The Pune-based Geneombio Technologies Pvt Ltd (GTPL), a contract research organization providing customized DNA-based service in human and livestock health segments, has received certification from the TREAT Asia Quality Assessment Scheme (TAQAS) for its indigenously developed HIV Drug resistance assay.

The company, which has participated in the evaluation programme of TREAT Asia (Therapeutics Research, Education, and AIDS Training in Asia) a network under the aegis of World Health Organisation (WHO), has conducted tests in both bioinformatics and wet lab capabilities successfully, according to Sachin Purohit, managing director, Geneombio Technologies. The company is the only private firm from India participating in the TREAT Asia programme among the 15 labs selected across Asia.

TAQAS, the external quality assessment scheme programme run by the National Reference Laboratory, Australia under TREAT Asia Network, is to enable the laboratories in the Asian region to perform HIV genotypic resistance testing for this surveillance and patient management.

With the approval, the company can test assays for the TREAT Asia Studies to Evaluate Resistance (TASER), a programme to evaluate HIV drug resistance (HIVDR) and build capacity for surveillance and monitoring of resistance in Asia, and would be able to provide testing services to the drug companies and physicians in Asia.

"The certification will enable us to be a part of a lot of studies in Asia and particularly in India. The drug companies and even the medical practitioners engaged in anti-retroviral treatment (ART) can improve their treatment and drug development options based on our test results," said Purohit.

The HIV resistance testing is a key factor in limiting the adverse effect of HIV drug resistance, he added. The assay assists the clinician to choose the drug or drug combinations that will have the greatest chance for success thus reducing the HIV viral load within the shortest possible time. HIV drug resistance assay (also known as genotypic assay) detects mutations that cause drug resistance.

TREAT Asia, a network of clinics hospitals and research institutions working to ensure the safe and effective delivery of HIV/AIDS treatments throughout Asia and the Pacific, is aimed to facilitate surveillance for antiretroviral (ARV)-resistant HIV-1 virus across subtypes and to monitor the development of resistance in individuals receiving ARV therapy. Currently, Y R Gaitonde Centre for AIDS Research and Education (YRG CARE) - the Chennai-based non-profit organisation - is the only participant from India in the TREAT Asia Network.

Considering the difficulties to market assays in the current form, the company is currently in a process of developing HIV drug resistance kits to grab a bigger market both in India and Asian countries. The product, which would be compatible with any PCR machine, will be ready for launch in the next three months, informed Purohit.

A few imported HIV drug resistance test kits are available in India at present, including Viroseq HIV genotyping system from Applied Biosystems (formerly PE Biosystems), Trugene from Applied Sciences and INNO-LiPA HIV-1 RT and INNO-LiPA Protease from Bayer Diagnostics.

"These assays from international manufacturers are expensive to use and are difficult for common man in India requiring the assay to avail because of economic reasons. In this context, our HIV drug resistance test provides a viable alternative as an economical assay with internationally assured quality. Prices of our test assays are almost 50 per cent less than the imported assay," he said. With the TAQAS approval and the launch of the kit, Geneombio's diagnostic division is expected to have a 200 per cent growth. However, he refused to reveal more on the financials of the company.

The company is also planning to get certification on its Tuberculosis drug resistance assay and Hepatitis B virus drug resistance assay from the WHO soon. The company has registered the products for tests in the Australia-based National Reference Lab and is pursuing approval for bringing in the test on par with the WHO standards.