OncoCyte has commenced an analytical validation study on its liquid biopsy test DetermaVu Lung, which is designed to detect cancer.
DetermaVu helps compare imaging modalities such as low-dose computed tomography (LDCT) that identify suspicious lung nodules.
Required to commercialise DetermaVu, the validation study will assess the machine’s performance in a variety of factors such as quantitation, precision, reproducibility and interfering substances.
OncoCyte president and CEO William Annett said: “We are very pleased to have initiated the analytical validation study, the next critical step toward the completion of development of DetermaVu.
“Importantly, we already have in-house all of the required patient blood samples allowing us to advance efficiently through this study.”
OncoCyte reported positive results from a research and development (R&D) validation study conducted in January this year. The test demonstrated 90% sensitivity and 75% specificity in a cohort of 250 patient blood samples, with high-accuracy compared with other liquid biopsy tests and clinical models.
Successful completion of the analytical validation will be followed by Clinical Laboratory Improvement Amendments (CLIA) accredited clinical validation studies.
OncoCyte hopes to commercially launch the lung cancer test in the second half of this year. The company anticipates a $4.7bn annual market to emerge for its device in the US, subject to market penetration and reimbursable pricing.