Genomic Health has launched a new liquid biopsy test, the Oncotype DX AR-V7 Nucleus Detect, to predict treatment response for patients suffering from metastatic castration-resistant prostate cancer (mCRPC) in the US.
Developed by Epic Sciences using its No Cell Left Behind platform, the test is formulated to identify a splice variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumour cells (CTCs).
As AR-V7 is a prognostic and predictive biomarker, its presence is said to indicate that common androgen receptor-signalling inhibitor (ARSI) therapies will not work for the particular patient.
This prediction is intended to aid in deciding a further treatment plan for patients using an ARSI therapy, including enzalutamide and abiraterone, who can switch over to chemotherapy or other ARSI therapies.
Genomic Health chief medical officer Phil Febbo said: “The technology from our collaboration partner, Epic Sciences, powers the Oncotype DX AR-V7 Nucleus Detect test, providing an unbiased approach to minimise the risk of CTCs being missed, resulting in superior test performance, sensitivity and specificity.
“The launch of the Oncotype DX AR-V7 Nucleus Detect test marks an important step forward in our mission to use biology to guide care across the prostate cancer continuum by providing urologists with a suite of actionable genomic tests.”
According to the firm, knowing AR-V7 status before planning treatment will help nearly 50,000 men suffering from advanced prostate cancer across the country.
The Oncotype DX AR-V7 Nucleus Detect test is reported to have accurately detected AR-V7 positive patients from a single blood draw during two clinical studies led by Memorial Sloan Kettering Cancer Center (MSK).
Results showed that out of the total 360 subjects, around 20% initially treated with ARSI therapy went on to became AR-V7 positive and developed drug resistance. The survival rate of such patients was found to have increased upon switching to chemotherapy.