Fall 2013 - Innovation

Frontrunner Solutions in Genetic Testing Diagnostics

“As personalized medicine becomes a clinical reality, our goal is to provide accurate and relevant information for physicians to understand the scope and trajectory of the genetic testing industry and how it may impact their practices now and in the years ahead.”

— Mark Harris, PhD, CEO, NextGxDx

THE FIELD OF genetic testing has grown tremendously in the past three years. Fueled by a revolution in DNA sequencing and accelerated research in genetics and genomics, one to two new genetic testing products, it is estimated, are launched daily from molecular diagnostic laboratories across the industry. With information about specific tests scattered in many locations, inconsistent ordering processes and cumbersome results reporting, there is a rapidly growing need for tools that will help healthcare providers navigate this explosive field. Enter Mark Harris, PhD, founder and chief executive officer of NextGxDx.

NextGxDx is a healthcare information technology company that provides a web-based genetic diagnostics marketplace, allowing hospitals and physicians to quickly and efficiently identify appropriate genetic tests while cross-referencing multiple test providers. The company’s online portal curates information on the more than 10,000 genetic testing products currently offered by clinical laboratory improvement amendments (CLIA)-certified labs in the U.S. As a first-to-market platform, NextGxDx’s database is the most comprehensive catalogue of genetic testing products available to U.S. healthcare providers.

“Our research shows there are nearly 10 times more genetic tests available today than commonly thought, and yet there has not been a centralized, well-curated, user-friendly platform to help healthcare providers find and order the right test for a patient,” says Harris.

Innovation in the Online Marketplace

Harris was first introduced to the issues surrounding genetic testing diagnostics in 2010, when he was invited to join the leadership development program at Athena Diagnostics. Harris was tasked with spearheading a technology initiative, and it wasn’t long before he began to notice a significant lack of transparency in the industry surrounding genetic testing. Another issue he identified was the time-consuming test-ordering process, with the majority of tests ordered through a paper-based and extremely laborious process, requiring hours of research to identify the appropriate test and laboratory for the patient’s particular disease state. Once identified, it could take many more hours to complete the ordering process and wait for results. For Harris, the challenge presented an opportunity, and he began researching online marketplace concepts known for streamlining the selection process of goods and services and simplifying the end-user experience. From there, it was a matter of adapting and applying these concepts to the field of genetic testing.

“The goal was to simplify the ordering process for physicians and hospitals and improve ordering accuracy,” explains Harris. “From a lab’s perspective, this platform offers the opportunity to showcase the newest tests and attract new customers — it’s a win-win for all involved.”

With a solid idea in place, Harris joined forces with molecular geneticist Jud Schneider, PhD, along with a respected team of physicians, researchers, web designers and software engineers, and set out to create a web experience that would provide a one-stop shop for genetic testing. After developing a prototype, Harris and his team demonstrated the concept to more than 1,000 physicians, and after getting universally enthusiastic feedback, began presenting the idea to labs. Interest levels on both sides were high, and the NextGxDx platform was launched in October 2012.

“One of the features we developed to save physicians time was a program that links all the tests to specific disorders, and then categorizes them according to different medical specialties,” says Harris. “This allowed us to look at the data in new ways. For example, we had always heard that neurology was one of the most confusing fields when it came to genetic testing, so it’s not surprising that we found over 30 percent of the available tests are within that specialty area. Correspondingly, we’ve had a tremendous response from physicians in that field, especially pediatric neurologists.”

Harris says the platform offers an intuitive interface; within minutes, providers can easily identify the appropriate genetic tests for their patients, searching the database by gene or disorder —a process that previously could take up to two hours per test. The platform also allows side-by-side comparison of tests, and the company’s partnerships with laboratories across the country enable physicians to order tests directly from the secure and HIPAA-compliant NextGxDx website. “By offering the ability to research tests based on patient symptoms, instantly compare tests across laboratories and determine existing institutional relationships, we can provide physicians with a single destination for discovering, comparing and ordering genetic tests,” says Harris.

The NextGxDx management team, outside their offices in Franklin, Tenn. From left to right: Kevin McKnight, sales director; Dan Kauke, marketing director; Blake Blackshear, CTO; Mark Harris, PhD, CEO; Jud Schneider, PhD, scientific director; Julia Polk, acting CFO; Marshall Cottrell, developer; Jay Buford, SVP, business development.

Leading with Confidence

Harris has a broad range of experience in scientific research, data analytics, product design and technology commercialization. Armed with these skills and a fascination with the burgeoning field of genetics, he has confidently stepped into a role that places him at the forefront of a rapidly advancing industry. As the leader of a flagship company within a cutting-edge field, Harris describes his leadership style as both inspirational and motivational. “Our company was the first to develop a web-based genetic testing marketplace and the first to implement tools that compare genetic testing products across multiple laboratories. That places us in a leadership position, and our long-range goal is to continue to innovate systems and methods that help patients get the appropriate test the first time,” he states.

In late 2012, NextGxDx explored the factors informing and shaping the genetic testing industry in the white paper The Genetic Testing Landscape: Finding the Needle in the Haystack. According to Harris, the paper provides an overview of the genetic testing industry, including the size of the industry, how genetic tests are used and how genetic information is communicated. It also outlines key strategies for the future of clinical integration of genetic testing and personalized medicine. The paper, authored by Schneider, NextGxDx’s scientific director, establishes a robust analysis of genetic testing as it relates to the products currently available for clinical use. “As personalized medicine becomes a clinical reality, our goal is to provide accurate and relevant information for physicians to understand the scope and trajectory of the genetic testing industry and how it may impact their practices now and in the years ahead,” says Harris.

While Harris’ company is still in its first year of growth and expansion since its marketplace was launched, the ambitious entrepreneur already has his sights on future innovations: “Helping patients and their families diagnose their genetic disorders the first time — that’s what drives us,” says Harris. “The way we execute that mission is by becoming a one-stop shop for all genetic testing needs. Our technology is designed to eliminate the workflow and information barriers that hinder the genetic test ordering process. For example, as we look at patient out-of-pocket costs, we’re researching ways of incorporating insurance eligibility tools into our online services that would provide guidance to the patient on how much the ordered test will cost them after insurance has paid. Our plan is to develop partnerships with other industry leaders to better link services like these through our single, consolidated platform.”

Trudie Mitschang
Trudie Mitschang is a contributing writer for BioSupply Trends Quarterly magazine.