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MAKO Medical Prepared to Detect Omicron Variant

North Carolina lab provides nationwide sequencing of COVID-19 samples, identifying mutations and variants

November 30, 2021

MAKO Medical Laboratories, a national reference laboratory and leader in COVID-19 testing, today announced preparedness to detect the potential emergence of the Omicron Variant, with significant available capacity for sequencing and PCR testing.

“The qPCR assay our MAKO Medical team deploys checks for all three targets in a COVID-19 positive test result, the N gene, S gene, and ORF1ab,” said Josh Arant, Chief Operating Officer, MAKO Medical. “This is important because unlike the delta variant, which produces a signal for all three targets, early indication shows that the omicron variant is unique in that it will only produce a signal for the N gene and the ORF1ab gene. The TaqPath assay can be used as a proxy for the Omicron variant.”

Earlier this year, MAKO Medical formed a comprehensive partnership with the Centers for Disease Control and Prevention (CDC) to provide next-generation sequencing of SARS-CoV-2. Since January 2021, MAKO has utilized sequencing processes to analyze a group of more than 2,500 samples for sequencing per week from tests conducted across more than 40 states. To date, these efforts have identified the occurrence of multiple variants of the SARS-CoV-2 virus, including the B.1.1.7, B.1.351, B.1.429 and B.1.617.2 variants.

“While we pray the Omicron Variant does not become widespread in the United States, the MAKO team is actively monitoring for it and prepared to report its emergence,” said Arant. “In previous months, our sequencing team identified the emergence of several other strains. As new strains are defined, MAKO continues to sequence samples and provide important data to public health professionals. Our College of American Pathologists (CAP) accredited laboratory operates 24/7 with capacity for 150,000 tests per day.”

MAKO Medical partnered with leading life sciences company Thermo Fisher Scientific to leverage its high-capacity sequencing platforms, which provides high-quality sequencing data. Additionally, Thermo Fisher has confirmed that its polymerase chain reaction (PCR) TaqPath COVID-19 Combo Kit*, and TaqPath COVID-19 CE-IVD RT-PCR Kit*, which test for the presence of SARS-CoV-2, are not impacted by the emerging B.1.1.529, or Omicron variant, enabling accurate test results.

Since the emergence of COVID-19, scientists have monitored the surge of variants and mutations of the virus. While a natural process for any virus, mutations of SARS-CoV-2 represent an outsized risk due to the impact that they may have on virus containment and vaccine efficacy.

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 COVID19 tests per day to over 150,000 tests per day.

Since April 2020, MAKO Medical has processed more than 9 million COVID-19 tests utilizing RT-PCR technology and industry-leading testing assays, including the Applied Biosystems TaqPath COVID-19 Combo Assay. Currently, the MAKO team processes more than 30,000 COVID-19 samples per day from over 40 states.

MAKO’s team also provides turnkey K-12 COVID-19 testing in several states and has begun providing onsite workplace and large gathering COVID-19 testing with mobile units that can be dispatched to rapidly serve group needs. To learn more about workplace and large gathering COVID-19 testing visit To learn more about K-12 COVID-19 testing visit

Company Highlights:

  • For the past two years, Forbes Magazine has included MAKO Medical in its inaugural list of America’s Best Startup Employers. Only 500 companies nationwide earned the distinction.
  • August 2020, MAKO Medical announced the company scored 100% on CAP COVID Proficiency Testing, demonstrating MAKO’s commitment to quality lab results.
  • Committed to the U.S. Military—At MAKO’s founding, leaders carved out divisions of the company to hire U.S. military veterans. These teams are foundational to MAKO’s elite and high-touch client services model. In November 2021, MAKO held its second annual Veterans Day lunch to honor veterans, handing out more than 400 free meals Vance County veterans and their family members.
  • May 2021, MAKO Medical was recognized by the Triangle Business Journal with a 2021 Life Sciences Award.


***INCLUDED PHOTO: Lauren Moon, NGS and R&D Lead Scientist, Genomics at MAKO Medical works on the team supporting COVID-19 sequencing for the CDC. Photo location: MAKO Medical laboratory in Henderson, NC.