The company's validation studies demonstrate that the assay has a 99 percent negative predictive value, which it believes will persuade physicians of its value.
Counsyl believes its data is robust, while Natera has called the methodology and conclusions "gratuitously wrong." Both published opposing response letters this week.
Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.
New data now suggests that evaluating PD-L2 levels might better predict response to PD-1 targeting immune-oncology drugs than current tests that only measure PD-L1.
New data points to strong predictive ability for a ddPCR-based test of AR copy number, while other companies are pursuing tests that target expression of AR splice variants.
The company has achieved even higher specificity than earlier data demonstrated, and is now building up its sales and marketing infrastructure for the planned launch of its lung cancer test.
The company's test measures epigenetic alteration of two genes using Qiagen PCR methods, in order to detect signs of recurrence in colorectal cancer patients post-surgery.
The company will return both a genomic prediction of disease aggressiveness and a read on 10-year risks for metastasis and for disease-specific mortality.
A study demonstrated a connection between Epic's CTC-based PD-L1 assessment and patient outcomes, though clinical validation for immunotherapy prediction is still ongoing.
The firm's first assay will be for Hodgkin lymphoma, but a liquid biopsy test for prostate cancer has also shown strong predictive power in initial validation data.
