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SPOTLIGHTS
A Quest Fulfilled: A Revolutionary Dye for Diagnosing Tuberculosis
An interview with Ruby E Dewi, General Manager of MediLux Biosciences, on tuberculosis’s prevalence in Asia, the young company’s mission to reduce the burden of infectious diseases, and how its novel dye would be a gamechanger for tuberculosis diagnosis.

While governments turn their attention and resources to managing the COVID-19 pandemic, other diseases seem to have taken a back seat. One such disease is tuberculosis (TB), which continues to be one of the top 10 deadliest diseases in the world.

According to the World Health Organization, the South-East Asia region including India, South Korea, and ASEAN countries, is home to about a quarter of the world’s population and yet, accounts for nearly half the global burden of TB. While the global TB incidence has been falling at 2 per cent per year, worldwide lockdowns caused by the ongoing pandemic has slowed down the rate of TB diagnosis and enrolment for treatment.

In this interview, we have Ruby E Dewi, General Manager of MediLux Biosciences, a Singapore-based subsidiary of the US-based parent company, OliLux Biosciences, Inc. to share more about how the pandemic has affected TB research and how MediLux Biosciences is solving TB diagnosis problems through its key technology.

As COVID-19 brings the world to a standstill, how has the pandemic affected TB research efforts?

Interestingly, it has been like a cloud with a silver lining. As the COVID-19 virus spread like wildfire, much of the world’s resources for managing diseases such as TB were diverted away towards COVID-19 containment and treatment efforts. This was exacerbated by the COVID-19 lockdowns that many countries imposed, which made it difficult for TB patients to receive diagnosis and treatment.

In 2020, around 14 million TB patients failed to receive adequate treatment, reported TB-related deaths increased by half a million compared to 2019, and another half a million patients were diagnosed with drug-resistant TB.1 On top of that, the StopTB Partnership also estimated that the global three-month lockdown could add 6.3 million cases of TB between 2020 and 2025, which threatens to unravel the progress made in the past decade towards WHO’s goal of eradicating TB by 2035.2

But while it was undoubtedly a tough year for both TB research and TB patients, the silver lining comes from the fact that the pandemic highlighted just how severe the impact of highly infectious diseases can be. COVID-19 and TB share some similarities in that they both mainly affect the lungs and the respiratory system and are highly transmissible through person-to-person contact. The race to identify rapid yet accurate COVID-19 diagnostics, as well as the development and uneven distribution of vaccines, runs parallel to the challenges faced by TB researchers.

This renewed attention to transmissible infectious diseases – such as TB and COVID-19 – is much needed. At MediLux Biosciences, we hope that this heightened awareness will also translate into reignited research efforts to fight TB globally.

MediLux Biosciences is a young company, only being incorporated in December 2019. Could tell us a little more about the company, its vision, and how it hopes to positively impact society?

MediLux is the Singapore subsidiary of our US-based parent company, OliLux Biosciences, Inc. OliLux was established in 2019 as a public benefit corporation with a mission to leverage scientific innovation to create affordable, simple, and reliable solutions for managing infectious diseases in resource-limited settings.

MediLux Biosciences envisions a world where scientific innovation is leveraged to solve the world’s toughest health problems in all corners of the globe. Our mission is to reduce the global burden of TB and other infectious diseases by providing rapid, mobile solutions for disease detection and monitoring for anyone, anywhere.

TB is a disease that primarily affects the respiratory system and is spread through close contact with patients. Rapid, accurate and affordable detection and diagnosis is key to stopping further spread of the disease – especially as many TB patients live in resource-limited countries and regions – as well as significantly reducing TB’s global burden, including an estimated US$1 trillion world economic burden.3

At MediLux, we hope to positively impact society through our diagnostic tools and technologies for infectious diseases, and TB is our first focus. Our first key technology, DMN-Trehalose, was developed to fill the need for fast, accurate, and cost-efficient diagnosis for TB patients. In the future, we plan to expand our portfolio to include diagnostics for other infectious diseases.

Despite being initially established in the U.S., we were quick to notice that we could more positively impact the field of TB research and the TB community in general if we were to establish our main operations in a geographically more relevant and strategic location. Understanding that the WHO South-East Asia region carries about 45 per cent of the global TB burden,4 we established MediLux Biosciences here in Singapore to work more closely with TB researchers in the area and more directly address the needs of the region.

As a manufacturer of medical research and clinical diagnostic instruments and supplies, could you elaborate more on how your novel solvatochromic dye would aid in TB diagnosis problems, and how it differs from other diagnostic tests like the TB skin test and TB blood test?

Currently, two of the most commonly used methods to diagnose TB are sputum smear microscopy (SSM) and the nucleic acid amplification test (NAAT, which includes techniques like PCR). For SSM, a chemical named Auramine-O is the most commonly used dye because it is very affordable, but unfortunately, it is both highly non-specific and highly inaccurate. Meanwhile, the GeneXpert system (Cepheid, USA) is the most established of all the NAAT methods and provides a rapid, accurate diagnosis of TB, but is usually cost-prohibitive for patients in resource-limited settings.

With our novel solvatochromic dye, DMN-Trehalose (DMN-Tre), we aim to bridge the gap and address the clinical need for a TB diagnostic tool that is rapid, accurate, and affordable. Compared to other SSM dyes, DMN-Tre has enhanced accuracy and a streamlined protocol, which significantly reduces processing time. It was rationally designed to hijack the molecular machinery of mycobacteria and fluoresces only when it comes in contact with live, metabolically active Mycobacterium tuberculosis (Mtb., the bacteria that causes TB). Hence, the dye can distinguish between live and dead Mtb. No other currently available dyes can do this, and we are currently leveraging this inherent trait to develop a treatment monitoring and drug susceptibility assay for TB.

Our solution differs from the regular TB skin test (TST) in several ways. Firstly, DMN-Tre provides diagnostic results within hours, instead of the two to three days required for the TST to develop. Secondly, DMN-Tre illustrates clear positive (or negative) results of active TB infection, whereas there can be difficulty in interpreting TST results – especially in ‘double redness’, a commonly cited issue even among healthcare professionals. Lastly, DMN-Tre will not yield a positive test as a result of a recent BCG vaccination or booster shots.

With regards to the TB blood test (IGRA), the DMN-Tre generates results more quickly and at a much lower cost than IGRA. IGRA can provide results in 24-48 hours compared to DMN-Tre’s track record of a few hours. Additionally, DMN-Tre costs about US$2 per test, whereas the cost of one test is US$55.08 for QuantiFERON-TB Gold-in-Tube and US$46.61 for T-SPOT-TB, the two IGRA TB tests that are currently FDA-approved for use.

What are some of MediLux Biosciences’ other developments and achievements?

Since our initial publication in Science Translational Medicine,5 the applications and practical utility of the DMN-Tre technology have been demonstrated in several peer-reviewed scientific publications and featured in several prominent news outlets such as the Howard Hughes Medical Institute news, HuffPost South Africa, and Chemical & Engineering News (C&EN). We are honoured that other TB researchers and the TB community in general are excited about our technology.

Some of our more recent achievements include a US$400,000 funding from OpenPhilanthrophy, a philanthropic foundation whose goal is to improve lives through research and grant-making. These funds helped us kickstart our operations in Singapore and will support a new project that expands the use of our dye for treatment monitoring and detection of drug-resistant TB.

We also have a planned collaboration with the Singapore DxD Hub on the development of a direct TB detection test. Additionally, we were shortlisted for the Singapore DxD Initiative award – this was put on hold during the pandemic, but we are looking forward to progressing our collaboration further in the near future.

Being based at NSG Biolabs, a co-working laboratory designed specifically for biotechnology-related start-ups, why did MediLux Biosciences choose Singapore as its research and breakthrough destination and how would the company contribute to Singapore in becoming a biotechnology hub in the region?

As mentioned earlier, the WHO South-East Asia region shoulders nearly half of the global TB burden. Although Singapore itself has only a small number of TB cases, its central location in the heart of Southeast Asia and its reputation as a biotechnology hub made it a natural choice for us to set up our research and development (R&D) headquarters here.

Singapore is a strategic location from which we can ship our products to other countries in the region and beyond. Its close working relationship with other ASEAN countries (five of which are in the top 20 of WHO’s high burden countries) also means that we can create more meaningful collaborations and hopefully, a greater positive impact in TB research in this region.

Singapore’s thriving biotechnology ecosystem was another big draw for us. The DxD Hub has been an important partner for us in establishing a baseline for the types of TB research that are ongoing in Singapore and the wider Southeast Asian region. They have also connected us with healthcare teams from other ASEAN countries.

As part of that ecosystem, we fostered a crucial partnership with NSG BioLabs in Singapore, the country’s largest fully equipped co-working laboratory that is designed as a revolutionary incubator. As a young subsidiary company, we were operating on a lean model and the space, resources and support offered by NSG BioLabs has been invaluable. That, coupled with its strategic location in Biopolis, meant that MediLux has the kind of infrastructure and administrative support commonly found only in large academic institutions and pharmaceutical companies simply by being housed in NSG BioLabs.

Overall, MediLux is looking forward to contributing to Singapore becoming a hub for TB research and manufacturing activities in the WHO South-East Asia region, further cementing its reputation as a biotechnology hub.

Given that half of global TB deaths are from South-East Asia, why do you think this is so and are there any relevant regional organisations and/or governments that MediLux Biosciences plan to collaborate with to alleviate the number of TB cases?

Since TB is spread mainly through person-to-person contact, it is much more common in low-middle income countries (LMICs) as it is more likely for people in these countries to live and work in overcrowded and poorly ventilated conditions. Delayed TB diagnosis also exacerbates the spread of the infection as a patient can unwittingly infect other people around them. These, combined with poor nutrition and other co-morbidities such as HIV, make LMICs a larger contributor to the global TB burden. More countries in Asia and Africa are LMICs, which naturally see more TB cases and deaths.

We are currently actively searching for academic and industry partners to collaborate with in further developing our current technology as well as investigating new ones. We are also looking into the various government grants and initiatives that are available in the region to combat TB. Some disease-specific grants provided by regional organisations and governments are only available to academic TB researchers and their partners, so we’re currently working on identifying TB researchers in Singapore and the region who would be a great fit with us and our research portfolio.

In Singapore, we’re looking forward to restarting our proposed work with the DxD Hub. We’ve also had a number of meetings with TB researchers and clinicians, as well as pharmaceutical companies, in Indonesia to identify possible avenues of collaboration. Our (virtual) doors are always open for new collaborations and we are excited for more partnerships to come through. Interested parties should reach out to us!

References

  1. Haseltine, W. A. (2021, May 3). Covid-19 and tuberculosis: A deadly combination - we can do better! Forbes.
  2. Stop TB Partnership. (n.d.) The devastating effect of the COVID–19 pandemic on the TB response - A minimum of 5 years of progress lost and 6 million additional people ill with TB [Press Release].
  3. Burki, T. K. (2018). The global cost of tuberculosis.  The Lancet Respiratory Medicine, 6(1), 13.
  4. World Health Organization. (n.d.). Tuberculosis. World Health Organization. Retrieved from https://www.who.int/southeastasia/health-topics/tuberculosis.
  5. Kamariza, M., Shieh, P., Ealand, C. S., Peters, J. S., Chu, B., Rodriguez-Rivera, F. P., ... & Bertozzi, C. R. (2018). Rapid detection of Mycobacterium tuberculosis in sputum with a solvatochromic trehalose probe. Science translational medicine, 10(430).

About the Interviewee

Ruby Dewi is the General Manager for MediLux Biosciences, Pte. Ltd. She is a scientist, a writer, and a passionate advocate for the fight against TB. She can be reached at ruby@oliluxbio.com.

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