Biomerica, Inc. (NASDAQ: BMRA) announced Thursday that the Egyptian Drug Authority (EDA) has approved its full portfolio of rapid diagnostic tests for cancer-related and chronic conditions. The small-cap diagnostics firm, valued at $7.37 million, saw its shares rise 8.55% over the past week following the announcement. According to InvestingPro, Biomerica remains undervalued based on its fair value assessment.
The authorization covers five products: tests for colorectal disease, breast self-examination, prostate disease, kidney disease, and H. pylori infection. Designed for early detection, these tests aim to address prevalent cancers and chronic illnesses in Egypt.
Biomerica highlighted several products in its release. The EZ Detect Colon Disease Test identifies hidden blood in stool within two minutes without handling samples. The Aware Breast Self Exam improves tactile sensitivity during breast examinations. The Fortel Prostate Screening Test detects elevated PSA levels from a finger-prick blood sample. The portfolio also includes the Fortel Kidney Disease Screening Test, which detects elevated urinary albumin as an early marker of kidney damage, and the Fortel Ulcer Screening Test, which identifies H. pylori antibodies.
CEO Zack Irani described the approval as “a milestone in expanding access to early detection in a region with growing chronic disease and cancer burdens.” Despite the positive development, InvestingPro reports that Biomerica remains unprofitable over the past twelve months, with a negative EBITDA of $4.8 million. The company, however, holds more cash than debt, providing financial flexibility for expansion.
The tests are designed for both personal use and larger screening programs in clinics, pharmacies, and hospitals. They require no laboratory processing and deliver rapid results.
Egypt faces significant health challenges related to these conditions. Colorectal cancer is the country’s seventh most common cancer, while breast cancer is the leading cancer among Egyptian women. Around 13% of adults live with chronic kidney disease, and H. pylori infection affects 50-70% of the population.
This approval strengthens Biomerica’s presence in the Middle East and North Africa as it broadens its global diagnostic footprint.
In related news, Biomerica has expanded its Contract Development and Manufacturing Organization (CDMO) services to meet rising demand from large diagnostic companies and smaller innovators. The firm’s enhanced capabilities now support the full product development lifecycle for diagnostic solutions. Additionally, Biomerica appointed Gary Huff, former CEO of LabCorp Diagnostics, to its Board of Directors as an independent member. Huff’s extensive experience in diagnostics and healthcare is expected to reinforce the company’s strategic growth in the market.
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