Can Regulations Measure up to the Progress of Precision Medicine in Taiwan? – An Interview With Dr. Johnsee Lee

by Joy Lin
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Precision medicine is the opposite of the conventional one-size-fits-all medical approach. Also called personalized medicine, the field takes into account an individual’s genes, lifestyle, and environment before giving them custom-made treatments.  

Molecular diagnostics, which includes genetic testing, plays an indispensable role in precision medicine, displaying a wide variety of uses ranging from detecting diseases to assessing health risks for individuals. 

Precision medicine is gaining traction as healthcare providers acknowledge that every patient tends to respond more favorably to treatments tailored to their specific needs.

GeneOnline recently had the pleasure to interview Dr. Johnsee Lee for his insights on the field of precision medicine and its relevance in Taiwan. Dr. Lee is Chairman of the Taiwan Precision Medical and Molecular Diagnostics Association (PMMD). He is also President and CEO of Quark Biosciences, a diagnostics and precision medicine company.

Related Article: Evolution of Taiwan’s Biotechnology Industry: Policies, Hotspots, and Market Movements


From Diagnostics Platforms to Testing Services 

The molecular diagnostics market is divided into three major components: upstream, midstream, and downstream. The upstream sector involves the development of diagnostic platforms, while midstream and downstream sectors focus on detection reagents and testing services, respectively.

International heavyweights such as Illumina and Thermo Fisher dominate the upstream sector. These companies possess well-established core technologies for genome sequencing as well as the development and manufacture of diagnostic instruments.

For midstream, it is vital that detection reagents can accurately verify biomarkers. They can only be developed with the help of vast quantities of biological information and clinical data. 

Finally, we have downstream testing services. While we require service providers to be well-trained in bioinformatics, there isn’t much room for innovation. Still, this is where most Taiwanese companies in the field reside.

In addition to providing these services, Taiwan’s small and medium-sized enterprises and biomedical professionals could invest more actively in the R&D of midstream testing reagents and kits.

Related Article: How Can Taiwan’s Biopharma Seize the Next Global Business Opportunity? – An Interview with Dr. Jerome Shen


Molecular Diagnosis, a Multipurpose Tool 

We can’t deny that genetic testing has upended our views on how patients receive treatment. In the past, medical practices tended towards “one size fits all” or standardized interventions. Now, we can look at a patient’s genetics to get a comprehensive profile of their disease before designing a treatment plan for them. Truly, diagnosis lies at the heart of personalized medicine. 

Molecular testing does not end with selecting the right drugs for individuals; it can also be used to assess health risks. For example, genetic screening can detect hereditary disease or early signs of cancer, so timely interventions can take place to prevent disease progression.

From a post-treatment perspective, we could use molecular diagnostics to track diseases in real-time. In the case of cancer, a genetic analysis of liquid biopsy samples taken from the patient can yield valuable information on the changes happening in their tumors or predict whether a cancer is likely to recur.


A Window of Opportunity for Precision Medicine in Taiwan?

Taiwan is not the fastest when it comes to accepting emerging medical technologies such as molecular testing. Current regulations limit the rollout of services, which must undergo a lengthy review and show clinical proof of concept to be eligible for reimbursement schemes under the health insurance system. Furthermore, there aren’t enough collaborative opportunities between the diagnostic developers and medical practitioners who perform testing services.  

The emphasis on personalized medicine is growing, and so too is the market for molecular testing. According to a MarketsandMarkets estimate, the global molecular diagnostic market will reach $31.8 billion by 2026. To secure a slice of that pie, Taiwan will need to make its laws and regulations more open and responsive.

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