in the United States alone receive diagnoses of gynecologic cancer: 52,000 cases of endometrial cancer, 22,000 cases of ovarian cancer and 12,000 cases of cervical cancer. This spring saw HTG Molecular Diagnostics Inc. (HTG) and OvaGene Oncology—which boasts being “entirely dedicated to helping women with gynecologic cancers by providing their treating oncologists with molecular tests developed using the latest advancements in gene-based diagnostics”—enter into a manufacturing supply agreement where OvaGene will design and develop their proprietary gene expression assays on HTG’s fully automated, extraction-free Edge Platform.
According to the companies, the HTG Edge System is the only extraction-free, automated gene expression platform that delivers affordable, multiplexed results on lysed samples in less than a day. The Edge System’s multiplexing capability, utilizing only one five-micron-thick formalin-fixed, paraffin-embedded section, provides a unique solution for the clinical laboratory professional.
“We recognized right away that HTG’s technology would help us improve our workflow and reduce turnaround time to our customers and ultimately patients while providing superior quality data. In addition, the system will allow us to expand our specimen type to ascites and smaller samples such as biopsies,” said Frank Kiesner, CEO of OvaGene, in a news release about the deal.
For his part, HTG CEO TJ Johnson said, “We are thrilled to partner with OvaGene as they commercialize these novel molecular tests to make a difference with cancer patients.”
Arizona-based HTG Molecular Diagnostics’ mission is to provide simple, cost-effective solutions for accurate RNA testing. In 2013 the company commercialized its Edge instrument platform and a portfolio of mRNA assays that leverage HTG’s proprietary nuclease protection chemistry. The capability of the Edge System has been expanded to fully automate sample and targeted library preparation for next-generation sequencing.
Irvine, Calif.-based OvaGene is a molecular diagnostics company dedicated to improving cancer care and outcomes for gynecologic cancer patients through the development of novel gene-based assays. Through its CLIA lab, the company offers a menu of tests including gene-based diagnostic assays to assist physicians in the prognosis of gynecologic cancers as well as therapy selection, including radiation and chemotherapy.
In other April HTG news, the company announced that Dr. Patrick Roche had joined the company as senior vice president for in-vitro diagnostic (IVD) assay development. Roche joined HTG from Ventana Medical Systems/Roche Tissue Diagnostics, where he served as vice president of translational diagnostics and was responsible for interfacing with pharmaceutical partners in their development of targeted cancer therapeutics and facilitating the transition of biomarkers into companion diagnostics. He also led reagent product development at Ventana, launching more than 30 IVD products, including the FDA-approved c-Kit and HER2 tests.
“We are delighted to have Dr. Roche on board as he brings a wealth of senior scientific and leadership experience for IVD companion diagnostic assay development,” HTG’s Johnson said.