Mirimus Monkeypox Laboratory Developed Test (LDT) Approved


Mirimus, a leading provider of high-quality virology testing, launched its lab-developed test (LDT) for monkeypox detection. The test is a highly sensitive and specific PCR assay with the ability to detect very low concentrations of the virus. Patients who suspect they may have been infected should see their healthcare provider to submit specimens and have it sent to Mirimus for testing. Secure online results will be available within only 24 hours of the lab receiving specimens. Health care providers can inquire about ordering monkeypox tests at testing@mirimus.com or tel:+18336474687.

When COVID-19 hit New York City and it became the epicenter of the pandemic, Mirimus developed a pioneering high-volume COVID-19 PCR testing approach called SalivaClear® performing more than 3.5 million tests and servicing hundreds of schools, businesses, and government organizations across the country. The company has invested heavily in cutting-edge technology and uniquely skilled personnel to reliably and rapidly develop novel pathogen-specific diagnostic testing methods that enhance infectious disease response capacity.

“We have been using the lessons from the COVID-19 response to implement forward-looking measures that strengthen our ability to respond to a wide array of future biosecurity threats. Never has our mission been more important: the COVID-19 pandemic persists and monkeypox poses a new health threat globally,” said Dr. Prem Premsrirut, founder and CEO of Mirimus.

The return on Mirimus’ investment is clear: the company was able to launch its monkeypox laboratory developed test (LDT) shortly after the World Health Organization declared monkeypox to be a global health emergency. Testing is critical to identify the extent of an outbreak, contain it, and to ensure patients can get access to treatment. Mirimus has received authorization from the New York State Department of Health at Wadsworth to perform this diagnostic Monkeypox LDT under the CLEP program and will continue to adjust its assay as new mutations arise. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

About Mirimus:

Mirimus is an award-winning New York biotech company that propels the scientific research behind medical breakthroughs. The company addresses human health issues on a global scale by pioneering ways to diagnose and treat diseases, and by creating animal and cell models for cutting-edge medical research. Founded in 2010 by Prem Premsrirut, MD, PhD, Mirimus has partnered with leading institutions around the world, allowing it to deepen its understanding of molecular diagnostics, genetic engineering, and RNAi therapeutics. In 2020, Mirimus committed its resources to support the fight against COVID-19 and built a long-term biosecurity infrastructure to slow the spread of future infectious disease outbreaks. For more information, please visit http://www.mirimus.com.

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