RESEARCH TRIANGLE PARK – Fresh from a Covid-19 collaboration with Thermo Fisher Scientific, Raleigh-based MAKO Medical Laboratories has teamed up with the global life sciences company again to address the monkeypox outbreak.

MAKO, a national reference laboratory, has validated a PCR-based monkeypox-specific research assay developed by Thermo Fisher, filling a need for more surveillance testing capacity in the United States for the viral infection.

“As the international outbreak of this concerning new virus continues to grow, MAKO Medical is taking a proactive approach,” said Josh Arant, the company’s chief operating officer. “We are pleased to partner with Thermo Fisher Scientific once again to validate their monkeypox assay. 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.”

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The TaqMan Monkeypox Virus Microbe Detection Assay, developed by Applied Biosystems, a genetic analysis business of Thermo Fisher, will help health authorities track and trace the epidemiology of the current outbreak.

The assay is for research use only and not for clinical diagnosis of patients.

Greater specificity

MAKO scientist at work in lab. — MAKO photo

Fewer than 100 laboratories across the country are capable of handling monkeypox specimens before they are sent to the U.S. Centers for Disease Control and Prevention (CDC) for documentation.

Current assays on the market are only able to confirm the presence of orthopoxvirus, a genus that includes smallpox, cowpox, vaccinia and monkeypox viruses. Further testing is required to confirm monkeypox specifically.

Today, positive orthopoxvirus cases are presumed to be monkeypox, creating inefficiency in the current testing strategy, according to MAKO. Thermo Fisher’s research assay is designed to detect monkeypox directly from specimens.

“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. “We will continue to work with our customers and regulatory agencies to bring these products to market.”

‘Evolving health threat’

The World Health Organization (WHO) has declared monkeypox an “evolving health threat” as the number of cases rises.

More than 6,000 cases have been detected in 58 countries, but that total may be low due to a lack of testing, according to WHO. About 600 cases have been confirmed to date in the United States, including three in North Carolina.

Symptoms include fever, muscle pain, swollen lymph nodes and a rash that forms blisters. Cases may be severe, especially in children, pregnant women or people with compromised suppressed immune systems.

There is no known cure for monkeypox.

North Carolina’s contributions

MAKO is at least the third North Carolina bioscience company involved in the monkeypox outbreak.

As previously reported, Burlington-based Labcorp will begin clinical testing for monkeypox using the CDC’s orthopoxvirus test, which it verified for the CDC, and Bavarian Nordic, a Danish vaccines company with a U.S. subsidiary in Morrisville, is providing the only monkeypox vaccine approved by the U.S. Food and Drug Administration.

MAKO’s monkeypox work is an extension of its ongoing collaboration with Thermo Fisher. MAKO teamed up with the company last year to leverage its high-capacity COVID-19 genetic sequencing platforms.

Since April 2020, MAKO has processed more than 12 million COVID-19 tests using Thermo Fisher’s RT-PCR technology and testing assays.

Founded in 2014, MAKO is a College of American Pathologists-accredited laboratory that provides diagnostic services to businesses, physicians, urgent care facilities and hospitals around the United States.

The company 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.

Thermo Fisher, based in Waltham, Mass., is a supplier of tools and services that support the life sciences. It has major operations in North Carolina including its Patheon business, which provides contract drug development and manufacturing services in Greenville and High Point, and its PPD business, which provides clinical drug development and analytical services in Wilmington and Morrisville.

The corporation has annual revenue of about $40 billion.

(C) N.C. Biotech Center