Aurora, Colorado, June 25, 2021 – – Summit Biolabs, a commercial stage molecular diagnostics company
pioneering saliva liquid-biopsy for the detection of COVID-19, head and neck, and other aerodigestive
tract cancers, announced today receiving its Certification of Compliance (COC). The on-site survey found
the lab to be in substantial compliance with no deficiencies. The survey was performed under the
conditions of participation in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the
lab to perform high-complexity molecular diagnostic tests. This follows the lab’s Certificate of
Registration in February 2021 when the new lab began COVID-19 testing operations. This on-site survey
was conducted by the Colorado Department of Public Health, the CMS CLIA agency for the State of
Colorado.
Summit Biolabs has been supporting public health as well as organizations of all sizes in Colorado and
beyond by providing COVID-19 testing using COVIDFastTM, including SwabFASTTM, the first and only
direct-to-PCR nasal swab test, and SalivaFASTTM, the most accurate direct-to-PCR saliva test. Summit
Biolabs developed and launched these highly accurate, rapid PCR tests for COVID-19 in response to the
pandemic while continuing its work in non-invasive diagnostic testing for head and neck and other
aerodigestive tract cancers.
Bob Blomquist, Chief Executive Officer of Summit Biolabs commented, “We are very pleased that our
laboratory was found to be in substantial compliance during the recent CLIA survey, with no deficiencies
cited. I am so excited that our team was able to secure the CLIA Certificate of Compliance so quickly
after receiving the CLIA Certificate of Registration in February. It is evidence for Summit Biolab’s
commitment to quality laboratory operations and clinical results.”
Summit Biolabs is harnessing the power of saliva liquid-biopsy for the detection of COVID-19, head &
neck, and other aerodigestive tract cancers. Summit is a commercial-stage molecular diagnostics
company spun out from CU Anschutz, with headquarters in Aurora, Colorado. Leveraging our
competencies in viral detection in saliva, we have developed and launched highly accurate, rapid, swab
and saliva PCR tests for COVID-19. Our tests for COVID-19 are SwabFASTTM, the first and only direct-to-
PCR swab test, and SalivaFASTTM, the most accurate direct-to-PCR saliva test. Fulfilling our primary
mission, we are developing HNKlearTM, the first saliva liquid-biopsy test for early detection of head and
neck, and other aerodigestive tract cancers.
