- Less invasive nasal swab taken from front opening of the nose is more comfortable for patients
- Test can be performed by doctors, school and company nurses, and medical assistants, in any location without specialized equipment
IRVINE, Calif., May 11, 2021 (News) — Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, announced that its new COVID-19 Antigen Rapid Test can now be performed with a simple less invasive nasal swab. This simple nasal swab, which takes the sample from the front opening of the nose, is less invasive and more comfortable for patients than the deep anterior nasal swab which is typically used. The test is highly portable, cost effective and provides visual results negating the need for any equipment to perform or read the test. The test also provides results in 15 minutes versus lab-run PCR tests which can take up to three days for results, thereby potentially expediting the process of identifying infectious people and preventing further spread of the virus.
Zack Irani, CEO at Biomerica, commented, “COVID-19 testing will be with us well past the pandemic, and ensuring that health care professionals have a simple, reliable testing solution is imperative. Our nasal swab test is simple to use, accurate and portable.”
Mr. Irani continued, “It is important to note that while we continue to utilize and apply our diagnostic know-how to COVID-19 tests, our primary focus remains the validation and commercialization of our InFoods® diagnostic platform. We believe that InFoods® is a revolutionary approach to the diagnosis and treatment of Irritable Bowel Syndrome and other gastrointestinal diseases and we continue to work tirelessly to bring these products to market.”
About the Biomerica COVID-19 Rapid Antigen Test: The Biomerica COVID-19 Rapid Antigen Test is intended to identify people who are currently infected and who should quarantine to help prevent the spread of the disease. No lab equipment is necessary to process the test or read the tests results. This test uses lateral flow technology, making it a reliable and familiar format for mass testing by healthcare providers. In independent testing at clinics in three different countries outside of the U.S., the Biomerica COVID-19 Rapid Antigen Test demonstrated an overall performance of 92.5% positive agreement (sensitivity) and 100.0% negative agreement (specificity) as compared to lab-based molecular PCR tests. The Biomerica COVID-19 Rapid Antigen Test was engineered for near-patient, point-of-care settings. A simple nasal swab is used to collect specimens from people suspected of having an active infection. Patient samples should be tested immediately and should not be diluted or used with viral transport media or frozen specimens. The test Is CE marked and targeted for use outside the United States.
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’s primarily focus is on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.
About InFoods® The Biomerica InFoods® IBS product is designed to allow physicians to identify patient-specific foods (e.g., eggs, broccoli, wheat, potatoes, pork, etc.), that when removed from the diet, may alleviate or improve an individual’s IBS symptoms including, but not limited to, constipation, diarrhea, bloating, pain and indigestion. This patented, diagnostic-guided therapy is designed to allow for a patient-specific, guided dietary regimen to improve IBS outcomes. A point-of-care version of the product is being developed to allow physicians to perform the test in-office using a finger stick blood sample, while a clinical lab version of the product is expected to be the first for which the company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians’ offices is already available for InFoods® products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects. An estimated 45 million people in America currently suffer from IBS making it a leading cause for patient doctor visits.
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 efficacy of the Company’s COVID-19 tests, FDA clearance of the Company’s products, EUA clearance, the rapidity of testing results, uniqueness of the Company’s products, test result accuracy of products, pricing of the Company’s test kits, demand for domestic or international orders, potential revenues from the sale of current or future products, availability of the Company’s COVID-19 test kits, and patent protection on any of the Company’s products or technologies. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s COVID-19 tests, InFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s COVID-19 test kits and other products; capacity, 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 COVID-19 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; regulations and the Company’s ability to obtain patent protection on any aspects of its rapid test 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.
John Nesbett /Jennifer BelodeauIMS Investor Relations203.email@example.com
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