Diagnostic tests developer OncoCyte has reported positive results from the R&D Validation study of its DetermaVu test designed for the identification of lung cancer.
DetermaVu is a non-invasive, liquid biopsy test for confirming the presence of lung cancer. It is meant to minimise the need for invasive biopsies in cases where suspicious lung nodules are detected on medical images.
The test measures biomarkers of the immune system’s response to cancer in order to distinguish malignant lung nodules from benign ones in early-stage lung cancer.
Results showed that the test demonstrated 90% sensitivity and 75% specificity with a cohort of 250 patient blood samples.
OncoCyte said that its new test showed superior accuracy when compared to other liquid biopsy tests and clinical models.
The study did not involve the use of clinical factors such as nodule size, the company noted.
OncoCyte Research and Development senior vice-president Lyndal Hesterberg said: “First, we have demonstrated that the biological basis for DetermaVu, that is, gene expression changes within the immune system in response to cancer, can serve as a highly sensitive and accurate signal in blood for early-stage lung cancer diagnosis.
“Second, we have shown for the first time in a prospective cohort of blinded samples, and without the use of any clinical factors, that DetermaVu has the sensitivity and specificity required for clinical use.”
The company added that its new test could significantly decrease healthcare costs in the US by eliminating the need for unnecessary biopsies.
This would be made possible as the blood test can be used to determine if a patient’s lung nodule should be biopsied for cancer.
If the test result shows benign nodule, the patient can be monitored without a biopsy, in turn avoiding the cost and safety risks of an invasive procedure.
OncoCyte is planning to commercially launch the test in the second half of this year.