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Wednesday, Apr 21, 2004

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When minutes matter

R. Savitha

A US company is developing a device that can reduce the time taken for lab tests on fluids. Here's more on it.

A SMALL US company, HandyLab Inc of Ann Arbor, with Indian scientists on its team, is developing the prototype for a device that will help doctors confirm the presence of infection in fluid samples within 45 minutes of testing. For instance, doctors can confirm the presence of group B streptococci in fluid samples from pregnant women without wasting precious time. The bacterium causes no adverse symptoms in mothers but causes a blood infection in infants.

The device HandyLab is developing, called lab-on-a chip, is set for rollout in US markets by 2005 end. It will be used initially by hospital-based physicians and later by general practitioners for quick, accurate, in-office testing.

HandyLab's story began in 1995 when Kalyan Handique joined the University of Michigan's chemical engineering Ph.D. programme from the Indian Institute of Technology, Mumbai. He joined a lab that was working on microfluidics, a technology that uses microscopic machines to analyse minute quantities of fluid samples. A standard measure in microfluidics is the nanolitre. It takes five million nanolitres to fill a teaspoon.

A year later, another chemical engineering student, Sundaresh Brahmasandra from IIT Chennai, who developed, refined and adapted microfluidics to DNA analysis, joined him. In 1998, Science journal reported on the work being carried out by the two on a tie clip-sized device that could analyse DNA samples.

Currently, the prototype device is undergoing pre-clinical trials in the US to detect infectious diseases and gynaecological disorders. In the future, the device could would work as a cancer marker, help in pharmaco-genetic testing and help diagnose HIV, tuberculosis, malaria and hepatitis, says Nikhil D. Phadke, scientist at HandyLab.

The lab-on-a-chip is a use-and-throw chip that can diagnose illness within 45 minutes of collecting raw fluid samples such as blood, sputum and urine, he says.

The chip's working envisages software-controlled micro-fluidic channels. The raw fluid flows through these channels at the right temperature and the reagents present in the chip give the results that patients are waiting for.

All that the clinician will have to do is carry the chip along with a hand-held device and put a few drops of the collected sample on the chip. Then the testing takes place, and the results are known shortly after, as against the conventional testing for the presence of harmful bacteria that is usually done by culturing the bacterium in a laboratory dish for several days.

While the process sounds easy enough, the company had its share of teething trouble — both with regard to the research and funding.

The company initially had $2.4 million in its first round of venture funding and had to focus on one application that would translate into revenue and profits in September 2000 — and it came out with the group B streptococcal test. In 2002, investors brought in $5.5 million in the second round of funding.

Among its new backers was Hewlett Packard Co, which showed interest in developing a special personal digital assistant (PDA) to drive and control the HandyLab diagnostic cartridge. December 2002 saw the American College of Obstetricians and Gynaecologists issuing new recommendations advising the screening of all pregnant women at 35 to 37 weeks for group B streptococci presence. After that there has been no looking back for the company.

Nikhil says the device can be customised for Indian conditions provided the domestic market shows interest. If that happens, HandyLab will roll out the product for Indian shelves by mid 2007. Along with it will come the PDA from HP that will be `affordably priced.' Currently HandyLab has the IPR (intellectual property right) for the chip in the US and is working on IPR rights for Europe and Japan. Similar rights would be obtained from other countries before its introduction in India, says Nikhil.

rsavitha@hotmail.com

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