Precision Biosensor

Precision Biosensor was founded in 2009 as TeraWave and grew into a global in-vitro diagnostics (IVD) company after incorporating US subsidiary Nano-Ditech in 2015, listing on KOSDAQ in December 2020 under the technology growth special listing track.

Its core business centers on manufacturing and selling point-of-care testing (POCT) analyzers and cartridges using time-resolved fluorescence (TRF) immunoassay and multiplex clinical chemistry platforms, detecting biomarkers for cardiovascular, infectious, inflammatory, and oncological conditions as well as HbA1c.

Key products include the Exdia TRF Plus and Exdia TRF immunoassay analyzers and the Exdia PT10 series of clinical chemistry analyzers, supplied to markets including Europe and Japan.

US subsidiary Nano-Ditech targets the North American market with COVID-19 and influenza diagnostic kits and has signed long-term supply agreements with partners including Sekisui.

In October 2024, Kwangdong Pharmaceutical pursued a stake acquisition that brought its holding to 54.73%, making it the largest shareholder, and in February 2026 the company absorbed fellow Kwangdong affiliate CT Bio, expanding its B2C lineup including compact glucose diagnostic products.

The company was established in 2009 as TeraWave, developing advanced optical analysis technology, and grew into a global in-vitro diagnostics company after incorporating US-based Nano-Ditech as a subsidiary in 2015.

Its core business is the development, manufacturing, and sale of in-vitro diagnostic devices and reagents, and it entered the clinical chemistry diagnostics field in 2021 using time-resolved fluorescence immunoassay technology to produce analyzers and cartridges.

Competitively, the global IVD market is dominated by large multinational players, positioning Precision Biosensor to compete on technology in niche POCT segments and specific biomarker categories.

In the CT Bio merger, approximately KRW 10.4 billion in consideration was paid to acquire KRW 2.3 billion in net assets, generating roughly KRW 8 billion in new goodwill.

Consolidated revenue in 2025 reached KRW 19.93 billion, up 4.1% from KRW 19.13 billion in 2024, though revenue has remained largely stagnant in a narrow band around KRW 20 billion over four years when compared to KRW 20.39 billion in 2023 and KRW 20.46 billion in 2022.

Operating loss stood at KRW 5.38 billion in 2025, nearly identical to KRW 5.37 billion in 2024, with operating margins of -27.0% and -28.0% respectively reflecting persistent structural losses.

Net loss attributable to owners widened to KRW 10.02 billion in 2025 from KRW 7.31 billion in 2024, a divergence from the operating loss trend that appears driven by non-operating factors such as convertible bond valuation losses rather than core operations.

On a quarterly basis, the loss narrowed from an operating loss of KRW 1.45 billion on revenue of KRW 4.90 billion in Q2 2025 to an operating loss of KRW 1.03 billion on revenue of KRW 5.12 billion in Q3, before widening again in Q4 with revenue of KRW 5.29 billion, an operating loss of KRW 1.40 billion, and a net loss attributable to owners of KRW 3.79 billion.

In Q1 2026, revenue jumped to KRW 7.03 billion, with the company posting its first quarterly operating profit of KRW 17.46 million and a net profit attributable to owners of KRW 133 million.

However, Q2 2026 saw revenue decline to KRW 6.22 billion with the company reverting to an operating loss of KRW 1.21 billion and a net loss attributable to owners of KRW 1.17 billion, leaving open the question of whether the Q1 profit was a one-off event or the start of a trend that will require further quarters to confirm.

On the cash flow side, operating cash flow was negative every year from 2022 through 2025 (KRW -2.58 billion, -1.95 billion, -1.44 billion, and -1.51 billion respectively), though the magnitude of the shortfall has shown a moderating trend.

The in-vitro diagnostics (IVD) market, spanning both large hospital-grade equipment and point-of-care testing (POCT), is viewed as a continually growing segment as automated, miniaturized devices improve in accuracy.

Point-of-care in-vitro diagnostic devices are used for rapid diagnosis in emergency settings and small to mid-sized hospitals, with the market growing as automated and miniaturized devices improve in accuracy.

In Korea, according to the Korean Diabetes Association, approximately 6 million adults aged 30 and over have diabetes, with roughly approximately 6 million people have diabetes.

The prediabetic population also reaches approximately 16 million, and demand for glucose management testing is expected to continue increasing. This forms the potential demand base for the HbA1c diagnostics market that Precision Biosensor is newly entering.

Competitively, large global IVD companies such as Roche Diagnostics, Siemens, and Abbott hold top market shares, meaning smaller players like Precision Biosensor must compete through technological differentiation in specific biomarker or emergency medicine niche markets.

The domestic diagnostic kit sector overall is moving past the post-COVID-19 demand normalization phase, with individual companies now differentiated by the pace of new product certifications and overseas channel expansion.

In animal diagnostics, the company is diversifying through supply agreements amid growth in the pet care market, while industry consolidation trends are also being observed, including a global pet food company acquiring an animal diagnostics firm.

Precision Biosensor stated it plans to apply for European Institutional Review Board (IRB) approval for its HbA1c diagnostic product Exdia HbA1c in the second half of 2026 and pursue local clinical trials and European In Vitro Diagnostic Regulation (IVDR) certification in 2027 to begin full-scale global sales.

Domestically, the company has already obtained manufacturing certification, expanding its immunoassay portfolio into glucose management following cardiovascular, infectious disease, and hormone diagnostics, while building its sales base through expanded domestic distributor agreements since last year.

US subsidiary Nano-Ditech received full FDA approval for its influenza rapid diagnostic kit, rounding out a three-product respiratory diagnostics portfolio alongside its existing COVID-19/influenza combo product to accelerate its US market push.

The company expects the B2C diagnostic product lineup gained through the CT Bio merger to contribute to future revenue growth and profitability improvement, and Kwangdong Pharmaceutical has stated in disclosures its intent to develop diagnostics as a new growth driver at the group level.

The company reportedly renewed a supply contract with a Romanian client in Europe by adding clinical chemistry products through 2026, with the contract scale reportedly expanded from previous levels.

However, the timing for these new product certifications and expanded overseas contracts to translate into actual revenue growth and a sustained return to profitability has not yet become clear, as illustrated by the temporary Q1 2026 profit followed by a reversion to loss in Q2, underscoring significant quarter-to-quarter volatility.