Polyclone Bioservices, a nascent biotechnology enterprise will set up a Nucleic Acid Testing facility next month in Bangalore. This will allow medical centres in Karnataka to outsource NAT services through Polyclone. The pilot unit of NAT is already located at University of Agricultural Sciences, Dharwad. The company is collaborating with several pathology groups and currently analyzing the market to come out with the right strategy to bring out the best possible assays for the Indian market.
NAT also called DNA/RNA based diagnostics is a rapidly growing market and a gold standard for diagnosis of several infectious diseases like TB, HIV and HCV.
The company has initiated dialogue with the Public Health groups in Australia to transfer technologies for detection of certain pathogens. Initially, Polyclone will start with TB, HIV and HCV assays and later scale up for other complex infectious diseases. The major objective is to bring down the cost and speed of diagnosis by more than half, stated Naveen Kulkarni, CEO, Polyclone Bioservices.
The business of NAT is a low volume high value business. Polyclone will look at labs and hospitals to outsource the service from them.
"In the wake of sudden epidemic attack, a biotechnology company like ours can rapidly derive assays in a shorter span of time to develop tests to accurately detect the pathogen and its sub class," stated Kulkarni.
Conventional diagnostic methods such as cell culture, antibody testing, and even symptomatic diagnosis is uneconomical in terms of time and cost. A polymerase chain reaction (PCR) test only takes 30 minutes to deliver results and requires minimal staff training and expertise due to its simple operations.
The advantages of NAT are its high level of analytical specificity and sensitivity. Detecting specific nucleic acid (DNA or RNA) sequences is a direct method for the identification of a pathogenic organism and more specific in comparison to identifying antibodies or antigens in serological assays. In addition, nucleic acid assays have the capability to detect or monitor a single cancer cell, micro-organism, or as few as 50 copies of DNA/RNA (viral load). The procurement of the sample is less invasive in comparison to biopsies.
NAT has certain limitations which makes it prohibitive for small laboratories. Target amplification techniques produce copies of the target sequence, which could contaminate other specimens. It requires additional laboratory space, equipment, safety apparel, and/or built in anti-contamination reagents, which makes it expensive. Also NAT is a high complexity testing; calling for appropriate expertise of the lab personnel.