'COVID-19 outbreak to shed new light on lab-free diagnostics'

Noul co-founder and CEO David Lim poses during an interview with The Korea Times at the company's headquarters in Yongin, Gyeonggi Province, March 18. Korea Times photo by Choi Won-suk

Noul seeks to win WHO validation on malaria diagnosis device next year

By Nam Hyun-woo

YONGIN, Gyeonggi Province ― With the global COVID-19 outbreak, the field of diagnostics is garnering unprecedented attention, as countries struggle to keep up with the fast spread of the deadly virus.

David Lim, co-founder and CEO of blood cell diagnostics firm Noul, says this highlights the importance of decentralization in diagnostics, which can help the world to detect diseases faster and prevent epidemics more effectively.

"Every blood cell diagnosis is bound to be centralized at large labs because of facilities, infrastructure and workforces. This results in a long period of time in testing and raises the risks of an infected sample shutting down the whole lab, because it can contaminate thousands of other samples that come into the lab," Lim said during an interview with The Korea Times.

"Along with COVID-19, the world is expected to face more contagious diseases in the future, and many of them could become chronic and last for years. Under the current centralized diagnostics infrastructure, the role of local clinics will be seriously limited. This triggers the necessity for a decentralized diagnostics platform, on which local clinics and even medically underdeveloped areas can diagnose malaria, cancer and other serious diseases."

Noul was established in 2015 as a startup developing artificial intelligence-based diagnostics devices. Its core product is the miLab diagnosis device and test cartridge, which enables fully automated testing.

Conventional blood cell diagnostics requires processing of collecting venous blood, smearing and staining and microscopy analysis. These processes are mostly done manually by experienced technicians, thus taking anywhere from one to 66 days for results and requiring large labs, a significant workforce and facilities for water waste.

According to the company, it combined the whole process of blood cell diagnostics into the device ― which is the size of a small conveyor toaster ― and can produce test results in 15 minutes.

Instead of the conventional labor-intensive sample preparation, miLab tests blood with cartridges, which uses solid chemicals instead of liquid reagents for staining. With a few drops of finger-pricked blood in the cartridge, miLab automatically does the smearing, staining, digital microscopic imaging, and AI analytics. By using different cartridges, the device can diagnose various other oncology diseases including breast and thyroid cancers.

Since it is equipped with a 3G or LTE communications module and even runs on a battery, the device is useful in rural settings for containing the outbreaks of communicable diseases, Lim said.

Noul's miLab diagnosis device / Courtesy of Noul

"This is somewhat similar to the concept of blockchain, whose core idea is decentralization," Lim said. "We believe miLab can improve the diagnostics system in Korea, where all patients flock to large hospitals for diagnosis, forcing serious or emergency patients to wait. Since miLab does not require space, liquid reagents, water or diagnostics specialists, it will help smaller clinics to diagnose serious diseases and large hospitals to save costs."

Currently, miLab's prime target is malaria, a disease that requires more than 500 million tests to be carried out each year. There are portable devices for malaria screening, but there is no portable device that can make a confirmed diagnosis, Lim said, casting a rosy outlook on the market potential. Screening tests help evaluate the risks of conditions which could turn into a certain disease, while diagnosis tests confirm the presence of the disease.

"Though the public attention is on COVID-19, malaria remains a deadly disease, killing more than 400,000 people a year, and there are so many diseases like malaria," Lim said.

Noul's effort in fighting malaria has been recognized internationally.

In December last year, the company won the People's Choice Award at the 2019 Grand Challenges meeting, co-hosted by the Bill & Melinda Gates Foundation, for miLab's potential in malaria diagnosis in Africa, where has underdeveloped medical infrastructure.

Currently, the company is seeking to win WHO Prequalification on miLab in the third quarter of next year, which means the device has unified standards of quality, safety and efficacy assessed by the organization. Given the WHO uses approximately 4 trillion won a year to battle against malaria, miLab's winning of the prequalification raises the chances of the WHO purchasing the device in large quantities, according to Lim.

Noul is also applying for the validation process of the Foundation for Innovative New Diagnostics (FIND), which is a Geneva-based organization collaborating with the WHO in the development of urgently needed diagnostic tests. Industry officials said a FIND validation will increase the chance of the WHO granting a waiver on its own validation before awarding prequalification.

"Currently, we don't think there is a rival," Lim said. "Malaria costs a significant portion of GDP in Africa and the world has a huge demand for malaria diagnosis devices, but not many firms were interested in this while we are looking at a huge market."

MiLab was approved by the Ministry of Food and Drug Safety and CE marked for the European market last year. Lim said Noul plans to get the CE In-Vitro Diagnostics mark and U.S. Food and Drug Administration approval this year.

Noul co-founder and CEO David Lim poses with the company's AI-powered automated diagnosis device miLab during an interview with The Korea Times at the company's headquarters in Yongin, Gyeonggi Province, March 18. Courtesy of Noul

Expansion of decentralized diagnosis

Since miLab is scalable to oncology diseases, Lim said the device will play a pivotal role in increasing healthcare accessibility, as well as fetching the company significant revenues.

"Currently we are working on cartridges for 15 diseases, and they will be available starting this year," Lim said. "About 70 percent of all medical decisions are based on a clinical laboratory test, and our goal is increasing our coverage as much as possible."

Noul seeks to roll out malaria and blood cell morphology cartridges in the first half this year; anemia and blood cancer cartridges in the first half of 2021; and other cancer cartridges in the second half of that year.

With the roadmap, Noul plans to attend the 2020 Bio International Convention in San Diego in June and will seek for investors and partner companies there before the anticipated FDA approval later this year.

For miLab's commercial launch, Noul will complete its plant in May, which can produce up to 5 million cartridges a year and 1,000 to 2,000 miLabs during the same period.

"We expect tangible revenues from the second half of this year, and are anticipating a high growth rate between 100 and 200 percent in the first place," Lim said. "Initially, we also had doubts about the marketability of miLab. As we move forward, however, we found unexpectedly high demand and now we are seeing a future in which decentralized diagnosis platforms are replacing large labs."

He said the company is planning to launch its initial public offering on the tech-heavy Kosdaq market next year.