The products that the Diasorin Group develops and distributes exclusively for use in clinical diagnostics are used both in diagnostic laboratories located inside hospitals and in those that operate independently of such facilities (private service laboratories). They are generally used to assist physicians in diagnosing various pathologies (diagnostic value), determining the progress of diseases (prognostic value), or assessing the effectiveness of drug treatment (monitoring).

Product Lines

Thanks to its ability to access a number of different technologies, Diasorin is able to produce almost all of the raw materials it needs to formulate the active principles contained in its products. Specifically, it is capable both of obtaining recombinant antigens and growing cell lines (hybridomas) for production of monoclonal antibodies.

The process used to manufacture these raw materials includes phases during which large quantities of the bioreagents are obtained with fermentation or cell culture techniques (so-called upstream phases) and phases during which the bioreagents undergo several purification steps to separate the desired protein or monoclonal antibody from the cell components of the host organism (so-called downstream phases).

The high technological and innovative content brought to bear in the research and development process and the large-scale production of the biological raw materials that constitute their basic active ingredients enable Diasorin to offer one of the broadest product menus available on the market today. The product menu combines the more commonly used tests with the specialty products that have given the Diasorin line its distinctive character and enabled the Group to achieve leadership positions in the market segments in which it operates.

The availability of comprehensive menus for the different clinical areas enables Diasorin to offer customers a one-stop solution for their needs and helps them reduce the number of their suppliers. At the same time, specialty tests are unique to the Group and serve to differentiate the Diasorin product line from those of its competitors.

Diasorin produces and distributes immunoreagent kits used to diagnose numerous diseases in the following clinical areas:

Oncology: Tumor diagnostics;

Thyroid dysfunctions: Thyroid dysfunction diagnostics;

Fertility tests: Measurement of the release of female hormones before and during pregnancy;

Hormonology: In general, measurement of hormones associated with diseases that are not included in other clinical areas (e.g., obesity, diabetes, etc.)

Autoimmune diseases: Diagnostics in the area of diseases caused by a malfunction of the autoimmune system that causes the production of antibodies that attack targets that are part of the body (tissues, joints, etc.) instead of intruders;

Infectious diseases: Diagnostics in the area of diseases caused by non-viral pathogens (bacteria, protozoa, etc.);

Heart diseases: Measurement of hormones and molecules associated with heart muscle dysfunctions;

Viral diseases: (hepatitis, AIDS, other viruses): Diagnostics in the area of diseases caused by viral pathogens.

The technologies that the Group uses and has established as the foundation for the development and production of its entire product line reflect the technological path followed by the immunodiagnostics market since the 1960s. Specifically, there are three primary technologies:

RIA (Radio Immuno Assay): This is a technology that uses radioactive markers and is currently employed primarily for some products capable of providing results that cannot be delivered by other technologies. It does not enable the development of products that can be used with automated testing systems and equipment, but only with products for tests that have to be carried out manually by experienced technicians.

ELISA (Enzyme Linked ImmunoSorbent Assay): Introduced in the 1980s, this is a non-radioactive technology in which the signal generated by the marker is colorimetric, and which primarily makes it possible to develop products in the microplate format. Products based on the ELISA technology use reagents locked in microtitle plate dispensers or packaged in separate vials, often in the form of liquid concentrates that require a minimum of handling before they are ready for use. As a result, even though partly automated analyzers can facilitate some phases of the testing process, some manual work is unavoidable. When using products that are based on the ELISA technology, the test time (i.e., the time needed to complete the test of a biological sample) can be as long as three to four hours.

CLIA (ChemiLuminescent Immuno Assay): This is the latest generation technology that appeared in the early 1990s. Here, the signal is generated by a marker marked with a luminescent molecule; the CLIA technology can be adapted to products and instruments with features offering a high level of usage flexibility in terms of menus and the performance speed of the test. Unlike ELISA, the CLIA technology has made it possible to shorten the required time (30 to 45 minutes) and has been used by diagnostic companies to develop products in proprietary formats (that is, non-standard formats) capable of working only on the system developed specifically for those products (so-called closed systems). Unlike products that use the ELISA technology, the operator is not required to perform any action on the product, which comes in its “ready-to-use” form. All that the operator has to do is load it into the appropriate location on the dedicated equipment.

Diasorin uses all three technologies. The table that follows provides an overview of the technologies and clinical areas covered by the current Diasorin product line:

Clinical Area	Technology
	RIA	ELISA	CLIA
Thyroid dysfunctions/ Fertility tests/ Hormonology	√		√
Oncology	√		√
Viral diseases/Infectious diseases		√	√
Heart diseases			√
Autoimmune diseases		√	√

Equipment

Diasorin also supplies its customers with equipment that, when used in combination with the reagents, makes it possible to carry out the diagnostic investigation automatically.

In the 1980s, the market for in vitro diagnostics began to develop a need for automated diagnostic systems and tools due to a surge in the volume and variety of tests that diagnostic laboratories were being asked to perform. The market increasingly demanded access to automatic analyzers that, once the vial with a patient’s biological sample (blood, urine, etc.) was loaded into the system, could perform the desired tests automatically using the components of a reagent kit, performing a procedure that previously was performed manually by an operator. There are two basic types of immunodiagnostic equipment:

Open systems, which were developed in the early 1990s and allow semiautomatic operation with products based on ELISA technology. Generally, thanks to the level of automation offered by these systems, operators are required to make only a limited effort to use products based on ELISA technology that are manufactured by different producers (hence the name “open systems”).

Closed systems, most of which are currently based on the CLIA technology and are designed for fully automated test processing of a biological sample. The format of the product used is such that the system is accessible only to the company that developed it and supplied it to its user (hence the name “closed system”).

Diasorin offers two types of equipment:

The ETI-MAX, which is used for products delivered in the microplate dispenser format. This system, which is based on the ELISA technology, performs the test process automatically or semiautomatically and can be made to interface with a laboratory’s management software for the direct delivery of the test results. It is called a batch analyzer, meaning that tests can be performed only on samples that have already been grouped according to the desired test. With a menu of more than 70 available tests for infectious diseases, autoimmunity and viral hepatitis, a load capacity of 240 samples and barcode-based reagent management, it is one of the most complete and flexible systems available on the market.

The LIAISON which is the Group’s top system. LIAISON offers total automation of the testing process in random access mode (any assay, at any time, in any sequence) and uses products developed using CLIA technology, which are packaged in a proprietary format, making the equipment a closed system. With a menu of over 70 tests in the clinical areas of infectious diseases, autoimmunity, endocrinology, fertility, phospho-calcic metabolism, oncology and heart diseases, it is one of the most complete systems in the immunodiagnostic sector. The diagnostic kit used on the LIAISON is manufactured by Diasorin in cartridges, each of which contains 100 tests for the same disease. The cartridge is loaded into the appropriate location and used until all of the reagents it contains have been utilized. The LIAISON has a maximum output of 180 tests per hour and can be loaded with up to 15 refrigerated reagent cartridges.