Support programs are developing a strong industry but access to qualified staff remains an issue, says Geneflux Director and biotechnology entrepreneur Dr. Prashanth Bagali

by Jon Southurst

It’s been over four years since the Malaysian government formed the Malaysian Biotechnology Corporation (BiotechCorp), an agency tasked with turning Malaysia’s infant biotechnology sector into a global competitor. BiotechCorp is achieving this with a comprehensive array of programs providing everything from education to entrepreneurial support, investment, training and marketing. Large companies and niche players alike would get the kind of assistance they needed to expand internationally. Geneflux™ Biosciences is one company that took its concept global with a focus on local issues under BiotechCorp’s guidance. Dr. Prashanth Bagali, its Director and co-founder, spoke to us about his company’s experience and the challenge for Malaysia in the 21st century’s preeminent scientific sphere.

The term ‘biotechnology’ refers to the science of life itself. It includes research and techniques involving living organisms from microorganisms to plants and animals, to serve specific applications in improving human health and agriculture. At its cutting edge is genome mapping, cell fusion, gene detection, gene transfer and embryo manipulation. It’s a prestigious, high-value industry with rewards in intellectual property, international sales and reputation among the world’s scientists.

The national interest in biotechnology started as early as the 5th Malaysian plan (1986-1990) but was given due recognition and emphasis starting from the 8th Malaysian Plan (2001-2005).  Before 2007, healthcare biotechnology in Malaysia was an embryo itself. The existing industry was driven by traders, equipment suppliers and reagent vendors, with less than 100 local patents filed of any international importance. That was around the time BiotechCorp was just beginning, and it was into this scene that entrepreneurs Dr. Bagali and partner Ir.Balagaru Naidu arrived to set up a business.

Biotech entrepreneurs and Geneflux founders, Dr. Prashanth Bagali & Balaguru Naidu

Biotech entrepreneurs and Geneflux founders, Dr. Prashanth Bagali & Balaguru Naidu

Geneflux Biosciences registered in 2007 with a focus on the research and development of Polymerase Chain Reaction (PCR) based testing kits, a faster way to detect and analyze small quantities (or volume) of DNA or RNA without the need for full cloning. Their kits would be available at affordable prices to developing countries in Asia and Africa, vital in combating diseases affecting those regions.

“We decided to convert (Malaysia’s 2007) liabilities into opportunities,” said Dr. Bagali, an Indian national. “The problem was, there was a longer turn-around time of more than two weeks for dengue serotyping, Hepatitis B and Human Papillomavirus (HBV/HPV) genotyping, and HIV quantitation for patients who were suffering in ICUs, quarantine wards, organ transplant and infection control zones. Prices of tests at the time were very high and not affordable by middle and low income groups.”

“Surprisingly, many critical PCR tests were sent overseas (Singapore, Australia, India, Thailand, Hong Kong) for validation,” says Dr. Bagali. “Geneflux changed the landscape of the industry by reducing turn-around time to just a few hours for dengue, chikugunya, influenza A and H1N1 PCR tests.”

With PCR based diagnostic kits, test reports for Hepatitis B and C viruses and Herpes simplex (HSV) can now be despatched to doctors and hospitals within 2-3 days around Kuala Lumpur, Klang Valley, Putrajaya, Negari Sembilan, Johor and Penang.

Geneflux is the first local manufacturer of such molecular diagnostic kits in Malaysia. Previously, universities and their laboratories developed separate products for hospitals without certification or Standards Malaysia accreditation. In fact, even after developing the kits the researchers found the Malaysian Medical Devices Bureau did not actually have a system to register the products, leaving the company to wait for a ‘free sale certificate’ to find markets overseas first.

Bagali and Naidu, with their “passion for science and science in action,” have grown their business to 20 employees, 12 science staff and eight support and administrative staff. Geneflux is now registered in Malaysia, India, USA and UK. The directors and founders have together invested about US$1 million on human resources, infrastructure, international business development and marketing.

BiotechCorp and the Malaysian Ministry of Science, Technology and Innovation (MOSTI) also supported the growing business through funding programs. With their assistance, Geneflux built a state-of-the-art molecular diagnostic laboratory in Malaysia in 2009 after receiving official ‘BioNexus status’ in 2008.

BioNexus status for companies confers economic privileges like total freedom of ownership and the ability to source funding and skilled workers from overseas. Opportunities for additional funding is another benefit, and Geneflux’s status saw it receive RM815,000 (US$275,000) for the pre-commercial development of MyDENKit and clinical trials at eight international research centers across dengue epidemic regions.

For the successful completion of the dengue project, MOSTI gave Geneflux its Certificate of Achievement and, in 2009, BiotechCorp awarded another RM2.5 million ($843,000) and enabled the company to become “champions in molecular diagnostics production and services.”

Even with generous government support, the Malaysian biotechnology industry will struggle to reach its full potential unless companies have ready access to qualified staff, both experienced and university graduates. Finding staff at higher levels has presented some difficulties:

“Qualified staff with PhDs in Genetics, Biochemistry or Molecular Biology, Medical microbiology and post-doctoral experience are lacking at large,” says Dr. Bagali. “This will become a great hindrance to the further expansion of healthcare biotechnology in the growing Malaysian economy towards the year 2020.”

Staff such as low to middle executives, as well as biotech scientists, also require extra training to reach internationally-accepted standards, he added.

 

Geneflux’s competitive edge now comes from being both a manufacturer and service provider of molecular diagnostic kits. The company has four PCR-based diagnostic kits: MyDENKit™ (dengue virus and serotyping), MuRSAFlux™ (Methicillin resistance staphylococcus aureus identification), FluFinder (H1N1 virus identification) and a Chikungunya (CHIKV) virus detection kit.

They also have ten years’ exclusive license for patents of Melioidosis detection (caused by Burkholderia pseudomaleii), CMV (Cytomegalo virus) detection and dengue virus quantitation. The core business revolves around qualitative and quantitative molecular diagnostic services for Hepatitis B, Hepatitis C, HSV1 and 2 (human herpes simplex virus), VZV, HIV, JC virus, BK virus and other infectious diseases caused by viruses and bacteria.

Consultants Frost & Sullivan  recognized Geneflux with its 2010 Asia-Pacific Niche Company of the Year Award in Molecular Diagnostics. The company is also enrolled in the RCPA Quality Assurance Programs Private Limited in Australia and have participated in inter-laboratory quality assurance schemes conducted by Malaysia’s Institute of Medical Research (IMR).

 Tokyo, Japan 2011/9/9