Automated Multiplexing Molecular Diagnostic Platform Revolutionizes Infectious Disease Diagnostics

A new fully automated multiplexing molecular diagnostic platform offers an innovative and cost-effective testing approach by allowing customization of tests along with the ability to process and pay for desired results, thus enabling laboratories to maximize testing efficiencies.

Diasorin’s (Saluggia, Italy) new LIAISON PLEX platform provides complete flexibility for the customization of syndromic panels and helps overcome the challenge of the “one size fits all" approach faced by clinical laboratory staff for infectious disease syndromic diagnostics. Custom panels enable adjustments in response to seasonal changes and updates in clinical guidelines, helping prevent unnecessary and costly over-testing - a common issue with fixed, broad syndromic panels currently in use. The user-friendly, fully automated sample-to-answer system offers a streamlined workflow and room-temperature stable consumables, simplifying storage and transport logistics. Additionally, it requires just two minutes of hands-on time per sample and can deliver results in less than two hours.

Image: The LIAISON PLEX system has received US FDA 510(K) clearance (Photo courtesy of Diasorin)

The LIAISON PLEX, originally named VERIGENE II by Luminex, is VERIGENE’s successor, which is already providing flexible solutions with its Respiratory Panel. The PLEX system takes the Flex Testing concept to a new level with full customization of its existing and upcoming panels and full automation. This minimizes sample preparation time and contamination risks for laboratory technicians. The improved flexibility and automation add value for patients, clinicians, and payers. Given its unique features and technology, LIAISON PLEX is expected to boost Diasorin's commercial strategy in the U.S. by focusing on the hospital segment, leveraging IDNs, teaching institutions, and medical centers.

The LIAISON PLEX Respiratory Flex Assay is capable of testing for 19 pathogens linked to respiratory infections, which include 14 viral and 5 bacterial targets from nasopharyngeal swabs. The platform's Flex testing technology is unique in that it allows laboratories to select and pay for only specific results based on the patient's clinical symptoms, as opposed to standard panel tests that process all results simultaneously. This Flex approach enhances clinical utility and can lead to better reimbursement rates, making it a more cost-effective option for patients. The application of such targeted panel testing aids in precise diagnosis and treatment, aligning with the goals of diagnostic stewardship. This leads to reduced unnecessary patient therapies and avoids the costs associated with over-testing. The LIAISON PLEX platform, along with its Respiratory Flex Assay, has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA).

“The LIAISON PLEX and its Respiratory Panel will allow clinical laboratories and physicians to tailor tests to the needs of their patient population,” said Angelo Rago, President of Luminex. “The LIAISON PLEX is truly a laboratory's sample-to-customizable answer solution and we believe this will help address the growing demand for diagnostic stewardship, fiscal responsibility, and operational efficiency in clinical labs and healthcare systems throughout the U.S.”

“The clearance of the LIAISON PLEX along with its first panel marks a significant and strategic milestone for Diasorin after the Luminex acquisition, delivering to the market an innovative platform that is uniquely positioned in the growing multiplexing industry” added Carlo Rosa, CEO of Diasorin. “The flex technology exemplifies our forward-looking approach to diagnostic development, tackling the current limitations of the multiplexing market with a fully automated and customizable panel, and providing customers with the needed flexibility to adopt this technology in a cost-effective manner.”