Trinity Biotech Shares Soar 89% on NYSDOH Approval Trading Volume Surges 6351055% to Rank 200th in Market Activity

Trinity Biotech (NASDAQ: TRIB) surged 89.05% on August 14, 2025, with a trading volume of $0.5 billion, marking a 63,510.55% increase from the previous day. The stock ranked 200th in market activity. This sharp rise followed regulatory approval from the New York State Department of Health (NYSDOH) to launch its FDA-cleared PreClara™ Ratio biomarker test for preeclampsia risk assessment in Q3 2025. The test, which measures sFlt-1/PlGF ratios, addresses a critical unmet need in maternal health by enabling early detection of severe preeclampsia progression in hospitalized patients with hypertensive pregnancy disorders.

The approval unlocks a significant commercial opportunity for Trinity, given that approximately 500,000 U.S. women annually face hypertensive pregnancy disorders. Clinical studies suggest the test could reduce preterm deliveries and NICU admissions, generating neonatal cost savings exceeding $10 million per 1,000 patients. This development also lays the groundwork for the future launch of PrePsia™, Trinity’s early pregnancy risk assessment technology, expanding its footprint in maternal diagnostics. The regulatory milestone strengthens the company’s position in the U.S. diagnostics market and aligns with its broader strategy to diversify revenue streams through innovative women’s health solutions.

Analysts note that the NYSDOH clearance demonstrates Trinity’s ability to navigate complex regulatory landscapes, a key factor in scaling its diagnostic offerings. The PreClara™ test’s potential to reduce healthcare costs while improving patient outcomes positions it as a strategic asset in a high-growth segment. With the third-quarter rollout planned, the company is expected to leverage this approval to accelerate market adoption and drive long-term value creation.

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