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Clinical Genomics Using UniConnect LIMS to Support CRC Recurrence Test Commercialization


NEW YORK (GenomeWeb) – Clinical Genomics, a privately held company developing a blood-based molecular diagnostic test for colorectal cancer recurrence, said today that it will implement UniConnect's molecular diagnostics-specific laboratory information management system in its two laboratories in the US and Australia.

The deal provides Clinical Genomics with a "cornerstone piece" as it readies its assay for commercialization in the US later this year and in Australia soon thereafter, Laurie Huard, vice president of laboratory operations for Clinical Genomics, told GenomeWeb.

Meantime, for UniConnect, the arrangement increases the breadth of applications and expands the geographical reach for its LIMS, called Precision Molecular Diagnostics (pMDx).

With laboratories in Bridgewater, NJ, and Sydney, Clinical Genomics is developing a test that detects two tumor-specific methylated DNA biomarkers — BCAT1 and IKZF1 — in patient blood samples for post-surgical monitoring of CRC recurrence.

In January, the company presented new data at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium demonstrating that its test is three times more effective at detecting recurrence than measuring carcinoembryonic antigen levels.

In March, Clinical Genomics closed a $15 million Series A financing round to help it commercialize the assay. At the time, the company said it hoped to launch the test in the US later this year followed by Australia and European countries that recognize the CE mark.

This week, the company reiterated its US commercialization timeline, indicating that it would first commercialize the assay through a laboratory-developed pathway, but it may seek US Food and Drug Administration clearance in the future.

Huard told GenomeWeb that selecting UniConnect's LIMS, which will be implemented in its labs later this month, is a crucial step toward its commercialization goals.

"You have to have the people, you have to have the equipment, and you have to have the delivery mechanism to the physician so he can act on the result," Huard said. "In order to make all those pieces work, this particular software is a requirement, basically. LIMS absolutely … creates a much safer and secure environment to do [complex lab] testing and get an accurate result. That is a cornerstone piece of a properly managed lab where people can count on the result."

Huard noted that Clinical Genomics evaluated several LIMS, eventually whittling it down to UniConnect's pMDx and two other software solutions from unnamed competitors. In the end, UniConnect's molecular diagnostic-specific architecture won the day.

"This particular software compared to other offerings, including from some [larger companies], actually specializes in molecular diagnostic workflows … [which] is very complex compared to other laboratory disciplines," Huard said. "One thing that we're able to do with [UniConnect's] product that was either very difficult to configure or just not available in other offerings has to do with how critical traceability is for reagents and the preparation of those reagents for clinical testing."

Huard said that without these features, the company's lab would be forced to do a lot of manual document recording, which greatly increases the chance for error.

The pMDx software also has "a tremendous specimen-tracking capability that can take a single sample that may be split into two or three parts and keep up with all of them throughout the workflow up until the patient report," she said.

Finally, UniConnect already has experience deploying its LIMS outside the US, and although Australia will be a new continent for the company, "we weren't really taking a risk because they've already [successfully] deployed it outside the US," Huard said.

UniConnect, based in Salt Lake City, has been in the LIMS business for nearly two decades, but launched the pMDx product in 2014, building upon its flagship UniFlow platform, which 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.

Early-access customers for pMDx included Exosome Diagnostics, which develops tests based on nucleic acids isolated from cellular microvesicles, and Selah Genomics, which uses next-generation sequencing and other molecular technologies for laboratory-developed testing and companion diagnostics.

Later in 2014, UniConnect landed Children's Hospital Colorado's molecular diagnostics laboratory as a customer, which is using the system to coordinate a number of molecular testing methods including next-generation sequencing.

And earlier this year, Tute Genomics partnered with UniConnect to support NGS-based newborn screening panels being developed by Newborn Screening Ontario, a molecular testing laboratory at the Children's Hospital of Eastern Ontario.

Clinical Genomics' CRC recurrence test currently uses unspecified PCR technology to detect the presence of the two hypermethylated genes, but the company has noted that sequencing could also be used. The pMDx LIMS is expected to work equally well whichever method is eventually used, and in fact helps demonstrate the cross-application utility of its software, the company said.

Clinical Genomics' test "has demonstrated strong potential to improve how the disease is currently monitored and managed," William Harten, UniConnect Founder and CEO William Harten said in a statement.

"We're particularly pleased that this relationship will introduce pMDx into the Australia/New Zealand market," Harten added. "UniConnect systems are already utilized in North America, with deployments in Europe, Asia, and Africa. Our relationship with Clinical Genomics will provide local exposure to a robust and growing life sciences community."