Molecular diagnostics company Inex Innovate is built on making an early mark. In 2020, the company had its clinical laboratory and wholly-owned subsidiary iGene Laboratory pivot to become one of the first privately-owned labs to run Covid-19 polymerase chain reaction (PCR) testing in Singapore.
iGene Laboratory also developed the FastCoV® reverse transcription (RT)-PCR test service, which provides results in as short as four hour — the fastest in Singapore — and has helped test hundreds of thousands of patients for Covid-19. In addition to processing RT-PCR testing, Inex launched its Covid-19 PCR reagent CORO® kit, which was granted provisional authorisation for use by the Health Sciences Authority (HSA) and rapid antigen testing (ART) solutions.
With the pandemic past its peak, Inex has been able to return its focus to addressing unmet clinical needs in women’s and foetal health, says CEO Kane Black in an interview with The Edge Singapore. “Our vision is to make technologies accessible to women across Asia and worldwide. We aim to give women and mothers greater certainty and confidence in diagnostic testing.”
Winner of the EY Singapore Entrepreneur of the Year Award for the Biotechnology sector, Black says that the experience Inex gained from its pivot into Covid-19 testing has helped the company expand into other infectious disease testing services at its iGene Laboratory, while the skills its team developed will enable the delivery of new laboratory platforms and workflows that will continue to be employed post-pandemic.
Inex — the first such company in Asia for women — began its foray into offering medical solutions for a largely underserved market as a spin-off from the National University of Singapore (NUS) in 2019. The company was founded by practising obstetricians, gynaecologists (OBGYNs) and key opinion leaders in foetal-maternal care and oncology.
Inex works with global centres of scientific excellence, such National University Hospital (NUH), NUS and the Agency for Science, Technology and Research (A*Star) in Singapore, as well as with institutions abroad, including the Chinese University of Hong Kong (CUHK) and St John’s Cancer Institute in the US. Their clients include clinicians, hospitals and laboratory partners across Southeast Asia.
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Democratising diagnostics in Asia
Black says the company’s ambition is to “democratise diagnostics” by making these medical procedures more accurate, available and affordable to the public. “The genesis of our company was to develop tests which make it easier for people toget tested with patient-friendly options.”
Inex says healthcare involves two crucial points: Diagnosis and treatment. However, an issue facing women’s health across Asia is low screening participation rates, which results in late-stage diagnosis and affects treatment efficacy. “Without an accurate diagnosis, you don’t have the right treatment,” adds Black.
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Black also points out that most biomedical products tend to be developed and tested on Caucasians with genetic differences from Asians. “The reason for that is not [by design]; rather, most of the diagnostic tests and drugs we use or consume generally emanate out of the US.”
To address these issues, Inex works closely with companies to research, develop and share its practical nous on non-invasive and patient-friendly tests that aim to increase screening participation rates and improve patient outcomes. “We also see high accuracy rates in Asian patients for our tests because we use Asian patient samples to develop these tests,” adds Black.
One example is the company’s epiDx® product, which Black believes delivers “significant clinical value” by diagnosing breast cancer without requiring patients to undergo mammography. Around half of Asian women have dense breast tissue, which shows white under a mammogram, as does cancer tissue. In addition, the dense tissue makes for a more uncomfortable experience when it is compressed during screening, which can put patients off return visits. “What we see in Singapore is that women might go for a mammogram once but not go back for a second time if they felt their first experience was invasive and uncomfortable,” says Black.
Inex’s epiDx® is a patient-friendly option that reduces discomfort from standard imaging processes. By using a blood sample, it displays higher sensitivity and specificity than existing methods. “With a liquid biopsy-based test, which patients can have done at their general practitioners (GPs) when they visit for regular check-ups, they can also opt to have a simple blood draw which can determine whether a patient has breast cancer with a high degree of accuracy.”
He adds: “At Inex, we see every patient who interacts with our products as a singular being who deserves individual care and attention. Customer satisfaction is at the core of our vision and heart of our operations.”
Making societal breakthroughs
Black also believes that Inex’s uniquely science-backed foundation and entrepreneur-led strategy have helped the company develop into a critical innovation group for the life sciences industry for women in Asia and will continue to see the company make significant real-world contributions.
“As a company founded by practising clinicians, we believe we’re at the forefront of discovering unmet clinical needs. One of the issues that companies face in our sector is that inventors and scientists can often develop technologies which may not have clinical requirements or maybe create a solution to a problem that doesn’t exist.”
One example of a critical problem that Inex identified was the lacking accuracy in the existing “gold standard” for diagnostic testing of ovarian cancer, the CA-125 test. The test, which measures for the CA-125 protein in blood samples, was found by a long-term study in the UK only to have a 50% accuracy rate, which is no different than “flipping a coin”.
“Ovarian cancer is interesting because while it’s the seventh-most prevalent [form of cancer], it’s the most deadly. The reason is that it is often found at that very late stage,” says Black. “We saw early on that there was an unmet need for which we felt compelled to improve diagnosis and, therefore, also patient outcomes.”
To remedy this issue, Inex’s pipeline product XENA® will enable early detection of ovarian cancer through a non-invasive and cost-effective blood test, reducing the need for unnecessary invasive biopsies. The non-invasive liquid biopsy test based on cell-free MicroRNA biomarkers will improve malignant adnexal mass detection and has yielded a “very high accuracy” in its Phase One study with over 400 patients.
As a leader in the field of foetal cells isolation in maternal blood and one of only four experts globally focused on non-invasive prenatal diagnostics, Inex was the first company to introduce non-invasive prenatal testing in Singapore and the wider Southeast Asia region in what has today become a common form of testing for pregnant mothers.
“When we first launched non-invasive prenatal testing, that was quite revolutionary in Singapore. Today, around 50% of all births in Singapore will undergo these tests,” says Black, who notes that there is still “a way to go” in the market. The blood test that INEX first introduced detected the central trisomy disorders of Down syndrome, Edward syndrome and Patau syndrome, as well as 72 different microdeletion syndromes.
Next year, the company will make more significant progress in this field with the launch of its prenatal diagnostic technology, LEXI®, which will allow the analysis and identification of over 7,000 foetal genetic conditions. “The future of that will be applying therapy while the baby is unborn rather than once it is born. That will be quite a breakthrough for us and society,” says Black.
Singapore company with global ambitions
The company now has 49 patents in the women’s and maternal health area and 12 trademarks, as well as a range of copyrights, domain names and other intellectual property (IP) tied to its technologies. Black says IP is a critical part of Inex’s business as it protects its inventions generated through internal research and development (R&D), increasing the probability of these technologies becoming validated and reaching their target markets to provide patients with better treatment options. “It’s important to have this protection, as funding comes off the back of the IP tied to our various technologies. Without the funding for R&D, none of those technologies would ever see the light of day.”
“Our focus on democratising diagnostics, making it more available and affordable also comes with greater scale,” adds Black, who says the company is currently “eyeing up” several potential acquisition opportunities across Southeast Asia and North Asia. Inex also appoints distributors for its products, with three recently signed up in Europe, Vietnam and Malaysia.
Meanwhile, Inex’s head office in Singapore and iGene Laboratory, its College of American Pathologists (CAP) accredited laboratory in Science Park, will continue to sink their roots in the country as it grows internationally.
Although the company had intended its initial public offering (IPO) to happen this year, Black says that this move has been put on hold, considering the current “sub-optimal IPO environment”.
He adds that Inex had been leaning towards listing the company in Singapore, although it had considered other exchanges, including the Nasdaq and the Stock Exchange of Hong Kong. “We see that Singapore is making a lot of effort to target homegrown companies here at home. Ultimately, we are a Singaporean company and part of Singapore,” says Black. “I think it would be the right move for us to IPO on the Singapore Exchange S68 (SGX).”
“When the markets become more optimal, we’ll revisit the IPO. That is the plan, but we’ll have to wait and see how long the current head-
winds will go on,” he continues. “In the meantime, we are focused on launching our new technologies, expanding in the region and bulking up through acquisition.”
