Rapid, At-Home PSA Screening Test Gains Approval in UAE for Early Detection of Prostate Cancer

The United Arab Emirates Ministry of Health and Prevention (MOHAP) has approved the Fortel® Prostate Specific Antigen (PSA) Screening Test for the rapid, at-home detection of early indicators of prostate cancer.1

This diagnostic tool was designed to deliver accurate results in approximately 10 minutes using a finger-prick blood sample. By detecting elevated PSA levels, a well-established early marker of prostate disease, the test facilitates early detection of prostate cancer and related conditions. This rapid and accessible approach aims to improve proactive health management, alleviate health care system burdens, and enhance patient outcomes.

The Fortel PSA test has demonstrated high sensitivity and specificity across several studies. One such study reported 100% sensitivity, 95% specificity, and 97.5% accuracy with the test; according to Biomerica, the test’s developer, these outcomes were consistent with laboratory reference methods.

Additional data from a prospective cohort clinical study in Egypt affirmed the test as a straightforward, feasible, and reliable tool for prostate cancer screening relative to a conventional quantitative assay.2 The study was conducted at the Tertiary Care Hospital at the Urology Department, Outpatient Clinic, Faculty of Medicine, at Ain Shams University from January 2022 to June 2022. All patients were required to be male and older than 50 years of age or 40 years of age with a family history of prostate cancer.

A total of 150 patients were included in the study, 12 of whom were later excluded based on inclusion criteria; 8 patients also refused to participate. The mean age at baseline was 57.73 years (standard deviation, ±4.90). A blood sample of approximately 5 ml was collected from each patient prior to administration of the Fortel PSA test for comparative purposes.

In the overall population, the clinical PSA value was negative vs positive in 52% vs 48% of patients, respectively. Comparatively, the Fortel PSA test value was negative for 51.3% of patients and positive for 48.7% of patients. The median PSA value was 3.8 (interquartile range, 2.3-8).

Results indicated high sensitivity (97.2%), specificity (96.2%), positive predictive value (95.9%), and negative predictive value (97.4%) of the Fortel PSA test.

Moreover, there was a statistically significant difference between the interpretation of PSA negativity and positivity regarding Fortel PSA value (P < .01). Among patients with a PSA value less than 4 ng/ml (n = 78), 96.2% were correctly interpreted as negative using the Fortel PSA test vs 3.8% who were interpreted as positive. Similarly, 97.2% of patients with a PSA value more than 4 ng/ml (n = 72) were correctly interpreted as positive using the Fortel PSA test; 2 were interpreted as negative. No statistically significant difference between negative and positive Fortel PSA tests was observed regarding the mean age of the studied patients (P > .05).

Investigators noted that the results of the Fortel PSA test were comparable to those of other one-step PSA tests reported in prior literature. Based on these results, they added that the lower cost, ease of handling, and rapid procedure could make this test useful in the general practitioner or urologist office setting, as well as for mass primary screening in prostate cancer.

Notably, in September 2024, the Saudi Food and Drug Authority granted approval for the Fortel PSA test to be marketed and used in the country.3

Ultimately, this regulatory decision reflects the company’s efforts to strategically expand its products into the Middle East, a region where prostate cancer is considered an increasing public health concern, and where Biomerica has successfully integrated its EZ Detect Colon Disease Test.1,3

References

1. United Arab Emirates Ministry of Health and Prevention approves Biomerica’s Fortel® PSA screening test to detect an early sign of prostate cancer. News Release. Biomerica. January 16, 2024. Accessed January 17, 2025. https://www.biospace.com/press-releases/united-arab-emirates-ministry-of-health-and-prevention-approves-biomericas-fortel-psa-screening-test-to-detect-an-early-sign-of-prostate-cancer
2. Gad HH, Ali AM, Elsaid MH, et al. Evaluation of Fortel prostate-specific antigen test versus conventional quantitative prostate-specific antigen assay. Egyptian Journal of Surgery.2022;41(3)1423-1427. doi:10.4103/ejs.ejs_214_22
3. The Saudi Food and Drug Authority (SFDA) approves Biomerica’s at home PSA screening test to detect early signs of prostate cancer. News Release. Biomerica. September 5, 2024. January 17, 2024. https://www.biospace.com/press-releases/the-saudi-food-and-drug-authority-sfda-approves-biomericas-at-home-psa-screening-test-to-detect-early-signs-of-prostate-cancer