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DiaSorin Aims to Deliver Slate of Updated Instruments, New Assays in 2024, 2025

NEW YORK – DiaSorin executives on Friday said they're planning to bolster the company's position in immunodiagnostics and molecular testing over the next two years with a series of updated instruments and an expanded testing lineup for use in labs and at the point of care.

Speaking on the firm's 2023 Investor Day conference call, DiaSorin Chief Commercial Officer Chen Even said the Saluggia, Italy-based firm is moving forward with plans to launch its Liaison XXL immunodiagnostic analyzer, which is designed for higher throughput and efficiency than the existing Liaison XL platform and will be used to take advantage of the trend of laboratory consolidation. The XXL instrument uses the same cartridges as other Liaison instruments, and the firm said it plans to gradually convert the existing XL installed base to the XXL instrument.

The company plans to apply for US Food and Drug Administration marketing clearance for the instrument in 2025.

Even noted that the firm partnered with Qiagen for development of the Liaison QuantiFeron-TB assay for latent tuberculosis and said the companies have continued collaborating toward an immunoassay for early detection of Lyme disease on DiaSorin's Liaison instruments with an expected submission this month of the Lyme assay for FDA clearance. The firm is also developing a third-generation Liaison Calprotectin immunoassay to aid diagnosis of inflammatory bowel diseases and reduce unnecessary colonoscopies with expected submission to the FDA in 2025. The firm plans to continue expanding its menu of specialty assays for pathogens such as Legionella and Streptococcus species.

Angelo Rago, president of DiaSorin's Luminex subsidiary, said the firm is also preparing to soon launch its Liaison MDx+ instrument, which he said improves on the Liaison MDx analyzer with enhanced connectivity and software updates. The firm is planning to migrate the full MDx menu onto the MDx+, including the eight-well direct amplification discs for use in moderate-complexity labs and 96-well discs for use in high-volume labs. It also will include specialty products highly desired by some customers such as tests for congenital cytomegalovirus infections in newborns, herpes simplex viruses types 1 and 2, and varicella-zoster virus.

"As part of this transition, we're going to discontinue the Luminex Aries product because of the given overlap in positioning and menu," he said. "The Liaison MDx+ will be finalized in 2024, and we will start submitting to the FDA in waves the stages of different panels on the MDx to bring them onto the MDx+ over 2024 and 2025."

The firm is also preparing to launch its Liaison Plex multiplex molecular testing instrument, which will replace its Verigene system with an instrument that offers flexible testing menus that can be tailored to each patient rather than all-in-one tests. Rago said that option can reduce testing redundancy and cost, and the Plex can also help address workforce shortages through its simplified workflow, room-temperature reagent storage, and low hands-on time.

The company expects FDA clearance for the instrument and a multiplex respiratory panel in early 2024. The company plans to submit for clearance on the instrument blood-based assays for Gram-positive, Gram-negative, and yeast detection in 2024 as well as gastrointestinal assays in 2025.

Finally, the company is also planning to launch in 2025 its portable Liaison NES instrument for decentralized multiplex testing with up to six targets. Physicians can receive patient-side results in "minutes instead of days" with confidence in the results, Rago said.

"We're going to submit the product for differential diagnosis of Flu A, Flu B, RSV, and COVID-19 in Q2 of 2025, after the flu season of 2024 and '25, and Group A strep in Q3 of 2025," he added.

DiaSorin CEO Carlo Rosa said the firm has evolved from a focus on immunoassays through its expansion in recent years into molecular diagnostics and its $1.8 billion acquisition of Luminex in 2021. Since the acquisition, 60 percent of DiaSorin's employees are American and 50 percent of its revenues come from the US.

"We have a slew of products and systems that do fit the US market, and we are investing in the US market to continue to make it stronger and bigger, as we have done in the last three years," he said.

DiaSorin CFO Piergiorgio Pedron said on the call that sales in North America are projected to account for 55 percent of DiaSorin's sales by 2027, up from 30 percent in 2019, whereas its sales in Europe are expected to decline to 30 percent by 2027 from 45 percent in 2019. He said that shift is consistent with the strategy undertaken with the Luminex acquisition, which let the company grow its market share in the US, "the biggest IVD market in the world and the only one that really rewards innovation."

Rosa said DiaSorin's pre-COVID-19 decision to move some manufacturing to China by 2027 will make the company compliant with guidelines issued by China's government in 2021 related to local manufacturing requirements. DiaSorin plans to focus its efforts in China on growing specialized products related to gastrointestinal health and tuberculosis, and the firm expects to launch its Liaison XL instrument in China by 2025.