Hong Kong – South Korea’s Lunit Inc. is currently in the process of applying for U.S. FDA approval for Lunit Insight Mmg, its AI software that analyzes mammography images to detect breast cancer. Other markets that the company targets entering include South America, the Middle East, and Asia Pacific, Jussarang Lee, communications manager at Lunit, told BioWorld. Founded in 2013, the Seoul-based company uses artificial intelligence to develop cancer diagnostics and therapeutics.

The European Commission (EC) gave its approval to the software on May 26, enabling its sale and usage throughout the European Union as well as the European Free Trade Association. The European market will benefit from the software, as the continent’s guidelines “recommend double-reading of mammography and other screening examinations, which leads to extensive interpretation processes that require more time and resources. In such a screening environment, Lunit Insight Mmg can be of assistance in double-reading, as it detects breast cancer with 97% accuracy within seconds. Lunit Insight Mmg is expected to relieve the pressure of double-reading while increasing interpretation accuracy of mammography images,” Lee explained.

“Among the patients [who are suspected to have] breast cancer [after a mammography screening], only 29% [are] actually diagnosed with cancer after a biopsy. I am delighted to introduce Lunit Insight Mmg, now CE certified, to health care professionals and institutions across the European continent. With our AI software, we would like to increase the effectiveness of mammography screening and reduce unnecessary biopsies,” Brandon Suh, CEO of Lunit, said. Lunit opened a European branch office in Amsterdam in May around the time of the approval. The office will lead efforts in the region via its team of salespeople, engineers, and other local hires.

Lee added that the EC approval, which had been expected at the end of 2019, experienced delays. But she added that there was “no information” to support blaming the delay on the COVID-19 virus, with cases only just starting to be reported in Wuhan around that time. Lunit is hoping to receive FDA approval later in the year but Lee expects that this process could potentially be delayed as well.

Closer to home, South Korea’s Ministry of Food and Drug Safety (MDFS) approved the software for use in South Korea almost a year ahead of the EC in July 2019. MFDS had granted initial approval in August 2018.

Lunit Insight Mmg works by analyzing digital mammography images, using AI technology to identify malignant lesions and locating them on the images. An “abnormality score” is generated, which indicates the probability of breast cancer in the patient.

One of the biggest challenges in mammography interpretation is breast density, and the software has incorporated a high level of sensitivity to detect the cancer in dense breast tissues, according to a study published in Lancet Digital Health.

The study validated Lunit Insight Mmg’s performance against a dataset of more than 36,000 cancer positive cases that were also confirmed via biopsies. It showed that AI, in comparison to a radiologist reader group, detected cancer with mass better, with AI detecting 90% of the cases and the radiologists 78%. The difference was more pronounced for distortion or asymmetry, with AI detecting 90% vs. the radiologists’ 50%.

Meanwhile, Lunit is keeping busy with an active pipeline. It is currently developing an AI solution for digital breast tomosyntheis (DBT) as well as one for chest CTs, as well as continuing its research and development in the pathology and oncology fields.

Also under development is Lunit Scope, which analyses digitized tissue slide images. The analyzed images help to predict patient response to immunotherapy and are a potential AI biomarker. The company is now testing the validity of the approach as well as Lunit Scope’s role in it.

The company raised KRW 30 billion (US$24.62 million) in series C funding at the beginning of the year, and is preparing a series D funding, which targets raising $25 million at the end of 2020. The company is looking to tap foreign strategic investors such as medical device producers along with insurance and pharmaceutical companies in the latest round.

Participants in the last round of funding include Legend Capital Co. Ltd., Intervest Co. Ltd., Imm Investment Corp., Kakao Ventures Corp., Shinhan Investment Corp., Nh Investment & Securities Co. Ltd., Lg Cns. Co. Ltd. Lunit’s other investors include Fujifilm and Softbank.

The series D funding, once completed, could increase Lunit’s war chest to $75 million from the current $50 million.

Although Lunit did not disclose how the series D funding would be used, the series C funding was used to expand the global reach of its products such as Lunit Insight Cxr, which analyzes chest X-rays, and Lunit Insight Mmg.