[Edaily Reporter YU JIN-HEE ] “Building on our designation as an innovative medical device by the U.S. Food and Drug Administration (FDA), we plan to establish a local subsidiary within this year. Next year, we will launch laboratory-developed tests (LDTs) and accelerate our diagnostic kit business to significantly boost local sales. Once we are firmly established in the U.S. market, we expect to achieve annual sales of approximately 30 billion won from this business alone.”

Kang Seong-min, CEO of PeopleBio, Inc.(304840), expressed strong confidence in the company’s U.S. market strategy during a recent interview with E-Daily at the company’s headquarters in Bundang-gu, Seongnam, Gyeonggi Province.

Building on the FDA’s Breakthrough Device Designation (BDD) for “AlzOn Plus,” a blood test kit for the early diagnosis of Alzheimer’s disease, PeopleBio, Inc. is taking concrete steps to enter the world’s largest healthcare market.

Clears FDA Innovative Medical Device Gateway… Shortens Approval Process via BDD and TAP Two-Track Approach

AlzOn Plus, developed by PeopleBio, Inc., is a product that precisely measures the aggregation level of misfolded amyloid-beta proteins present in extremely small amounts in the blood. It was developed based on the company’s proprietary technology, the Misfolded Protein Disease Diagnostic System (MDS). Recognized for its innovation in detecting early warning signs of disease risk before symptoms appear, it was recently officially designated as an Innovative Medical Device by the FDA. Among domestic blood-based diagnostic kit companies, PeopleBio, Inc. is the second ever to clear the FDA’s Innovative Medical Device designation, following Genomictree Inc.(228760), which holds the EarlyTec for early colorectal cancer diagnosis.

CEO Kang explained, “All three global companies that have currently obtained formal FDA product approval—Fujirebio, C2N, and Roche—have demonstrated the innovation and potential of their technologies by passing through the BDD process,” adding, “BDD designation is the surest gateway to increasing the probability of obtaining the FDA’s rigorous final approval.”

PeopleBio, Inc. is currently expediting its entry into the FDA’s Targeted Action Pathway (TAP) program. The company has also implemented strategies to shorten the formal approval process through close consultation with a contract research organization (CRO).

CEO Kang stated, “New biomarkers, such as AlzOn Plus, typically take more than three years to complete U.S. clinical trials and obtain approval,” adding, “We will actively utilize dedicated FDA support to bring forward the date of full approval as much as possible.”

PeopleBio, Inc. is prioritizing the U.S. Laboratory-Developed Test (LDT) market, separate from the formal marketing authorization process, which requires long-term clinical trials. The U.S. LDT market is estimated to be worth $6.61 billion (approximately 9 trillion won) this year. It is projected to grow at an average annual rate of 6.69% and reach $11.84 billion (approximately 16 trillion won) by 2035.

LDTs allow for immediate testing services based on a physician’s order, following in-house validation within a standard laboratory certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA). This business model enables early revenue generation even before product approval.

CEO Kang stated, “We are approaching the supply of LDTs and finished diagnostic kits not as separate entities but as a single, integrated business structure,” adding, “We are currently in close discussions with leading CLIA labs regarding specific collaboration frameworks.”

He continued, “We plan to successfully complete the establishment of a local U.S. subsidiary within this year and begin generating revenue immediately starting next year,” adding, “We are also moving swiftly to obtain a medical procedure billing code from the American Medical Association (AMA).”

Explosive Demand for Early Screening… Entering the 14 Trillion Won Alzheimer’s Diagnosis Market

The market environment is also becoming more favorable for PeopleBio, Inc. According to industry sources, the global market for Alzheimer’s diagnosis and early screening this year is estimated to range from approximately $10.4 billion (about 14 trillion won) to $11 billion (about 15 trillion won). Driven by the expanding availability of antibody therapies and an aging population, the market is projected to grow to between $26 billion and $27.9 billion (approximately 35 trillion to 37 trillion won) by 2035. The compound annual growth rate (CAGR) is expected to reach 10.8%. With the commercialization of new antibody drugs—such as lecanemab and donanemab—that remove amyloid deposits in the brain, early diagnosis during the initial mild cognitive impairment (MCI) stage has become the key to treatment success. CEO Kang plans to gradually pursue integration with the U.S. public health insurance program, Medicare, to maximize incentives for local healthcare providers to prescribe the treatment.

“Existing positron emission tomography (PET) scans and cerebrospinal fluid (CSF) tests are limited by their high cost and the invasive nature of the sample collection,” he explained. “In contrast, PeopleBio, Inc.’s blood test is simple to perform with a single blood draw, making it ideal for repeated testing and treatment monitoring.”

PeopleBio, Inc. is also accelerating efforts to secure internal financial stability and improve profitability. In the second quarter, consolidated revenue surged 128% year-over-year to 1.67 billion won. During the same period, the operating loss was significantly reduced by more than half to 680 million won, demonstrating a clear recovery in performance. Cumulative revenue for the first half of the year reached 2.3 billion won, a 53% increase compared to the same period last year.

These figures confirm the success of the company’s efforts to lower its cost-to-sales ratio through rigorous organizational restructuring and cost-cutting measures. The company maintained continuity in the development of its core pipeline while controlling fixed costs through open collaboration with external research institutions, such as Gachon University.

CEO Kang emphasized, “We have overcome the operational setbacks and external variables we faced since our IPO to establish a solid foundation for self-reliance,” adding, “We will prove the value of our core biotech innovations to our shareholders by simultaneously achieving the commercialization of our LDT in the U.S. and the global export of our technology.”