- 10-Minute At-Home PSA Test for Early Detection of Prostate Cancer
- First order already shipped to Saudi Arabia
- Prostate Cancer is the Second Most Common Cancer in Men Globally
IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) is pleased to announce that the Saudi Food and Drug Authority (SFDA) has approved the Company's Fortel Prostate (PSA) Screening Test to be sold and used in the country. This at-home test is designed to empower men with the ability to detect early warning signs of prostate cancer from the comfort of their own homes.
The Fortel Prostate (PSA) At-Home Screening Test is a user-friendly, rapid diagnostic tool that measures elevated PSA, an early indicator of prostate disease, including cancer. Utilizing a simple finger-prick blood sample, the test delivers highly accurate results within just 10 minutes, making it an accessible and essential tool in the fight against prostate cancer.
Strategic Expansion in the Middle East
This approval marks a milestone in Biomerica's strategic expansion into the Middle East, a region where prostate cancer is increasingly recognized as a public health concern. Biomerica is dedicated to making early detection more accessible and has established partnerships with leading distributors, secured key regulatory approvals, and achieved insurance reimbursement from the Dubai government for its EZ Detect Colon Disease at-home Screening Test. The company is now working to replicate this success with the Fortel PSA test across the region.
Proven Performance
The Fortel PSA test has demonstrated exceptional performance. A study reported 100% sensitivity, 95% specificity, and 97.5% accuracy compared to laboratory reference methods. Additionally, a study conducted at the Faculty of Medicine in Ain Shams University, Egypt, confirmed the test's robust performance with 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy.
Global and Regional Impact
Globally, approximately 1.4 million new cases of prostate cancer were diagnosed in 2020, resulting in 375,000 deaths1. Prostate cancer is the second most common cancer among men worldwide, with one new case every two minutes2. Over the past decade, prostate cancer has become increasingly recognized as a significant public health challenge in the Middle East. The disease varies in prevalence and severity across different regions, age groups, ethnicities, and races. While extensive research on prostate cancer has been conducted in Europe and North America, there remains a gap in comprehensive studies within the Middle East.3
Looking Ahead
Biomerica has shipped the first order of the Fortel PSA Screening Tests to its distributors in Saudi Arabia. The company remains committed to expanding its footprint in the region, offering innovative, accessible diagnostic solutions that address the urgent need for early cancer detection.
(accessed 05 Aug 2024)
(accessed 05 Aug 2024)
Mutlay Sayan et al. Prostate Cancer Awareness in the Middle East: A Cross-Sectional International Study. JCO Glob Oncol 10, e2400171(2024).
About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.
Source: Biomerica
- 早期检测前列腺癌的10分钟家庭PSA测试
- 第一笔订单已经发往沙特阿拉伯
- 前列腺癌是全球男性第二常见的癌症
美国爱文思控股公司（纳斯达克：BMRA）很高兴宣布，沙特食品和药品管理局（SFDA）已批准该公司的Fortel前列腺（PSA）筛查试剂在该国销售和使用。该检测试剂可以在家中进行，有助于男性及时发现前列腺癌的早期预警信号。
Fortel前列腺(PSA)家庭自测检测是一种用户友好、快速的诊断工具，可测量升高的PSA，这是前列腺疾病(包括癌症)的早期指标。该检测利用简单的手指采血样本，在短短10分钟内提供高度准确的结果，使其成为对抗前列腺癌的一项易于获得且必不可少的工具。
中东的战略拓展
该批准标志着Biomerica在中东的战略扩张迈出了重要一步，该地区的前列腺癌日益被视为公共健康关切的里程碑。Biomerica致力于让早期检测更易获得，并与领先分销商建立了合作伙伴关系，获得了关键的监管批准，并从迪拜政府获得了EZ Detect结肠疾病家庭自测检测的保险报销。公司目前正在努力在该地区复制Fortel PSA检测的成功。
经过验证的性能
Fortel PSA测试表现出色。一项研究显示，与实验室参考方法相比，该测试的敏感度为100％，特异度为95％，准确度为97.5％。此外，埃及阿因谢姆斯大学医学院的一项研究证实了该测试的强大性能，敏感度为97.2％，特异度为96.2％，准确度为96.7％。
全球和区域型影响
全球范围内，2020年确诊了约140万例前列腺癌，导致37.5万人死亡。前列腺癌是男性中第二最常见的癌症，每两分钟就有一个新病例。过去十年间，前列腺癌在中东地区已逐渐被认识为一项重要的公共卫生挑战。该病在不同地区、年龄组、种族和人种中的患病率和严重程度各不相同。虽然在欧洲和北美对前列腺癌进行了大量研究，但中东地区的综合研究仍存在空白。
展望未来
biomerica已将Fortel PSA筛查测试的首批订单发运给其在沙特阿拉伯的分销商。该公司致力于扩展其在该地区的业务，为早期癌症检测的迫切需求提供创新、易于获取的诊断解决方案。
（访问时间：2024年8月5日）
（访问时间：2024年8月5日）
Mutlay Sayan等人的研究：《中东地区的前列腺癌意识：一项横断面国际研究》。JCO全球肿瘤学10，e2400171（2024年）.
关于 Biomerica（纳斯达克股票代码：BMRA）
Biomerica, Inc.是一家全球性生物医学技术公司，致力于开发、申请专利、制造和销售先进的诊断和治疗产品，这些产品可在护理点（家庭和医生办公室）以及医院/临床实验室使用，用于检测和/或治疗医疗状况和疾病。公司的产品旨在提高人们的健康和福祉，同时降低医疗保健总成本。Biomerica 主要关注胃肠道和炎症性疾病，公司有多种诊断和治疗产品正在开发中。
来源：biomerica
