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DiaSorin

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DiaSorin S.p.A. is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics and since July 2021, it is also active in the Life Science business. The group was founded in 2000 and is headquartered in Saluggia, Italy. Its production is at several plants located in Europe and the United States: Saluggia and Gerenzano (Italy), Dietzenbach (Germany), Stillwater, Minnesota (US), Dartford (UK). Following the acquisition of Luminex, the company acquired five additional production plants located in the United States (Austin, Madison, Chicago, and Seattle) and in Canada (Toronto). The company is a constituent of the FTSE MIB index.

DiaSorin S.p.A.
Company typePublic
BIT: DIA
IndustryBiotechnology
Founded2000; 24 years ago (2000)
Headquarters
Saluggia
,
Italy
Key people
Gustavo Denegri (chairman)
Carlo Rosa (CEO)
ProductsIn vitro diagnostics instruments and services
Websitediasoringroup.com

The Group is mainly active in the development, production and marketing of diagnostic tests used by the medical community to assess a patient's values, understand their state of health or monitor the progression of a disease.

DiaSorin offers diagnostic assays employing two of the most common technologies in in vitro diagnostics: immunodiagnostics and molecular diagnostics. Both technologies are based on automated technological platforms developed by DiaSorin in collaboration with partner companies on specifications provided by DiaSorin.[1]

DiaSorin's "core business" is the design and development of diagnostic test kits (reagents) that run on such platforms.

DiaSorin also focuses on the development of research and laboratory kits in the field of molecular diagnostics, particularly specializing in the infectious diseases sector with tests that use different matrices including blood, cerebrospinal fluid, cutaneous and mucus swabs.[2][3]

Activities

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DiaSorin focuses its efforts on several fields of immunodiagnostics: infectious diseases, bone and mineral, endocrinology, hypertension, oncology, gastrointestinal infections, autoimmunity and brain and cardiac markers.

The company is also active in molecular diagnostics for infectious diseases and for the detection of some forms of leukemia.[4]

In 2021 DiaSorin also entered into the Life Science space, through the acquisition of Luminex Corporation, gaining access to its Multi-Analyte Profiling (xMAP) technology and to its Flow Cytometry business

DiaSorin develops, manufactures and markets tests for the diagnosis of infectious diseases or hormonal disorders. The immunodiagnostic and molecular tests are aimed at both private and hospital analysis laboratories worldwide.

In immunodiagnostics, DiaSorin offers the market proprietary-based platforms on the CLIA[5] and ELISA[6] technologies.

In molecular diagnostics, DiaSorin offers proprietary platforms that cover the three phases of the testing process: extraction, amplification and detection.[7]

History

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The origins of the company date back to 1968, when near on an initiative of Fiat and Montecatini, the "Sorin Biomedica" was founded by the "Società Ricerche Impianti Nucleari - Sorin".[8] In 1997 American Standard acquired Sorin Biomedica, together with Immunonuclear Corporation (Incstar, Inc.). The two companies formed the Medical System Group of American Standard that later on came to include also Sienna Biotech, Inc[9] DiaSorin became an independent Italian group in 2000, through a management buyout operation led by Carlo Rosa and Gustavo Denegri.[10]

The etymology of the name contains the acronym of Sorin, "Nuclear plant research company", the company established in the 1960s, and "Dia" which stands for Diagnostics. In 1997 Sorin decided to build upon the activities relating to in vitro diagnostics into a company that took on the name of DiaSorin Vercelli.[11]

Acquisitions and partnerships

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In 2002 DiaSorin acquired BYC Sangtec and the rights to the Liaison platform. The commercial expansion led to the opening of new branches in Mexico, Israel, and China. The Liaison portfolio was enriched with products for new and clinical specialty areas. In the same year, tests previously developed with ELISA technology were converted to the most recent and automated CLIA.[8]

On July 19, 2007, the DiaSorin title debuted at Borsa Italiana Stock Exchange.[12]

In 2014 the company obtained the approval of hepatitis and retrovirus tests in China; in the same year, DiaSorin launched new tests to detect leukemias. DiaSorin Group signed an agreement in 2015 with Beckman Coulter for the commercialization in China of DiaSorin hepatitis and HIV tests.[13] In 2016, DiaSorin and Beckman Coulter signed an additional partnership, with the aim to provide customers in the U.S. the same hepatitis and HIV tests. The two companies are working together to submit the products to the Food and Drug administration (FDA) for approval and commercialization in the U.S.[14] In this year, the group acquired of Focus Diagnostics’ business unit, enabling it to expand its activities in molecular diagnostics.[15][16]

In 2017, a partnership with Qiagen offered an automated solution for detection of tuberculosis with QuantiFERON-TB Gold Plus available on the Liaison analyzers. That was also the year of the Siemens Healthineers ELISA business acquisition.[17]

In October 2018 the Saluggia branch began a partnership with Meridian for the distribution of a Helicobacter pylori detection test in the United States and United Kingdom. The companies have put in place a framework under which they may work together on the development of new tests and products.[18]

In 2019 the commercial launch of Liaison XS approval of latent tuberculosis test in the United States.[19]

In 2020 DiaSorin signed an exclusive license agreement with TTP for the automation of molecular diagnostic tests on a Point-of-Care platform.[20]

In September 2020 DiaSorin and MeMed started a strategic partnership for the development and commercialization of a diagnostic solution based on the patients' immune response that can differentiate between bacterial and viral infections.[21]

In April 2021, in partnership with QIAGEN, DiaSorin launched in countries accepting the CE Mark the LIAISON LymeDetect test for the early diagnosis of Lyme Borreliosis, based on the QuantiFERON technology.

On 14 July 2021 DiaSorin announced the completion of the acquisition of Luminex Corporation.[22][23][24]

Recent developments

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Diasorin's response to the Covid-19 pandemic

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On 7 April 2020, DiaSorin announced the development of a new IgG CLIA test to identify antibodies against SARS-CoV-2 antibody, test that allows to detect antibodies directed against the virus in patients’ serum samples, identifying subjects who have developed an immune response to the virus, offering a tool for epidemiologic assessment of populations.[25]

On 25 April 2020, DiaSorin received Emergency Use Authorization from the U.S. Food and Drug Administration for a new serologic test for COVID-19.[26]

On May 2, 2020, DiaSorin received approval for the commercialization of the LIAISON SARS-CoV-2 S1 / S2 IgG test in Brazil from ANVISA, the Brazilian health regulatory agency, and on May 12, 2020, the same test obtained approval from Health Canada, the Canadian government department responsible for federal health policy. This latter officially issued approval made the DiaSorin serological test the first to receive authorization in the country.[27][28]

On June 30, DiaSorin announced the launch of the new LIAISON SARS-CoV-2 IgM test, CE marked and made available in the United States through the validation notification submitted to the Food and Drug Administration (FDA), which was followed by the authorization request for emergency use, as required by the "Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)". DiaSorin announced it obtained the Emergency Use Authorization by the FDA on October 1, 2020.[29][30]

On September 7, 2020,  DiaSorin announced that it has received FDA Clearance for its Simplexa™ Flu A/B & RSV Direct Gen II kit. The molecular assay can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARS-CoV-2, influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV).[31]

On September 16, 2020, DiaSorin attained CE Marking for the addition of saliva specimens for use with the Simplexa™ COVID-19 Direct assay.[32][33]

On October 1, 2020,  DiaSorin received U.S. FDA Emergency Use Authorization (EUA) for its LIAISON SARS-CoV-2 IgM test. The LIAISON SARS-CoV-2 IgM test will be available on the LIAISON XL platforms installed in the U.S. market, using chemiluminescence immunoassay (CLIA) technology for the qualitative determination of specific IgM antibodies to SARS-CoV-2 in human serum or plasma samples. The test identifies the presence of IgM antibodies in patients who have been infected with SARS-CoV-2, enabling the distinction between newly infected and past-infected patients.[34][35]

On October 26, Diasorin announced the obtainment of the CE mark for the launch of the new Liaison Sars-Cov-2 Ag antigen test, capable of detecting COVID-19 on symptomatic patients and determining their viral load.[36] The test received U.S. FDA Emergency Use Authorization (EUA) on March 29, 2020.[37]

On January 11, 2021, DiaSorin launched in countries accepting the CE Mark the LIAISON SARS-CoV-2 TrimericS IgG test. The test was developed using the full length SARS-CoV-2 Spike protein in its Trimeric form, which perfectly mimics the native conformation of the protein. The test is therefore able to detect the full variety of the natural immune response to the virus reducing the risk of false negative results. The test, originally available in countries accepting the CE Mark, received U.S. FDA Emergency Use Authorization (EUA) on May 20, 2021.

On April 6, 2021, DiaSorin launched in countries accepting CE Mark a new Point-of-Care immunodiagnostic platform, the LIAISON IQ, developed in partnership with Lumos Diagnostics together with a first test to detect antibodies against SARS-CoV-2. On May 25, 2021, an additional test was made available on the LIAISON IQ platform, to detect the COVID-19 antigen in nasal and nasopharyngeal swabs. Both tests use lateral flow technology.

On May 21, 2021, DiaSorin launched a molecular diagnostic test to easily detect the mutations associated with the most common variants of SARS-CoV-2.[38]

Technologies

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The research team of about 200 people is dedicated to the development of solutions for specialized tests to support doctors and laboratory managers in the processing of diagnoses of even niche diseases. The technologies of immunodiagnostics and molecular diagnostics applied to the tests of DiaSorin are based on automated technological platforms developed by partner companies based on specifications indicated by DiaSorin. Such platforms are open to interconnection with the ones of other diagnostic operators.[39]

Analysis kits

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DiaSorin tests are biochemical components that aim to determine the presence of a specific element (virus, hormone, etc.) in the sample taken from the patient. The two technologies used, immunodiagnostic and molecular diagnostic, identify the presence of the component sought—even in minimal quantities, to define its characteristics.

The areas of DiaSorin's offer for analysis kits in the specialty immunodiagnostics sector are the following:

• Infectious diseases

• Gastrointestinal infections

• Bone and mineral metabolism

• Endocrinology

• Hypertension

• Oncology

• Onco-hematology

• Autoimmunity

In particular, in the field of molecular diagnostics, DiaSorin has focused its research on the area of infectious diseases, with tests based on different matrices—including blood, cerebrospinal fluid, skin, and mucocutaneous swabs.[40]

Immunodiagnostics Platforms

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LIAISON XL

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The LIAISON XL is the highly automated analyzer on which is integrated the menu of specialty diagnostic tests offered by the Group. The platform can be used both in stand-alone configuration and through the connection of the instrument to the Laboratory Automation Systems of the leading players on the market.

LIAISON XS

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The LIAISON XS analyzer, currently available in European countries, is designed for analysis laboratories with low-medium throughput needs that can take advantage of this new platform for specific needs related to specialty tests.[41]

Geographical Presence

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In 2019 DiaSorin generated revenues (706.3 million euros) in Europe and Africa for 46.1%, in the United States and Canada for 29.1%, in Asia and Oceania for 19.0%, in America Latin for 6.3%. Sales concern CLIA tests for 65.7% (122 fully automated tests relating to infectious diseases, hepatitis and retroviruses, gastrointestinal infections, cardiac markers, bone metabolism, and endocrinological tests), for 14.2% ELISA tests (partially automated), for 8.5% molecular diagnostic tests, for 11.6% diagnostic equipment. The production plants are located in Saluggia and Gerenzano in Italy, Dietzenbach in Germany, Stillwater, Cypress in the US, and Dartford in the UK.

The marketing of the Group's products in the European, US, Mexican, Brazilian, Chinese, Australian, and Israeli markets is mainly managed by the commercial companies belonging to the DiaSorin Group. In countries where the Group does not have a direct presence, an international network of over 200 independent distributors exists.[42]

Partnerships and Collaborations

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Over time, DiaSorin has entered into partnerships to develop joint business lines. These include partnerships with Qiagen, for the development of an automated solution for the diagnosis of latent tuberculosis[43] and with Beckman Coulter, for the registration in the Chinese and US market of automated tests for the analysis of hepatitis and retroviruses.[44][45]

Shareholder base

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Shareholder (2021 [1][46]) Share %
Finde SS 43,95%
Rosa Carlo 0,08%
Even Chen Menachem 0,08%
T. Rowe Price Associates, Inc. 3,03%
Market 39,43%

Financial data

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DiaSorin has been listed on the Italian Stock Exchange since 2007 and is in the FTSE Italy Mid Cap Index.

(in million Euros)[4] 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Sales and service revenues 206,3 244,6 304,1 404,5 440 433,7 434,8 443,7 449,1 569,3 637,4 669,2 706,3 881,3
Cost of sales (73,8) (84) (90,4) (119,8) (126,1) (136,4) (135,1) (145) (157,2) (180,1) (205,5) (214,4) (217,6) (278,4)
Gross profit 132,5 160,6 213,6 284,7 313,8 297,3 299,6 298,7 341,8 389,1 431,9 455,8 488,7 602,9
EBIT 47,5 70,7 106,4 145,5 163,3 140,2 134,6 129,8 152 172,6 184,4 204,5 217,9 324,2
Profit before taxes 44,1 59,8 103,7 144,9 158,2 137,4 129,3 128,1 150,1 168,1 178,7 204,4 216,3 321,4
Net result 26,3 37,4 70 90,4 99,6 87,6 83,1 84 100,5 112,6 139,8 158,1 175,7 248,3
EBITDA 61,5 85,6 123,6 167,1 190 169,5 163 160,2 184,9 217,3 237,9 255,4 276,8 385,3

Management

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Role Name
Chairman Gustavo Denegri
Chief Executive Officer Carlo Rosa
Chief Commercial Officer Chen Even
Senior Corporate VP e Chief Financial Officer Piergiorgio Pedron
Senior Corporate VP Human Resources Stefano Ronchi
Senior Corporate VP Industrial Operations Ugo Gay

Notes

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  1. ^ "Liaison".
  2. ^ "Diasorin Annual Financial Statements at 12.31.2019" (PDF). Archived (PDF) from the original on 2021-03-07.
  3. ^ "Company Profile" (PDF).
  4. ^ a b "Annual Financial Report at December 31, 2017". 27 June 2018. Retrieved 30 January 2019.
  5. ^ Cinquanta, Luigi; Fontana, Desré Ethel; Bizzaro, Nicola (2017-06-24). "Chemiluminescent immunoassay technology: what does it change in autoantibody detection?". Auto-Immunity Highlights. 8 (1): 9. doi:10.1007/s13317-017-0097-2. ISSN 2038-0305. PMC 5483212. PMID 28647912.
  6. ^ Engvall, Eva; Perlmann, Peter (1972-07-01). "Enzyme-Linked Immunosorbent Assay, Elisa: III. Quantitation of Specific Antibodies by Enzyme-Labeled Anti-Immunoglobulin in Antigen-Coated Tubes". The Journal of Immunology. 109 (1): 129–135. doi:10.4049/jimmunol.109.1.129. ISSN 0022-1767. PMID 4113792.
  7. ^ "DiaSorin - Annual Financial Report 2017" (PDF).
  8. ^ a b "DiaSorin - Our History". 20 September 2018.
  9. ^ "American Standard's Diasorin Discovers". Archived from the original on 2000-03-01.
  10. ^ "DiaSorin: "Via da Dublino grazie al patent box. Ma ora maggiori certezze"". 16 April 2018. Retrieved 17 April 2018.
  11. ^ "Our history". DiaSorin. 2018-09-20. Retrieved 2020-10-09.
  12. ^ "Borsa Italiana - DiaSorin".
  13. ^ "DiaSorin and Beckman Coulter Form Strategic Partnership to Bring the Liaison XL Hepatitis and HIV Products to the U.S. Market".
  14. ^ "Diasorin and Beckman Coulter form strategic partnership to bring the liaison xl hepatitis and HIV products to the U.S. market" (PDF). Archived (PDF) from the original on 2020-09-19.
  15. ^ "DiaSorin to Acquire Quest's Focus Diagnostics for $300M". GEN.
  16. ^ "DiaSorin Completes Acquistion [sic] of the Focus Diagnostics' Molecular and Immunoassay Product Business from Quest Diagnostics".
  17. ^ "DiaSorin to acquire ELISA immunodiagnostic business portfolio and associated assets from SIEMENS HEALTHINEERS".
  18. ^ "DiaSorin and Meridian Enter Into a Strategic Collaboration to Sell Helicobacter Pylori Stool Antigen Test in the United States and in the United Kingdom" (Press release). 9 October 2018.
  19. ^ "Qiagen, DiaSorin secure US approval for QFT-Plus Test". Verdict Medical Devices. 2019-11-28. Retrieved 2020-04-16.
  20. ^ "TTP plc enters into exclusive licence agreement with DiaSorin to commercialise molecular diagnostics platform". The Scientist Magazine®. Retrieved 2020-10-12.
  21. ^ MeMed (2020-09-08). "DiaSorin and MeMed partner to develop and commercialize novel host immune response based diagnostics solution". GlobeNewswire News Room (Press release). Retrieved 2020-10-12.
  22. ^ "DiaSorin announced the completion of the acquisition of Luminex Corporation" (PDF). Archived (PDF) from the original on 2021-07-14.
  23. ^ "DiaSorin announced the completion of the acquisition of Luminex Corporation". 14 July 2021. Archived from the original on 2021-09-02.
  24. ^ "DiaSorin announced the completion of the acquisition of Luminex Corporation". 14 July 2021. Archived from the original on 2021-09-02.
  25. ^ "Liaison SARS-CoV-2 IgG". DiaSorin. Retrieved 2020-04-16.
  26. ^ "Italy's DiaSorin gets U.S. FDA approval for COVID-19 antibody test". Reuters. 2020-04-25. Retrieved 2020-04-28.
  27. ^ MarketScreener (3 June 2020). "DIASORIN S.P.A. : Stock Market News and Information | DIA| IT0003492391 | MarketScreener". www.marketscreener.com. Retrieved 2020-10-12.
  28. ^ MarketScreener (18 May 2020). "DiaSorin S p A : THE LIAISON SARS-COV-2 S1S2 IGG TEST IS THE FIRST TO RECEIVE THE APPROVAL FROM HEALTH CANADA | MarketScreener". www.marketscreener.com. Retrieved 2020-10-12.
  29. ^ "LIAISON SARS-CoV-2 S1/S2 IgG". Food and Drug Administration. Archived from the original on 2020-05-01.
  30. ^ "DiaSorin LIAISON SARS-CoV-2 IgM Assay". Food and Drug Administration. Archived from the original on 2020-10-30.
  31. ^ "Diasorin receives FDA clearance for the Simplexa™ flu a/b & rsv direct gen II assay: a partner to run with the Simplexa™ covid-19 direct assay" (PDF). Archived (PDF) from the original on 2020-09-23.
  32. ^ "DiaSorin Receives CE Mark to Use Saliva Samples With COVID-19 Test". GenomeWeb. Retrieved 2020-10-12.
  33. ^ "Diasorin Simplexa™ Covid-19 direct molecular test CE marked for saliva specimens" (PDF). Archived (PDF) from the original on 2020-09-25.
  34. ^ "Diasorin's Liaison SARS-COV-2 IgM test receives FDA Emergency Use Authorization for the U.S. market" (PDF). Archived (PDF) from the original on 2020-10-30.
  35. ^ "FDA Grants Emergency Use Authorizations to DiaSorin, NanoEntek, Nirmidas Coronavirus Antibody Tests". 360Dx. Retrieved 2020-10-12.
  36. ^ "DiaSorin High-Throughput, Rapid Antigen SARS-CoV-2 Test Gets CE Mark". 360Dx. Retrieved 2020-11-05.
  37. ^ "fda.gov". Food and Drug Administration. Archived from the original on 2021-06-18.
  38. ^ "DiaSorin releases assay for rapid identification of SARS-CoV-2 variants". Archived from the original on 2021-05-22.
  39. ^ "Press Kit" (PDF). Archived (PDF) from the original on 2020-09-24.
  40. ^ "Press Kit" (PDF). Archived (PDF) from the original on 2020-09-24.
  41. ^ "Annual Financial Report December 31, 2019" (PDF).
  42. ^ "Annual Financial Report December 31, 2019" (PDF). Archived (PDF) from the original on 2021-03-07.
  43. ^ "Qiagen, DiaSorin partnership, 2/18". CAP TODAY. 2018-02-13. Retrieved 2020-10-28.
  44. ^ "BRIEF-DiaSorin and Beckman Coulter form partnership to bring hepatitis and HIV tests to U.S." Reuters. 2016-08-30. Retrieved 2020-10-28.
  45. ^ "DiaSorin, Beckman Coulter sign distribution partnership". CAP TODAY. 2015-09-15. Retrieved 2020-10-28.
  46. ^ a b "Diasorin official website, Total shareholders' basis". Retrieved 15 April 2020.
  47. ^ "Diasorin official website". Retrieved 12 July 2019.
  48. ^ "About us". Retrieved 24 November 2013.
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