Benzinga | Jan 12, 2021 08:20AM EST

Biomerica Receives CE Mark For Its COVID-19 Rapid Antigen Test

* Biomerica receives first orders and plans to ship tests in coming weeks

* Clinical studies demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% negative agreement (specificity) as compared to lab-based molecular PCR tests

IRVINE, Calif., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ:BMRA), a global provider of advanced medical products, today announced it has received CE Mark for its new COVID-19 Rapid Antigen Test for detection of COVID-19 infection. The Company has already received its first European orders and plans to ship the first part of these orders in the coming weeks. The Company will now begin marketing this product broadly in Europe and other regions outside of the US.

Biomerica's new COVID-19 Antigen Rapid Test is highly portable, affordable, and provides results in 15 minutes with no equipment required to perform or read the test. Because this test can be performed by doctors, nurses, school nurses, and medical assistants, the Biomerica COVID-19 Rapid Antigen Test can be performed at the point of care, outside of medical labs, taking pressure off of labs performing COVID-19 testing. 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 so they don't spread the disease to others.

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 US, the Biomerica COVID-19 Rapid Antigen Test demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% 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.

"We are pleased to launch the Biomerica COVID-19 Rapid Antigen Test to help combat this ongoing global pandemic and which may help people become more confident about their own health," said Zack Irani, CEO at Biomerica. "While we are proud to be contributing to the management of the current global pandemic and help bring more normalcy into our lives, our primary focus remains the validation and commercialization of products that are based on our patented InFoods(r) technology platform. We continue to believe our InFoods(r) products could revolutionize the way people are diagnosed and treated for a variety of common diseases including Irritable Bowel Syndrome (IBS). As such, we see a large potential for helping the millions of patients suffering with IBS," he concluded.