A local research collaboration has sparked the international sales launch of an advanced molecular test that could make its PrecisionPath Next Generation Sequencing (NGS) technology a “go-to” cancer test for community oncologists nationwide.
PrecisionPath is the direct result of collaboration with clinicians at the Greenville Health System Institute for Translational Oncology Research and Selah Genomics. Selah, now a nationally recognized molecular diagnostics company, was founded in 2006 to commercialize diagnostic technology licensed from Clemson University. Selah Genomics is the U.S. subsidiary of UK-based EKF Diagnostics.
“Early on, we realized there was a need for an accurate and affordable advanced molecular test for cancer patients specifically designed to support life-extending treatment decisions by community-based oncologists and pathologists,” said Michael Bolick, CEO of Selah Genomics. “This test and resulting report identifies a patient’s key genetic biomarkers and highlights potential targeted therapies for a patient based on that individual’s unique DNA fingerprint.”
“As the number of genes associated with these new therapies and clinical trials expands over time, PrecisionPath will continually evolve, providing clinicians with the latest information related to molecular-based therapies across many different cancer types,” said Bolick. “This is an important step towards personalized medicine – that is, harnessing genetics in a cost-effective manner to effectively target the right drug to the right patient.”
GHS has been using PrecisionPath to molecularly profile patient tumor tissue samples across an array of cancer types for more than a year now and was also involved in the early piloting phase of the product.
“We are excited by the opportunity to actively work with Selah to help standardize the availability of molecular medicine,” said Jeffery Edenfield, MD, the ITOR medical director. “The availability of this type of precise diagnostic testing is no longer confined to academic centers. PrecisionPath is an important step forward to assure that all patients can benefit equally and gain access to targeted treatments,” he said.
Since 2004, nationally recognized ITOR has been bringing pharmaceutical companies and biotech partners together with genomic researchers, cancer care providers and their patients.
PrecisionPath Colon, the first of multiple PrecisionPath products envisioned for the future, was selected for launch because oncologists treating advanced stage colon cancer patients have established guidelines on how to use the genetic information in the PrecisionPath report. This evidence of “clinical utility” is important in making the case for reimbursement of this leading-edge test by private insurers and Medicare.
“It’s not enough to have these extraordinary tests available in order to make a meaningful difference in a patient’s treatment decisions; patients have to be able to afford them,” said Edenfield.
The combination of reasonable cost and clear concise reporting, coupled with an unusually quick turn-around time of providing the results, will be a key market differentiator for the test. PrecisionPath Colon is priced at $975, helping to lead the way in setting affordable pricing necessary for broad adoption of genomic sequencing in cancer. Selah has also committed to a maximum 7-day analysis turnaround time, a fraction of the average time normally expected.
Clinicians in the community-based setting, who treat the overwhelming majority of cancer patients, would collect appropriate patient tumor samples and ship them to Selah. Selah would extract the DNA from the patient’s tumor tissue and then molecularly profile it at ITOR utilizing leading-edge Ion Torrent next-generation sequencing equipment. The results would be included in a report made available to the cancer patient’s oncologist via a web portal to Selah’s protected laboratory information system. Selah has plans for PrecisionPath Lung and PrecisionPath Breast, among other sites of cancer origin, as logical developments of this technology.
“Building on our recent announcement which utilizes and leverages PrecisionPath Colon in a four-way collaboration to create personalized medicine decision support tools with GHS and industry partners Becton Dickinson and DecisionQ, we see an immediate opportunity to advance clinical care in ways that were only hoped for within the last decade. Also, by working together in new and creative ways, we are actively establishing significant collaborations with like-minded institutions that are equally interested in contributing to large information databases that can lead to treatment breakthroughs,” said Bolick.
This partnership also represents an important first for GHS.
Greenville Health Research Development Corporation, GHS’ newly launched non-profit supporting entity focused on technology transfer and industry partnerships that can advance clinical care, has worked closely with Selah to commercialize PrecisionPath. GHS and Selah have already jointly invested more than $2.5 million, which includes both cash and in-kind contributions by both parties in know-how, time and resources, to create Selah’s Clinical Genomic Center at ITOR and pilot the new molecular diagnostic service.
“We are highly motivated by this unique opportunity to help launch a leading-edge diagnostic tool that can help improve outcomes for cancer patients in our region and beyond,” said Sam Konduros, the RDC’s executive director.
“For us, it’s a perfect business marriage. We’re helping develop and launch medical breakthroughs that can directly benefit patients, and any revenues that we receive will be exclusively utilized to strengthen our research and education efforts. While GHS has a history of working with technology companies to develop medical breakthroughs, this will be the first time that a partnering company will direct a portion of the revenues generated from sales to the RDC to provide financial support for GHS innovation strategies focused on enhancing patient care.”
“We celebrate this agreement as a first for the RDC as a designated innovation and economic development engine for GHS, which is one of the largest public health care systems in the Southeast,” said Konduros.
And while this unprecedented agreement is the first, it definitely won’t be the last, he promised.
Konduros sees the RDC as a critical player in the development of a bold vision and plan called “IMED” – which stands for Innovations in Medical Economic Development – to join GHS with private/public and local economic development partners to develop a chain of life science campuses in Greenville. The plan is still in the very early stages, but Konduros envisions the campuses as a magnet for biomedical and healthcare-related companies like Selah that will be a catalyst for high-paying, knowledge-based jobs.
“We’re a rising academic health center and the region’s largest public healthcare delivery system. We’re proud of the patient-centered work we do every day which will always be our primary focus. But, as vital as our healthcare mission is, we know it’s not enough. We’ve also got to do our part to strengthen the community’s economic health if we hope to fulfill the goal of helping to improve the health of our entire region.”
About EKF Diagnostics – www.ekfdiagnostics.com
EKF Diagnostics Holdings plc, which includes the EKF Diagnostics, EKF Molecular, Stanbio Laboratory, Separation Technology Inc., DiaSpect and Selah Genomics brands, specializes in the development, production and worldwide distribution of point-of-care blood analyzers for use in the detection and management of diabetes, anemia, lactate and kidney related diseases. Its new molecular division, EKF Molecular Diagnostics, focuses on technology used within the development of companion diagnostics, specifically within oncology. EKF products are sold in more than 100 countries around the globe, through a network of specialist distributors.
About Selah Genomics – www.selahgenomics.com
Greenville, SC, USA-based Selah Genomics is a clinical diagnostic specialist supporting healthcare providers and the pharmaceutical industry with advanced molecular and genomic diagnostic services. Selah’s services add value to early stage drug development, clinical trials and regulatory processes in the pharmaceutical industry and helps clinicians and healthcare providers treat and monitor patients, thereby improving patient outcomes. With the Power of Precision, Selah Genomics provides the best in molecular diagnostic testing, assay validation and genomic profiling that all leads to one common goal: to provide better outcomes for patients.
About Greenville Health System (GHS) – www.ghs.org
South Carolina’s largest healthcare system and the nation’s newest named academic health center is committed to advancing patient care through breakthroughs in healthcare delivery, access and affordability. To support these efforts, GHS launched the Greenville Health Research Development Corporation (RDC), a not-for-profit supporting entity, to further bolster the health system’s commitment to the communities it serves through technology transfer, business development, and economic development projects, such as IMED. IMED – Innovations in Medical Economic Development – is a visionary public-private initiative created to support and accelerate the development of a growing life sciences and healthcare industry cluster in South Carolina that will expand the regional economy and generate quality jobs. GHS and RDC provide strategic leadership and administrative support for IMED. The centerpiece of the vision will be the long-term establishment of the IMED corridor, to include a series of innovation campuses in Greenville County which will be home to biomedical and life sciences start-ups and established businesses in coming years.