Clinical Genomics Announces Implementation of UNIConnect® Precision Molecular Diagnostics Laboratory Information Management System
Bridgewater, NJ and Salt Lake City, UT - Thursday, June 02, 2016
Clinical Genomics, a private company developing advanced diagnostic tools for colorectal cancer, today announced that it has signed an agreement with UNIConnect LC to implement the company’s Precision Molecular Diagnostics (pMDx™) laboratory information management system (LIMS) in its two laboratories. The software system will facilitate comprehensive automation of all laboratory processes from sample accessioning through final clinical result reporting.
Following an extensive evaluation period, Clinical Genomics selected pMDx based on the system’s fundamental focus on the needs and processes of the molecular diagnostics laboratory and the key quality and operational checks integrated in the LIMS software.
“As a rapidly expanding biotechnology company, we sought a laboratory software provider with proven expertise in the specialized molecular diagnostics space that would have the scale and flexibility to adapt to our needs over time,” said Lawrence LaPointe, Ph.D., President and CEO of Clinical Genomics. “We are confident that the pMDx platform will support our goals by enabling rapid specimen turnaround times, while ensuring high levels of accuracy and automation.”
Clinical Genomics plans to implement pMDx in its molecular diagnostics laboratories in Bridgewater, New Jersey and Sydney, Australia. Dr. LaPointe stated that, “As a growing global company, we value the ability of the pMDx platform to provide our labs with a consistent LIMS in the various markets where we currently operate and also where we anticipate future expansion.”
William S. Harten, UNIConnect Founder and CEO, noted, “Clinical Genomics’ blood-based colorectal cancer detection test has demonstrated strong potential to improve how the disease is currently monitored and managed. We are proud to announce our technology partnership and look forward to supporting their continued growth in the emerging liquid biopsy space. We’re particularly pleased that this relationship will introduce pMDx into the Australia/New Zealand market; 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.”
About Colorectal Cancer
Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths worldwide, accounting for more than 600,000 deaths each year. When diagnosed early, before cancer has spread, the relative five-year survival rate for CRC is 90 percent, but only about four out of 10 CRC cases are detected early. Among individuals undergoing surgical treatment for CRC, 30 to 40 percent of all cases recur, the majority of which present in the first two to three years following initial diagnosis and treatment. This early and concentrated pattern is relatively unusual among cancers, and offers the opportunity for structured surveillance to detect signs of recurrence.
One element of the standard of care for post-surgical monitoring for CRC recurrence, quarterly or semi-annual blood-based testing to measure carcinoembryonic antigen (CEA) levels, has poor sensitivity and specificity (statistical measures that indicate the definitive presence or absence of cancer). To address the need for more accurate oncology monitoring tools, Clinical Genomics has developed a new blood test to detect tumor-specific methylated DNA biomarkers that leak from active lesions into the circulatory system. Current data suggest that a genomic test specific for these biomarkers is more sensitive than CEA testing and highly specific.
About Clinical Genomics
Clinical Genomics is a privately held biotechnology company developing innovative products for colorectal cancer diagnosis. With a broad intellectual property portfolio consisting of more than 20 issued and pending patents, Clinical Genomics has developed a sensitive and specific blood test for colorectal cancer based on methylated DNA from two genes, BCAT1 and IKZF1, and plans to offer this 2-gene test for CRC recurrence monitoring in the U.S. beginning later in 2016. Clinical Genomics, via its wholly-owned subsidiary Enterix Inc., currently offers the user-friendly, patient-preferred colorectal cancer screening InSure® FIT™ assay, a fecal immunochemical test that detects blood in the stool. InSure is also marketed in Australia and other countries (as ColoVantage Home).
Clinical Genomics has offices and laboratories in Bridgewater and Edison, New Jersey and Sydney, Australia, and operates as an FDA-registered and TGA-licensed manufacturer and a NATA-accredited laboratory.
About UNIConnect LC
Based in Salt Lake City, UT, UNIConnect® LC has created a LIMS platform that marries breakthrough software technology with unparalleled customization and configuration control to advance the “omic” sciences and precision medicine. With a corporate ideal of “rigorous simplicity,” UNIConnect’s pMDx™ software solution enables complex process tracking, eliminating information management barriers that slow progress for many life science laboratories. For the exacting process detail required for precision medicine, molecular diagnostics, proteomics, clinical trials and more, pMDx delivers best-of-class solutions that empower successful laboratory operations. For more information, see www.uniconnect.com.