Diagnostic Tools for the Masses

Diagnostic Tools for the Masses After developing rapid tests for H5N1 and HIV, can Thai researchers compete with the multinationals? “Anxiety”—that’s how Jittra Cheng describes genetic testing in advance of having a child. “If the results indicated that either my husband or I were thalassemia carriers, it might dash our plans to have a baby forever,” she says. While it’s unlikely that the worry factor can ever be removed, Thai researchers have been able to simplify and increase access to this important diagnostic test. Instead of waiting weeks, couples receive results on their genetic markers for this debilitating blood disease in minutes. Moreover, these rapid tests are more affordable—about $3 compared to $30–40 for laboratory blood work. Thalassemia is common not only in Thailand but also in Southeast Asia, China, India, the Middle East, and in the Mediterranean region. In Thailand, around one percent of the estimated 65 million Thais suffer from the blood disorder, while around 40 percent are carriers of the thalassemia trait. Thalassemia test strips are just one of the point-of-care diagnostic tools Thai researchers have developed recently for commercial use. Others include the world’s first antibody strip test for HIV/AIDS and a rapid test for H5N1 influenza in humans. Prasit Palittapongarnpim, Vice President of the National Science and Technology Development Agency (NSTDA), believes the further development of Thailand’s diagnostics industry can revolutionize disease control among developing countries like Thailand. First and foremost, he points out, the kits save money. Similar to the thalassemia test, those developed for counting CD4 protein for HIV/AIDS patients cut costs by a third, down to $10, because they do not require the use of cytometers. Both cytometers and the reagents used with them are expensive, so only about 30 major hospitals in Thailand are able to have them. Those without have to send blood specimens to hospitals that have cytometers, and wait days for the results. The so-called “CD4 select” was developed by Watchara Kasinrerk, professor of microbiology and immunology at Chiang Mai University, and his team. It can be used with a hematoanalyzer, a common laboratory device found in general hospitals. “Any medical laboratory technician can deal with it,” says Watchara. Diabetes test kits allow patients to monitor blood sugar levels at home, reducing the burden on hospitals and improving patients’ quality of life, particularly those in remote areas. More frequent and effective testing on the front end could also reduce or eliminate treatments downstream. Right now, Thailand spends roughly $100 million on diagnostic supplies, a small fraction of the ballooning budget for pharmaceuticals, says Sirirurg Songsivilai, director of the National Nanotechnology Center. He would like to see this trend reversed. Even greater savings can occur by manufacturing more of these diagnostic devices in Thailand. “Local versions of these test kits could enable us to reduce costs from imported products and develop national sustainability in terms of medical and scientific R&D,” says Sirirurg, who is also cofounder of the diagnostic manufacturer Innova Biotechnology, a joint venture with NSTDA and The National Center for Genetic Engineering and Biotechnology (BIOTEC) and the private sector. But he and many others concede that while the world knows Thailand has the capacity to develop these products, it has not yet developed the capacity to sustain an industry around them. “It makes more sense for Thailand to further develop its point-of-care diagnostics industry because it requires much less investment than the billions of dollars necessary for pharmaceutical research,” says Sirirurg. Moreover, he advises, with additional government leadership, local manufacturers could begin to take a slice of the growing global diagnostics market. The problem, says clinical immunologist Watchara, is that most local companies wait to receive technological transfers in the form of “ready products” from government researchers. Prasit wants to see the government do more to stimulate investment. The $5 million annual fund for diagnostics research at universities and medical institutions is clearly insufficient, he argues. Furthermore, Thailand’s healthcare system lacks policies to promote or prioritize the use of locally made diagnostic tools at public hospitals. Without these ingredients, it’s difficult to get the private sector to improve the quality and effectiveness of test kits. To compete internationally, Sirirurg, adds, Thai companies face even greater challenges. A whole range of additional regulations and standards need to be met, as well as potentially more advanced manufacturing facilities. Domestic companies developing both lab-based and point-of-care diagnostic equipment lack the resources of their international counterparts in the United States and Europe. “The competition gap between multinational and local diagnostic manufacturers is getting bigger. They have much more money and introduce new products more quickly. The government needs to support academic institutions, but also private sector R&D so it can develop and improve product quality,” says Sirirurg. “Otherwise researchers don’t know how long their innovations will last in the market.” Prasit also believes there’s more the private sector could do on its own after receiving technological transfer from R&D agencies, such as develop ways to improve packaging design, and make products more user friendly and attractive to the market. But not all Thai manufacturers are complacent. Komkrit Sajjaanantakul, managing director of I+MED Laboratories, plans to list his diagnostic test company with the Stock Exchange of Thailand. With the new capital, I+MED will establish its own R&D facilities to supplement the technological transfers it receives from governmental agencies. I+MED is currently fulfilling an order for up to 300,000 thalassemia test strips to be used by public hospitals. Iran, which like Thailand also has a high incidence of the blood disease, has expressed interest in purchasing the product as well. Carving out Thailand’s own market segment is essential, stresses Komkrit. He wants to see the necessary government investment to ensure Thai companies can capitalize on the country’s leadership in tropical disease research, especially malaria and dengue fever. “Surely, Thailand cannot compete with Western drug makers or mass producers like China. We have to be more unique and niche oriented. I still believe in this business model. As long as we’re eager to differentiate ourselves, we’ll find opportunities and a solid position for us to stand in the global market,” concludes Komkrit.

Diagnostic Tools for the Masses

Diagnostic Tools for the Masses

After developing rapid tests for H5N1 and HIV, can Thai researchers compete with the multinationals?

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Apiradee Treerutkuarkual

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December 2010

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