The Surat-based Span Diagnostics (SDL) has introduced a multiple allergy diagnostic test in the Indian market. The in-vitro allergy diagnosis system, titled as MAST CLA, is developed and manufactured by Hitachi Chemical Diagnostics Inc. SDL, which currently manufactures and markets a very comprehensive range of readymade diagnostics reagents, accessories and instruments needed by the clinical pathology laboratories, will be the sole distributor of MAST CLA in India.

Launching the product in Mumbai, Veeral Desai, executive director, SDL said that this new multiple allergy diagnostic system is the most sophisticated test available in this segment, as it uses the chemiluminescence technique and modified test methodology.

The MAST CLA can identify up to 36 different allergic reactions in a single sample as it contains a panel of similar number of individual allergens coupled to a cotton thread solid phase. With MAST CLA, the test performed by drawing the patient sera into the reaction chamber for incubation and a secondary antibody, anti-human IgE coupled with an enzyme is then incubated along with the allergen anti bogy complex, which is followed by addition of a substrate and a chemiluminscent reagent. The signals generated through the chemical sensitivity of this panel are read by an analyzer to determine the concentration of IgE specific antibody attached to the solid phase.

However, he added, the panel testing seems to be particularly useful in the early steps of allergy evaluation because of the high negative predictive value. Having an average of 90 per cent accuracy, the diagnostic test has been approved by the DCGI recently for marketing in the country. The company expects a turnover of Rs. 1.5 crore in the first year with this multiple allergy diagnostic test in the Rs. 600 crore diagnostics market.

Promoted in 1972, SDL has currently grown in size to establish a dominating presence in the Indian diagnostics market, and is today the largest indigenous manufacturer in this segment. At present, the company has distribution rights of various multinational companies such as Abbott, Genbio, Corgenix, ICN, Hitachi, Biotechnica, ACCI, Equibiotech and Nihon Kohden.

Span's most recent introductions in rapid test segment include ParaHIT-f and Signal HCV, kits meant for the detection of falciparum malarial parasite and hepatitis C virus. The technology for malarial kit has been developed by the Program for Appropriate Technology in Health (PATH), USA, and funded by USAID. Besides, Span is already marketing Combaids-RS, a rapid immunodot assay for HIV detection for which the technology was also transferred from PATH. It is the only test in its segment, which is approved for screening purpose in blood banks. NACO has recently procured 8 lacs of Combaids tests, to be used at National level for screening blood donors.

In the field of other infectious diseases, the company already manufactures tests for brucellosis, typhoid, syphilis, and tuberculosis. Further development of more sensitive and accurate tests for the diagnosis of typhoid, tuberculosis and kala-azar are currently under progress. It is hoped that these newly developed products will hit the market in 2002.

In the area of cancer diagnostics, SDL has recently introduced a range of 16 monoclonal antibodies, produced in-house, for immuno-histological diagnosis of various types of malignant tumors. The company currently operates in the market through its four strategic marketing divisions such as Popular Diagnostics Division, which caters to the largest customer base by offering most widely used diagnostics products, commonly required by all segments of the industry, Stimulus Specialty Diagnostics, markets premium specialty products of highest quality, manufactured either indigenously or through imports, Nexus, caters to industrial and research product division dedicated to pharmaceutical industries and research institutes and Span id, a strong presence in clinical instrument segment with a unique combination of application expertise and engineering capabilities.

Its Export Division has already made a noteworthy presence by sending out the indigenously made products to several countries in the world. The facilities of SDL have been accredited for ISO 9002 Quality Management systems by SGS International Certification Services. For the company, this certification came in the wake of the GMP approval as per the WHO guidelines, for it is manufacturing facilities. At present, SDL is the only company in diagnostics sector in India to have both these certificates. The company has plans for progressive indigenisation of many other specialty test kits, which are presently imported for the domestic market.