OncoCyte Corp, a developer of noninvasive tests for the early detection of cancer, has announced that its clinical laboratory facility located in Alameda, Calif, has received Clinical Laboratory Improvement Amendments (CLIA) certification from the Centers for Medicare and Medicaid Services (CMS). In addition, OncoCyte’s laboratory has passed inspection by the California Department of Public Health and is now fully licensed and operational.

OncoCyte plans to use its CLIA-certified laboratory to commercialize proprietary cancer diagnostic tests. The company expects to launch its first assay, DetermaVu, a confirmatory lung cancer diagnostic, in the fourth quarter of 2017, assuming successful completion of CLIA validation and clinical validation studies. OncoCyte estimates that a US market worth $4.7 billion annually could develop for confirmatory lung cancer liquid biopsy tests, depending on market penetration and reimbursement pricing.

“Having our CLIA laboratory become operational marks the beginning of our commercial activities in the United States, a key driver of our long-term success,” says Bill Annett, OncoCyte president and CEO. “The receipt of CLIA certification is a testament to the dedication and proficiency of our operations team in Alameda, and I am grateful for the team members’ tireless efforts in achieving this important milestone. The demand for molecular diagnostic testing for cancer is growing rapidly, and CLIA certification of our laboratory positions OncoCyte to enter this exciting emerging field.

“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,” Annett adds. “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.”

For more information visit OncoCyte.

Photo courtesy of OncoCyte Corporation