Letter to Shareholders
I am honored to have to opportunity to comment on the year just ended of DiaSorin, a company which is constantly evolving and which I am very proud of.
This pride is, above all, a consequence of the strategic choices that are the prerequisite for a solid and sustainable growth driving our Group towards new and important objectives we have set for the years to come.
The objectives we are pursuing in all our testing technologies make us an ambitious company that is constantly oriented towards innovation, growth, dedication in providing concrete answers not only to laboratories, but also to clinicians and patients. A company which is aware of its role in innovation and of its ability to rapidly develop high-quality diagnostic solutions.
With the end of the pandemic’s acute phase, during which the priority for laboratories was to handle high test volumes for the diagnosis of COVID-19, in 2022 diagnostic tests have been brought back to pre-pandemic levels.
We resumed the LIAISON® XS rollout, a platform designed for hospital laboratories, both public and private, and commercial laboratories by leveraging the features that make it the most suitable platform for laboratories with low and medium specialty test volumes.
LIAISON® XS is also the best solution for diagnostic facilities distributed across the territory: routine testing is performed in a centralized reference "hub", which offers high-throughput processing in a very short time, while specialty testing, for which greater proximity to the patient is deemed necessary, is performed in smaller decentralized diagnostic facilities.
The VERIGENE® platform is scalable, allowing throughput customization to meet the size and testing demands of each laboratory. From a single biological sample can rapidly and accurately detect a wide range of infectious pathogens and their associated drug resistance markers.
Panels available on the platform are designed to target infections in the bloodstream, respiratory tract, and gastrointestinal tract.
In 2022, we successfully continued to launch our state-of-the-art xMAP® INTELLIFLEX® platform, developed primarily for the scientific research market. We consider this product as a major growth driver of our Licensed Technologies offer.
The xMAP® INTELLIFLEX® is the modern, compact and robust version of the xMAP® platform, which has been developed by Luminex and is considered the industry’s gold standard for multiplexing of biological tests. The platform enables user to acquire data on two parameters per target nucleic acid or protein, saving time and generating more data with fewer samples.
Product & Business development
LIAISON® Memed bv®
FDA 510 (k) clearance of the LIAISON ® MeMed BV ® test, developed following the licensing agreement signed with MeMed. The test is the first high throughput blood test to differentiate between viral and bacterial infections.
38 tests on the LIAISON®XS platform
Validation of 38 tests on the LIAISON ® XS platform, bringing the total amount to 86 tests and thus making its menu increasingly relevant for small and medium- sized laboratories.
Partnership with B·R·A·H·M·S
Signing of a partnership with B·R·A·H·M·S, part of Thermo Fisher Scientific, for the development and commercialization of the LIAISON ® B·R·A·H·M·S MR-proADM™, an immunodiagnostic test offering a more precise assessment of disease severity and improving patient management.
Simplexa™ SARS-CoV-2 Variants Direct ASSAY
New Simplexa™ SARS-CoV-2 Variants Direct Assay (Research Use Only) for the detection of mutations associated with the new COVID Omicron variant.
ARIES® Flu A/B & RSV+SARS-CoV-2 ASSAY
CE Marking of ARIES ® Flu A/B & RSV+SARS-CoV-2 Assay for the detection of the 4 most common respiratory viruses and their underlying respiratory infections.
Simplexa™ COVID-19 Direct
FDA 510(k) clearance of Simplexa™ COVID-19 Direct test for the detection of SARS-CoV-2 from nasal or nasopharyngeal swabs.
Analyte Specific Reagent (ASR)
Launch of Analyte Specific Reagent (ASR) primer pair to detect the B17R/B18R gene of monkeypox virus, responsible for the health emergency declared by the World Health Organization.
Simplexa™ Congenital CMV Direct
FDA 510(k) clearance of the Simplexa™ Congenital CMV Direct test for the direct detection of Cytomegalovirus DNA in both saliva swab and urine specimens from babies 21 days old or younger.
LIAISON ® NES
Extension of collaboration with BARDA (Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services) to support the FDA 510(k) clearance of the LIAISON ® NES.
xMAP® NxTAG® GPP
CE marking of the xMAP ® NxTAG ® GPP Gastrointestinal molecular panel to detect nucleic acids from 16 of the most clinically relevant bacterial, viral, and parasitic pathogens in stool samples on the MAGPIX ® platform.
Simplexa™ COVID-19 & Flu A/B Direct
FDA 510(K) clearance of the Simplexa™ COVID-19 Flu A/B assay to detect Flu A, Flu B, and SARS- CoV-2 viruses in about an hour
sale of the assets related to the Flow Cytometry & Imaging (FCI) business unit
Sale, in February 2023, of the assets related to the Flow Cytometry & Imaging business unit to Cytek ® Biosciences.