Laguna Diagnostics是一家总部位于加州的生物技术公司，专门从事基于血液的精神疾病检测。该公司已获得其第二项美国专利，该专利涉及能够快速区分精神分裂症和双相情感障碍的创新生物标志物。该专利涵盖了分析血液样本中基因表达的方法，有望解决精神卫生保健中的一个关键难题，因为误诊普遍存在，而准确治疗的延迟可能长达数年。在精准精神病学对客观工具的需求日益增长的背景下，这一发展使该公司在价值约30亿美元的年增长诊断市场中占据了有利地位，该市场涉及精神分裂症和双相情感障碍的管理。
专利及其技术基础
新授予的专利概述了一种诊断方法，该方法检测患者血液中18个特定基因的信使RNA（mRNA）表达水平。该过程包括多步分析：识别生物标志物模式，计算疾病存在的概率，并根据预定义的阈值对样本进行分类，将患者归类为患有精神分裂症（SZ）、双相情感障碍（BD）或神经系统正常（NC）。验证研究中的性能指标显示出高可靠性，区分这些疾病的诊断准确率超过90％，远远超过传统的客观评估。
这建立在Laguna公司2023年的基础专利以及2018年发表在《分子神经精神病学》杂志上的一项同行评审研究之上，该研究通过对90名参与者（来自三个组别）的血液进行外显子微阵列分析，首次确定了这些基因组。该技术将诊断从长期的临床观察（通常持续一到三年）转变为可在几天内获得结果，从而有可能减轻未经治疗或治疗不当的精神病所带来的社会经济负担，包括更高的自杀风险和认知能力下降。
在高风险领域应对误诊
精神分裂症影响约1％的美国人，而双相情感障碍影响高达2.8％的人群，数百万人经历着重叠的症状，如幻觉和情绪不稳定，这使得区分变得复杂。研究表明，精神分裂症的误诊率高达50％，双相情感障碍的误诊率高达70％，常常被错误地诊断为重度抑郁症或其他疾病。在一项对门诊环境的分析中，超过76％的双相情感障碍病例最初被误诊，通常是抑郁症（占错误诊断的70％）或精神分裂症（占20％）。种族差异加剧了这种情况：黑人和西班牙裔患者被诊断为精神分裂症的比例是白人的两到三倍，这可能归因于对症状解释的偏见。
Laguna’s tests aim to mitigate these issues by providing objective, biomarker-driven insights, enabling earlier interventions that could improve outcomes and cut healthcare costs associated with prolonged uncertainty. Independent research supports the need: A 2021 GenomeWeb report highlighted the 18-gene panel’s 83-88 percent accuracy in initial trials, with potential for even higher precision in unmedicated or younger patients, though further replication in diverse cohorts is ongoing.
Company Momentum and Broader Market Context
Founded by psychiatric genomics expert Marquis P. Vawter and life sciences veteran Terry W. Osborn, Laguna has secured National Institute of Mental Health grants and collaborates with institutions like the University of California-Irvine and University of Iowa. The firm is now pursuing seed funding to validate lab-developed tests under CAP/CLIA standards and launch FDA clinical trials, signaling readiness for commercialization.
The innovation arrives as the global mental health diagnostics sector expands rapidly, projected to reach $623 billion by 2032, driven by increasing prevalence—37 million people worldwide live with bipolar disorder alone—and advancements in AI-assisted tools. Antipsychotic markets, closely tied to accurate SZ/BD diagnosis, are forecasted to grow from $19.45 billion in 2024 to $41.21 billion by 2034. In the U.S., behavioral health spending is set to hit $151.62 billion by 2034, fueled by telehealth and stigma reduction efforts.
Implications for Psychiatry and Patient Care
This patent not only fortifies Laguna’s intellectual property but also underscores a paradigm shift toward biomarker-led psychiatry, where tests like these could prevent the 39 percent overall misdiagnosis rate seen in severe psychiatric cases. By enabling precise early detection, the technology holds promise for tailored therapies, reduced trial-and-error with medications, and better equity in care, particularly for underserved populations. As validation advances, Laguna’s approach could redefine standards, offering clinicians reliable data to guide decisions in a field long reliant on observation. For more details, visit the company’s platform or contact its leadership.
