NEW YORK (GenomeWeb) — UniConnect last week unveiled PrecisionMDx, a specialized version of its flagship UniFlow laboratory process management software for molecular testing laboratories.
In addition, UniConnect said that Exosome Diagnostics, a molecular diagnostics firm developing tests based on nucleic acids isolated from cellular microvesicles, and Selah Genomics, a company using next-generation sequencing and other molecular technologies for laboratory-developed testing and companion diagnostics, are early-access customers of Precision MDx.
UniConnect announced PrecisionMDx's launch at the American Association for Clinical Chemistry annual meeting in Chicago last week. At the conference, Clinton Maddox, director of implementations at UniConnect, told BioInform that the new version of his firm's LIMS is designed to "facilitate the translation of scientific innovation to diagnostics and therapies" and custom-built to support "the science and business of personalized medicine."
PrecisionMDx builds upon the company's web-based UniFlow platform. It uses a process specification language to manage laboratory processes involving multiple steps and information types such as samples, outputs, instruments, reagents, worker responsibilities, and requests.
According to Rick Mandahl, vice president of business development for UniConnect, the UniFlow platform is essentially designed "to support any aspect of discovery," and is compatible with any instrument, robot, database, or legacy system in life science research.
The platform is also extremely flexible, according to the company, and can be customized for specific projects or types of laboratories. However, with the explosion in molecular testing in recent years, and particularly the rise in laboratories developing and offering their own assays, UniConnect decided that a more focused version of its core platform could be beneficial.
The company developed Precision MDx, or PMDx, specifically to support CAP/CLIA-certified molecular laboratory operations. It can be deployed as standalone software or integrated with existing LIS/LIMS and billing infrastructure, and it can be installed locally or hosted in the cloud.
The platform supports entire laboratory workflows from sample entry to final report, and can scale up to support molecular diagnostics companies at the enterprise level. It can also be used to connect labs both regionally and globally, the company said.
Other features include support for molecular and companion diagnostic development and administration in oncology and infectious disease; customized workflows for each assay, with a specific eye toward PCR; and enhanced internal and external custom reports including production and secure PDF delivery with managed authentication.
The system also features comprehensive sample storage and archiving, personnel management, reimbursement functions enabling users to interface with multiple third-party billing system, and HIPAA-compliant patient management.
While UniConnect already had a sizeable number of customers using the UniFlow platform — including ARUP, Vivia Biotech, Dupont Pioneer, Sorenson Genomics, CompanionDx, and Transgenomic, to name a few — the company this week disclosed a pair of early adopters of the PMDx platform.
One of those clients, Selah Genomics (which was recently acquired by EKF Diagnostics), actually signed a license with UniConnect in September that enabled it to use a "purpose-built" version of UniFlow — essentially the PMDx platform, even though it had not yet been branded as such.
A second early adopter, Cambridge, Mass.-based Exosome Diagnostics is using the platform to manage its laboratory workflow as it works to develop molecular diagnostic assays that glean information from intact nucleic acids isolated from cellular exosomes and other microvesicles in the hopes of creating a "biofluid" approach to testing for diseases in which an invasive approach has previously been the only option.
Specifically, Exosome's first test will be a PCR assay panel to help distinguish between different prostate cancer types based on specific RNA signatures gleaned from exosomes. This assay is currently being validated in cooperation with the Prostate Cancer Foundation. Exosome also has an assay for lung cancer typing in the pipeline.
At AACC, William Tisel, director of project management at Exosome, told BioInform that his company chose to work with UniConnect because it needed a LIMS that was flexible, able to be deployed across multiple sites, widely applicable across sample types, featured both discovery and development modes, and excelled at reporting clinical results.
"We looked at several LIMS companies, and UniConnect stood out," Tisel said. He specifically lauded PMDx's sample accessioning, HIPAA-compliant patient reporting, and results delivery to physicians as being crucial to Exosome's business as it gears up to offer its molecular tests through a CLIA-certified laboratory.
"Many employees of UniConnect are former lab guys, so they speak the same language," Tisel noted, adding that the software is currently "being adopted nicely in our lab."
Tisel also said that UniConnect is currently rolling out the PMDx software for Exosome in modules. According to UniConnect, the platform can be implemented in standard eight-week chunks or at a pace required by the client.