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With Launch of Liaison Plex Platform, Diasorin Will Offer Flexible Test Pricing Plan


NEW YORK – When Diasorin launches its Liaison Plex platform for syndromic molecular testing in June, the company plans to charge users a price based on how many test results that they want.

If a laboratory runs, for example, Diasorin's 19-target Liaison Plex Respiratory Flex Assay, the instrument will perform the full molecular panel, but the lab can select an option to pay only a portion of the full panel price if it wants to see only seven results. The remaining 12 results would remain unreported unless the healthcare provider chooses to reveal one or more additional tiers of results and pay for those results using what Diasorin has dubbed Flex Credits.

Company officials declined to provide details on the pricing structure for the tiers of tests or the additional costs of Flex Credits, the balances of which will be loaded onto instruments through scanned barcodes. However, they said that labs will be able to choose whether to participate in the Flex program and, if they opt in, they can select from tiers how many results they want to see and choose which tests will be included in its reports.

Giulia Amicarelli, VP of global molecular marketing and marketing services for Diasorin's Luminex business, said that the Flex system lets healthcare providers adjust to needs depending on factors such as patients' ages, seasonal disease prevalence, and patient immunocompromised status. Angelo Rago, president of the Luminex business, added that Diasorin sees an obligation to deliver to doctors the information they need to inform patient care at the lowest cost.

"Plex is a piece of a long-term molecular strategy around diagnostic stewardship that ensures that the right test is being given to the right patient at the right time," he said.

Caroline Popper, cofounder and president of the healthcare and life sciences consulting firm Popper and Company, said that under such a flexible testing model, "Diasorin is making money on the basis of units of information generated, not on the basis of amounts of labor or reagents consumed."

Multichannel analyzers in general tend to generate more information than what clinicians request or need to guide patient care, and payors have been declining to reimburse for large panels that they deem necessary, she said. Using software to unlock tiers of results is a sensible response, allowing clinicians to adjust their panels as needed, and let healthcare providers submit claims for smaller numbers of targets while being able to buy additional results on-demand. If the lowest tier of testing is profitable, "everything else is gravy," Popper said.

In taking this step Diasorin is following at least one other diagnostic platform developer who is also offering tiered pricing for results from their instruments. QuidelOrtho has implemented a similar flexible testing program in its Savanna instrument which launched at the end of last year. That platform is used for qPCR-based multiplex panel testing with results for up to 12 targets in about 25 minutes, and company officials have said that the system's Test Select function lets users mask results on a multiplex panel and report only the targets requested by a clinician.

Diasorin's pricing strategy also follows US Food and Drug Administration 510(k) clearances last month for the Liaison Plex instrument and the Liaison Plex Respiratory Flex Assay, which includes 14 viral and five bacterial targets. Later in the month, the firm announced it had submitted its Liaison Plex Yeast Blood Culture Assay for 510(k) clearance and said that the panel was the first of three that the firm will use to aid the diagnosis of bloodstream infections on the Plex instrument. The firm has also been developing Gram-positive and Gram-negative blood culture panels and has announced plans to submit gastrointestinal assays for clearance in 2025.

The Liaison Plex uses nanoparticle chemistry technologies and allows labs to use direct DNA detection or PCR amplification.

According to Diasorin, the Liaison Plex has an operational hands-on time of two minutes per sample and a time-to-results of less than two hours.

While Rago declined to provide price figures for the tests, he said that if a lab runs Diasorin's full syndromic panels, the cost per panel will be comparable to the cost of PCR-based panels from its chief competitor, BioMérieux's BioFire. However, he said that with the flexible pricing option being offered with the Liaison Plex, it could cost less for a lab using Diasorin's system, depending on how many tests results the lab would want.

BioMérieux declined to comment for this article. The firm launched last year its BioFire SpotFire instrument for multiplex PCR testing within 20 minutes, and the firm said last month that it has greatly expanded over the past decade the installed base of its FilmArray syndromic testing platform.

BioMérieux officials previously said that they designed the SpotFire instrument to expand their reach into the outpatient and ambulatory care market and bring PCR-based syndromic testing closer to patients.

Meantime, the multiplex testing space is becoming increasingly crowded and competitive with other players including Qiagen, which recently launched its QiaStat-Dx Analzyer 2.0 for real-time PCR-based syndromic testing with results in about an hour, while Danaher subsidiary Cepheid just gained expanded its Xpert Xpress menu with a multiplex vaginal panel.

This week, Bosch and Randox Laboratories announced plans to invest €150 million ($162 million) into building out the PCR testing menu for Bosch's point-of-care Vivalytic platform, and Hologic has been developing new PCR-based panels for its Panther Fusion platform.

While the Liaison Plex uses the same nanoparticle chemistry technologies as Luminex's previous-generation Verigene PCR instrument, Amicarelli said that Diasorin has worked to simplify the workflow and reduce hands-on time in the Plex, which uses a single consumable cartridge that is stored at room temperature. Rago said that the Verigene instrument's assay kits, in contrast, included three components, one each to be kept frozen, refrigerated, and at room temperature. He also said that the Liaison Plex's cartridge design also incorporates a simplified method of adding samples to the cartridge for analysis.

Rago said that those changes will help laboratories address ongoing shortages of trained and capable healthcare staff. Diasorin will continue supporting the Verigene instrument and has no plans to discontinue it following the Liaison Plex launch, Amicarelli said.

The Liaison Plex is part of a slate of instruments that Diasorin has been developing for release in the next few years. In December, company officials said the firm was also moving forward with plans to apply in 2025 for marketing clearance of its Liaison XXL immunodiagnostic analyzer that delivers higher throughput and efficiency compared to its existing Liaison XL platform. The company is also finishing development of the Liaison MDx+ instrument that improves on the Liaison MDx analyzer through enhanced connectivity and software updates.

Another platform that Diasorin plans to launch in 2025 is the Liaison NES, a point-of-care molecular instrument for decentralized multiplex testing of up to six targets.

Amicarelli said that Diasorin has been preparing its sales force ahead of the Liaison Plex product launch and the firm is ramping up manufacturing. She said that Diasorin is focusing first on placing the Liaison Plex in the US and plans to later expand sales into Europe.

Rago said that in recent years Diasorin has invested heavily into automating operations at the Chicago facility where it produces the Liaison Plex assays. Before Luminex was acquired by Diasorin, Luminex had used the facility for a largely manual assembly process.

Rago said that the increased automation would let Diasorin adjust production to meet demand, fill orders without constraint, and continue to make a profit from test cartridges whether labs run the full panels or opt for the tiered model. Those investments have created a "diagnostic organization that we believe is really tooled up for the needs of not only our customers but also our shareholders," he said.