MAKO Medical Laboratories, a national reference laboratory, today announced it has validated a PCR-based monkeypox-specific assay developed by Thermo Fisher Scientific.

The work is in response to the need for more surveillance testing capacity in the United States for monkeypox. There are currently fewer than 100 laboratories across the country capable of handling monkeypox specimens before they are sent to the US Centers for Disease Control and Prevention (CDC) for documentation purposes. The Applied Biosystems TaqMan Monkeypox Virus Microbe Detection Assay will provide additional testing resources to enable health authorities to track and trace the epidemiology of the current outbreak.

Current assays on the market are only able to confirm the presence of orthopoxvirus, requiring further confirmation of monkeypox by the CDC. Thermo Fisher’s research assay is designed to detect monkeypox directly from specimens. Today, positive orthopoxvirus cases are presumed to be monkeypox, creating inefficiency in the current testing strategy.

“As the international outbreak of this concerning new virus continues to grow, MAKO Medical is taking a proactive approach. We are pleased to partner with Thermo Fisher Scientific once again to validate their monkeypox assay,” said Josh Arant, Chief Operating Officer, MAKO Medical. “MAKO Medical is always on the cutting edge of test development and is committed to providing public health authorities with the tools they need to oversee an effective response.”

“Similar to our efforts during the COVID-19 pandemic, we are committed to providing genomic tools necessary to help address the Monkeypox outbreak,” said Manoj Gandhi, Senior Director of Medical Affairs for Genetic Testing Solutions at Thermo Fisher Scientific. “We will continue to work with our customers and regulatory agencies to bring these products to market.”

The development marks an extension of Mako Medical’s ongoing collaboration with leading life sciences company Thermo Fisher. MAKO Medical established a collaborative relationship with the company last year to leverage its high-capacity COVID-19 next-generation sequencing platforms, which provide high-quality data. Since April 2020, MAKO Medical has processed more than 12 million COVID-19 tests utilizing Thermo Fisher’s RT-PCR technology and industry-leading testing assays.

Founded in 2014, MAKO Medical is a College of American Pathologists (CAP) accredited laboratory that operates more than 70,000 square feet of laboratory space across two North Carolina facilities, one in Henderson and one in Raleigh. The Henderson facility was expanded in 2020 in response to COVID-19, increasing the lab’s capacity from 50,000 COVID-19 tests per day to over 150,000 tests per day.