- 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
- 早期檢測前列腺癌的10分鐘家庭PSA測試
- 第一筆訂單已經發往沙特阿拉伯
- 前列腺癌是全球男性第二常見的癌症
美國愛文思控股公司（納斯達克：BMRA）很高興宣佈，沙特食品和藥品管理局（SFDA）已批准該公司的Fortel前列腺（PSA）篩查試劑在該國銷售和使用。該檢測試劑可以在家中進行，有助於男性及時發現前列腺癌的早期預警信號。
Fortel前列腺(PSA)家庭自測檢測是一種用戶友好、快速的診斷工具，可測量升高的PSA，這是前列腺疾病(包括癌症)的早期指標。該檢測利用簡單的手指採血樣本，在短短10分鐘內提供高度準確的結果，使其成爲對抗前列腺癌的一項易於獲得且必不可少的工具。
中東的戰略拓展
該批准標誌着Biomerica在中東的戰略擴張邁出了重要一步，該地區的前列腺癌日益被視爲公共健康關切的里程碑。Biomerica致力於讓早期檢測更易獲得，並與領先分銷商建立了合作伙伴關係，獲得了關鍵的監管批准，並從迪拜政府獲得了EZ Detect結腸疾病家庭自測檢測的保險報銷。公司目前正在努力在該地區複製Fortel PSA檢測的成功。
經過驗證的性能
Fortel PSA測試表現出色。一項研究顯示，與實驗室參考方法相比，該測試的敏感度爲100％，特異度爲95％，準確度爲97.5％。此外，埃及阿因謝姆斯大學醫學院的一項研究證實了該測試的強大性能，敏感度爲97.2％，特異度爲96.2％，準確度爲96.7％。
全球和區域型影響
全球範圍內，2020年確診了約140萬例前列腺癌，導致37.5萬人死亡。前列腺癌是男性中第二最常見的癌症，每兩分鐘就有一個新病例。過去十年間，前列腺癌在中東地區已逐漸被認識爲一項重要的公共衛生挑戰。該病在不同地區、年齡組、種族和人種中的患病率和嚴重程度各不相同。雖然在歐洲和北美對前列腺癌進行了大量研究，但中東地區的綜合研究仍存在空白。
展望未來
biomerica已將Fortel PSA篩查測試的首批訂單發運給其在沙特阿拉伯的分銷商。該公司致力於擴展其在該地區的業務，爲早期癌症檢測的迫切需求提供創新、易於獲取的診斷解決方案。
（訪問時間：2024年8月5日）
（訪問時間：2024年8月5日）
Mutlay Sayan等人的研究：《中東地區的前列腺癌意識：一項橫斷面國際研究》。JCO全球腫瘤學10，e2400171（2024年）.
關於 Biomerica（納斯達克股票代碼：BMRA）
Biomerica, Inc.是一家全球性生物醫學技術公司，致力於開發、申請專利、製造和銷售先進的診斷和治療產品，這些產品可在護理點（家庭和醫生辦公室）以及醫院/臨床實驗室使用，用於檢測和/或治療醫療狀況和疾病。公司的產品旨在提高人們的健康和福祉，同時降低醫療保健總成本。Biomerica 主要關注胃腸道和炎症性疾病，公司有多種診斷和治療產品正在開發中。
來源：biomerica
