The Saudi Food and Drug Authority (SFDA) Approves Biomerica's At Home PSA Screening Test to Detect Early Signs of Prostate Cancer
Biomerica (Nasdaq: BMRA) has received approval from the Saudi Food and Drug Authority (SFDA) for its Fortel® Prostate (PSA) Screening Test. This at-home test allows men to detect early signs of prostate cancer in just 10 minutes using a finger-prick blood sample. The test has shown impressive performance, with studies reporting up to 100% sensitivity and 97.5% accuracy compared to laboratory methods.
This approval marks Biomerica's strategic expansion into the Middle East, where prostate cancer is a growing concern. The company has already shipped its first order to Saudi Arabia and aims to replicate the success of its EZ Detect Colon Disease test, which has secured insurance reimbursement in Dubai.
Prostate cancer is the second most common cancer in men globally, with 1.4 million new cases diagnosed in 2020. Biomerica's Fortel® PSA test aims to address the need for early detection in the region, where comprehensive studies on prostate cancer are still lacking.
Biomerica (Nasdaq: BMRA) ha ricevuto l'approvazione dall'Autorità Saudita per la Sicurezza Alimentare e dei Farmaci (SFDA) per il suo test di screening Fortel® per il Prostata (PSA). Questo test da casa consente agli uomini di rilevare tempestivamente segni di cancro alla prostata in soli 10 minuti utilizzando un campione di sangue prelevato con una puntura al dito. Il test ha dimostrato prestazioni impressionanti, con studi che riportano fino a 100% di sensibilità e 97,5% di accuratezza rispetto ai metodi di laboratorio.
Questa approvazione segna l'espansione strategica di Biomerica in Medio Oriente, dove il cancro alla prostata è una crescente preoccupazione. L'azienda ha già spedito il suo primo ordine in Arabia Saudita e mira a replicare il successo del suo test EZ Detect per le malattie del colon, che ha ottenuto il rimborso assicurativo a Dubai.
Il cancro alla prostata è il secondo tipo di cancro più comune tra gli uomini a livello globale, con 1,4 milioni di nuovi casi diagnosticati nel 2020. Il test Fortel® PSA di Biomerica mira a rispondere all'esigenza di una diagnosi precoce nella regione, dove mancano ancora studi approfonditi sul cancro alla prostata.
Biomerica (Nasdaq: BMRA) ha recibido la aprobación de la Autoridad Saudí de Seguridad Alimentaria y Farmacéutica (SFDA) para su test de screening Fortel® Prostata (PSA). Este test en casa permite a los hombres detectar signos tempranos de cáncer de próstata en solo 10 minutos utilizando una muestra de sangre obtenida mediante una punción en el dedo. El test ha mostrado un rendimiento impresionante, con estudios que reportan hasta 100% de sensibilidad y 97.5% de precisión en comparación con métodos de laboratorio.
Esta aprobación marca la expansión estratégica de Biomerica en Medio Oriente, donde el cáncer de próstata es una creciente preocupación. La empresa ya ha enviado su primer pedido a Arabia Saudita y busca replicar el éxito de su test EZ Detect para enfermedades del colon, que ha conseguido reembolso de seguros en Dubái.
El cáncer de próstata es el segundo cáncer más común entre los hombres a nivel mundial, con 1.4 millones de nuevos casos diagnosticados en 2020. El test Fortel® PSA de Biomerica busca abordar la necesidad de detección temprana en la región, donde aún faltan estudios exhaustivos sobre el cáncer de próstata.
Biomerica (Nasdaq: BMRA)는 사우디 식품의약품청(SFDA)으로부터 Fortel® 전립선(PSA) 스크리닝 테스트에 대한 승인을 받았습니다. 이 자가 검사는 남성이 손가락을 찔러 채취한 혈액 샘플을 사용하여 단 10분 만에 전립선 암의 초기 징후를 감지할 수 있게 해줍니다. 이 검사는 놀라운 성능을 보여주었으며, 연구에 따르면 실험실 방법과 비교했을 때 최대 100%의 민감도와 97.5%의 정확도를 기록했습니다.
이 승인으로 Biomerica는 전립선암에 대한 우려가 커지고 있는 중동 지역으로 전략적 확장을 하게 되었습니다. 회사는 이미 첫 번째 주문을 사우디 아라비아에 발송하였으며, 두바이에서 보험 환급을 받은 EZ Detect 대장 질환 테스트의 성공을 재현하는 것을 목표로 하고 있습니다.
전립선암은 세계적으로 남성 중 두 번째로 흔한 암으로, 2020년에 140만 건의 새로운 사례가 진단되었습니다. Biomerica의 Fortel® PSA 테스트는 종합적인 전립선암 연구가 부족한 이 지역에서 조기 발견의 필요성을 충족하고자 합니다.
Biomerica (Nasdaq: BMRA) a reçu l'approbation de l'Autorité Saoudienne de Sécurité Alimentaire et des Médicaments (SFDA) pour son test de dépistage Fortel® Prostate (PSA). Ce test à domicile permet aux hommes de détecter des signes précoces de cancer de la prostate en seulement 10 minutes à l'aide d'un échantillon de sang prélevé par piqûre au doigt. Le test a montré des performances impressionnantes, avec des études rapportant jusqu'à 100 % de sensibilité et 97,5 % de précision par rapport aux méthodes de laboratoire.
Cette approbation marque l'expansion stratégique de Biomerica au Moyen-Orient, où le cancer de la prostate est une préoccupation croissante. L'entreprise a déjà expédié sa première commande en Arabie Saoudite et vise à reproduire le succès de son test EZ Detect pour les maladies du côlon, qui a obtenu un remboursement d'assurance à Dubaï.
Le cancer de la prostate est le deuxième cancer le plus courant chez les hommes dans le monde, avec 1,4 million de nouveaux cas diagnostiqués en 2020. Le test Fortel® PSA de Biomerica vise à répondre à la nécessité d'une détection précoce dans la région, où les études complètes sur le cancer de la prostate font encore défaut.
Biomerica (Nasdaq: BMRA) hat die Genehmigung der Saudi Food and Drug Authority (SFDA) für seinen Fortel® Prostata (PSA) Screening-Test erhalten. Dieser Heimtest ermöglicht es Männern, frühe Anzeichen von Prostatakrebs innerhalb von nur 10 Minuten mithilfe einer fingerprick Blutprobe zu erkennen. Der Test hat beeindruckende Ergebnisse gezeigt, wobei Studien eine 100%ige Empfindlichkeit und 97,5%ige Genauigkeit im Vergleich zu Laborverfahren berichten.
Diese Genehmigung markiert die strategische Expansion von Biomerica in den Nahen Osten, wo Prostatakrebs eine wachsende Sorge darstellt. Das Unternehmen hat bereits seine erste Bestellung nach Saudi-Arabien versendet und zielt darauf ab, den Erfolg seines EZ Detect Tests auf Dickdarmkrankheiten, der in Dubai eine Versicherungserstattung erhalten hat, zu wiederholen.
Prostatakrebs ist die zweithäufigste Krebserkrankung bei Männern weltweit, mit 1,4 Millionen neu diagnostizierten Fällen im Jahr 2020. Der Fortel® PSA-Test von Biomerica soll die Notwendigkeit einer frühen Erkennung in der Region ansprechen, in der umfassende Studien zu Prostatakrebs noch fehlen.
- SFDA approval for Fortel® Prostate (PSA) Screening Test in Saudi Arabia
- First order of Fortel® PSA Screening Tests shipped to Saudi Arabia
- Test shows 100% sensitivity, 95% specificity, and 97.5% accuracy in studies
- Strategic expansion into the Middle East market
- Potential for insurance reimbursement based on success of EZ Detect Colon Disease test in Dubai
- None.
Insights
The SFDA's approval of Biomerica's Fortel® Prostate (PSA) Screening Test marks a significant advancement in prostate cancer detection for Saudi Arabia. With
Biomerica's strategic expansion into the Middle East, starting with Saudi Arabia, presents a significant market opportunity. The region's growing awareness of prostate cancer as a public health concern aligns perfectly with the company's product offering. Biomerica's success in securing insurance reimbursement for its colon disease test in Dubai sets a promising precedent for the Fortel® PSA test. If replicated, this could drive widespread adoption and boost revenues. The first order shipment to Saudi Arabia indicates immediate market traction. However, challenges may include competition from traditional screening methods and the need for extensive education to promote at-home testing. The company's ability to navigate regulatory landscapes and secure partnerships will be important for capitalizing on this market potential.
This regulatory approval represents a positive development for Biomerica (NASDAQ: BMRA), potentially opening up a new revenue stream in the lucrative Middle Eastern market. The global prostate cancer diagnostics market is projected to grow significantly and Biomerica's entry into Saudi Arabia positions it to capture market share in an underserved region. However, investors should note that the financial impact may take time to materialize. Key factors to watch include:
- Sales volume and adoption rates in Saudi Arabia
- Progress in securing approvals and reimbursements in other Middle Eastern countries
- Margins on the Fortel® PSA test compared to Biomerica's other products
- 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
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.
- https://uroweb.org/guidelines/prostate-cancer/chapter/epidemiology-and-aetiology%E2%
80% 8B (accessed 05 Aug 2024) - https://zerocancer.org/about-prostate-cancer/facts-statistics (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. (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, 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 individuals or by physicians to treat their patients. 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 as needed, 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
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