|OncoCyte Receives CLIA Certification for its Cancer Diagnostics Laboratory|
“Having our CLIA laboratory become operational marks the beginning of our commercial activities in the U.S., a key driver of our long-term success. The receipt of CLIA certification is a testament to the dedication and proficiency of our operations team in
Mr. Annett continued, “We believe DetermaVu™ will aid physicians in the early diagnosis of lung cancer and in a majority of cases eliminate the need for expensive, invasive lung biopsies. We expect that a reduction in the number of lung biopsies performed annually, coupled with improvements in treatment at an early stage of disease, could lead to a significant reduction in the cost burden to the healthcare system while improving the survival rate of lung cancer patients.”
Under CLIA, a laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease, or the impairment of, or assessment of health of human beings. CLIA requires that the Company holds a certificate applicable to the complexity of the categories of testing performed and that compliance with certain standards. CLIA further regulates virtually all clinical laboratories by requiring that they comply with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure that the clinical laboratory testing services are accurate, reliable and timely. CLIA certification is also a prerequisite to be eligible to be reimbursed for services provided to state and federal health care program beneficiaries.
DetermaVu™ is a trademark of
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