The Saudi Food and Drug Authority (SFDA) Approves Biomerica's At Home PSA Screening Test to Detect Early Signs of Prostate Cancer

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

- 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.

1. https://uroweb.org/guidelines/prostate-cancer/chapter/epidemiology-and-aetiology%E2%80%8B (accessed 05 Aug 2024)
2. https://zerocancer.org/about-prostate-cancer/facts-statistics (accessed 05 Aug 2024)
3. 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

FAQ

What is the accuracy of Biomerica's Fortel® PSA Screening Test?

Studies have shown that Biomerica's Fortel® PSA Screening Test has up to 100% sensitivity, 95% specificity, and 97.5% accuracy compared to laboratory reference methods.

How long does it take to get results from Biomerica's PSA Screening Test?

The Fortel® Prostate (PSA) At-Home Screening Test delivers highly accurate results within just 10 minutes.

Has Biomerica (BMRA) started selling its PSA test in Saudi Arabia?

Yes, Biomerica has shipped the first order of Fortel® PSA Screening Tests to its distributors in Saudi Arabia following SFDA approval.

What is the global incidence of prostate cancer according to Biomerica's press release?

According to the press release, approximately 1.4 million new cases of prostate cancer were diagnosed globally in 2020, resulting in 375,000 deaths.

How does Biomerica's Fortel® PSA test work?

The Fortel® PSA test uses a simple finger-prick blood sample to measure elevated PSA levels, which can be an early indicator of prostate disease, including cancer.