United Arab Emirates Ministry of Health and Prevention Approves Biomerica’s Fortel® PSA Screening Test to Detect an Early Sign of Prostate Cancer
Biomerica (NASDAQ: BMRA) has received approval from the United Arab Emirates Ministry of Health and Prevention for its Fortel® PSA Screening Test, a 10-minute diagnostic tool for detecting prostate cancer markers through finger-prick blood samples. The test has demonstrated impressive clinical performance with 100% sensitivity, 95% specificity, and 97.5% accuracy in studies.
This approval marks a strategic expansion in the Middle East market, where Biomerica already has success with its EZ Detect Colon Disease Test. The Fortel® PSA test aims to address the growing concern of prostate cancer, which is the second most common cancer in men globally with 1.4 million new cases and 375,000 deaths reported in 2020.
The company is working with regional distributors to make early cancer detection more accessible, building on their previous achievement of securing government insurance reimbursement in Dubai for their colon screening test.
Biomerica (NASDAQ: BMRA) ha ricevuto l'approvazione dal Ministero della Salute e della Prevenzione degli Emirati Arabi Uniti per il suo Fortel® PSA Screening Test, uno strumento diagnostico di 10 minuti per la rilevazione dei marcatori del cancro alla prostata attraverso campioni di sangue prelevati con una puntura sul dito. Il test ha dimostrato un'impressionante performance clinica con il 100% di sensibilità, il 95% di specificità e il 97,5% di accuratezza negli studi.
Questa approvazione segna un'espansione strategica nel mercato del Medio Oriente, dove Biomerica ha già ottenuto successo con il suo test EZ Detect Colon Disease. Il test Fortel® PSA mira a rispondere alla crescente preoccupazione per il cancro alla prostata, che è il secondo tipo di cancro più comune tra gli uomini a livello globale, con 1,4 milioni di nuovi casi e 375.000 decessi riportati nel 2020.
La compagnia sta collaborando con distributori regionali per rendere più accessibile la rilevazione precoce del cancro, basandosi sul loro precedente successo di ottenere il rimborso assicurativo governativo a Dubai per il loro test di screening del colon.
Biomerica (NASDAQ: BMRA) ha recibido la aprobación del Ministerio de Salud y Prevención de los Emiratos Árabes Unidos para su Fortel® PSA Screening Test, una herramienta diagnóstica de 10 minutos para detectar marcadores de cáncer de próstata a través de muestras de sangre obtenidas con una punción en el dedo. La prueba ha demostrado un rendimiento clínico impresionante con 100% de sensibilidad, 95% de especificidad y 97.5% de precisión en los estudios.
Esta aprobación marca una expansión estratégica en el mercado de Oriente Medio, donde Biomerica ya tiene éxito con su prueba EZ Detect Colon Disease. La prueba Fortel® PSA tiene como objetivo abordar la creciente preocupación por el cáncer de próstata, que es el segundo tipo de cáncer más común en los hombres a nivel mundial, con 1.4 millones de nuevos casos y 375,000 muertes reportadas en 2020.
La compañía está trabajando con distribuidores regionales para hacer más accesible la detección temprana del cáncer, construyendo sobre su logro previo de asegurar el reembolso de seguros gubernamentales en Dubái para su prueba de detección de colon.
Biomerica (NASDAQ: BMRA)는 아랍에미리트 보건부로부터 Fortel® PSA Screening Test에 대한 승인을 받았습니다. 이 10분 진단 도구는 손가락을 찔러 혈액 샘플을 통해 전립선 암 표지를 감지합니다. 이 테스트는 연구에서 100%의 민감도, 95%의 특이도 및 97.5%의 정확성을 포함한 인상적인 임상 성능을 보여주었습니다.
이번 승인은 중동 시장에서의 전략적 확장을 의미하며, Biomerica는 이미 EZ Detect 대장 질환 테스트로 성공을 거두었습니다. Fortel® PSA 테스트는 전 세계적으로 남성들 중 두 번째로 흔한 암인 전립선 암에 대한 증가하는 우려를 해결하기 위한 것입니다. 2020년에 보고된 새로운 전립선 암 사례는 140만 건, 사망자는 37만 5천 명입니다.
회사는 조기 암 검출을 보다 손쉽게 접근할 수 있도록 지역 유통업체와 협력하고 있으며, 이는 두바이에서 대장 검진 테스트에 대한 정부 보험 환급을 확보한 이전 성과를 기반으로 하고 있습니다.
Biomerica (NASDAQ: BMRA) a reçu l'approbation du ministère de la Santé et de la Prévention des Émirats Arabes Unis pour son Fortel® PSA Screening Test, un outil de diagnostic de 10 minutes pour détecter les marqueurs du cancer de la prostate à partir d'échantillons de sang prélevés par un piqûre au doigt. Le test a montré des performances cliniques impressionnantes avec une sensibilité de 100 %, une spécificité de 95 % et une précision de 97,5 % dans les études.
Cette approbation marque une expansion stratégique sur le marché du Moyen-Orient, où Biomerica a déjà connu du succès avec son test EZ Detect Colon Disease. Le test Fortel® PSA vise à répondre à la préoccupation croissante concernant le cancer de la prostate, qui est le deuxième cancer le plus couramment diagnostiqué chez les hommes dans le monde, avec 1,4 million de nouveaux cas et 375 000 décès signalés en 2020.
L'entreprise travaille avec des distributeurs régionaux pour rendre la détection précoce du cancer plus accessible, s'appuyant sur son succès précédent à obtenir un remboursement de l'assurance gouvernementale à Dubaï pour son test de dépistage du côlon.
Biomerica (NASDAQ: BMRA) hat die Genehmigung des Ministeriums für Gesundheit und Prävention der Vereinigten Arabischen Emirate für seinen Fortel® PSA Screening Test erhalten, ein 10-minütiges Diagnosetool zur Erkennung von Prostatakrebsmarkern anhand von Blutproben, die durch einen Fingerstich entnommen werden. Der Test hat in Studien eine beeindruckende klinische Leistung mit 100% Sensitivität, 95% Spezifität und 97,5% Genauigkeit gezeigt.
Diese Genehmigung markiert eine strategische Expansion in den Nahostmarkt, wo Biomerica bereits mit seinem EZ Detect Colon Disease Test erfolgreich ist. Der Fortel® PSA-Test zielt darauf ab, der wachsenden Besorgnis über Prostatakrebs entgegenzutreten, der weltweit die zweithäufigste Krebsart bei Männern ist, mit 1,4 Millionen neuen Fällen und 375.000 Todesfällen, die im Jahr 2020 gemeldet wurden.
Das Unternehmen arbeitet mit regionalen Vertriebspartnern zusammen, um die frühzeitige Krebserkennung zugänglicher zu machen und baut auf seinem bisherigen Erfolg auf, die staatliche Versicherungsrückerstattung in Dubai für seinen Darmkrebsscreening-Test zu sichern.
- UAE Ministry of Health approval received for Fortel® PSA Screening Test
- High accuracy rates demonstrated in clinical studies (100% sensitivity, 95% specificity)
- Strategic expansion in Middle East market following previous success with EZ Detect test
- Potential for government insurance reimbursement based on past product precedent
- None.
Insights
The UAE MOHAP approval for Biomerica's Fortel® PSA test represents a significant market expansion opportunity in the Middle East healthcare sector. The test's impressive clinical validation data showing
The Middle Eastern market presents substantial growth potential, particularly given the increasing recognition of prostate cancer as a public health concern in the region. With 1.4 million new cases diagnosed globally in 2020 and prostate cancer being the second most common cancer in men worldwide, the addressable market is substantial. The test's previous success pattern with the EZ Detect Colon Disease test in Dubai, including government insurance reimbursement, suggests a promising pathway for market penetration and revenue generation.
For a micro-cap company with a market cap of just
- Potential government reimbursement similar to their colon test
- First-mover advantage in the regional rapid PSA testing market
- Platform for further Middle East market penetration
Looking at comparable diagnostic markets, the Middle East in-vitro diagnostics market is growing at a CAGR of
- 10-Minute PSA Test for Early Detection of Prostate Specific Antigen (PSA), an Early Warning Sign of Prostate Cancer
- Prostate Cancer: The Second Most Common Cancer in Men Globally
IRVINE, Calif., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of innovative diagnostic solutions, is proud to announce that its Fortel® Prostate Specific Antigen (PSA) Screening Test has received approval from the United Arab Emirates Ministry of Health and Prevention (MOHAP).
The Fortel® PSA Screening Test is a user-friendly diagnostic tool that provides accurate results in just 10 minutes using a simple finger-prick blood sample. By measuring elevated PSA levels, a recognized early marker of prostate disease, the test can enable early detection of prostate cancer and other prostate-related conditions. This rapid and accessible approach aims to enhance proactive health management, reduce the burden on healthcare systems, and improve patient outcomes.
Strategic Expansion in the Middle East
This milestone approval is part of Biomerica’s strategic initiative to expand its footprint in the Middle East, where prostate cancer is increasingly recognized as a critical public health concern. Building on its success in the region with the EZ Detect Colon Disease At-Home Screening Test, which received government insurance reimbursement in Dubai, Biomerica is working to replicating this achievement with the Fortel® PSA test. The Company has established partnerships with leading distributors and secured key regulatory approvals to make early cancer detection more accessible to patients in the region.
Proven Performance
The Fortel® PSA test has demonstrated outstanding performance in rigorous evaluations:
- A study reported
100% sensitivity,95% specificity, and97.5% accuracy, aligning with laboratory reference methods. - Research conducted at the Faculty of Medicine, Ain Shams University in Egypt, further validated the test’s effectiveness, achieving
97.2% sensitivity,96.2% specificity, and96.7% accuracy.
These results highlight the Fortel® PSA test as a reliable and efficient tool for early detection.
The Growing Global and Regional Impact of Prostate Cancer
Prostate cancer is the second most common cancer among men worldwide, with 1.4 million new cases diagnosed and 375,000 deaths reported globally in 20201. Alarmingly, one new case is diagnosed every two minutes2. While extensive research and advancements in early detection have been made in Europe and North America, 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 and there remains a gap in comprehensive studies within the Middle East3.
Looking Ahead: Expanding Access to Life-Saving Diagnostics
Biomerica is reinforcing its commitment to expanding access to innovative diagnostic solutions in the Middle East. The company’s vision remains focused on providing affordable, accurate, and accessible tools to aid in the early detection and treatment of critical diseases like prostate cancer.
- https://uroweb.org/guidelines/prostate-cancer/chapter/epidemiology-and-aetiology%E2%
80% 8B - https://zerocancer.org/about-prostate-cancer/facts-statistics
- 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. (www.biomerica.com) 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.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company’s current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company’s products and tests, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the Fortel PSA product, and the Company’s other current and future products, the possible expansion in to other markets, uniqueness of the Company’s products, accuracy of the Company’s tests and products, pricing of the Company’s test kits, domestic and/or international market adoption and acceptance and demand for the Company’s products, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company’s inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s test kits and other products; capacity, shipping logistics, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulatory compliance and oversite, and the Company’s ability to obtain patent protection on any aspects of its diagnostic or therapeutic technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.
Corporate Contact:
Zack Irani | CEO
p. 949.645.2111
www.biomerica.com
Source: Biomerica
FAQ
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