About Biotime's spin-off (and holding) Oncocyte's DetermaVu delay (Good news).
Problems with Supplier, and careful science with sufficient toold to track down and correct any variability in the tool itself. These things tend to happen in real life science and serious executives don't avoid their responsibility to correct any error when one is found.
"Our expectation was to complete this study during the fourth quarter. However, during the initial process of running samples for the clinical validation study, our technicians observed inconsistent analytic results. During our analysis of the results of the first samples of the validation study, we noticed some anomalous results with control or housekeeping markers. As well as the biomarkers in the tests that are used to identify whether or not a lung nodule is benign. We include a number of synthetic housekeeping markers that act as controls.
These synthetic biomarker controls are designed to be very stable and they're quantization should remain virtually identical across all tests. In this instance, we noticed that the measured levels of certain housekeeping markers varied significantly from expected levels, thereby revealing variability in the consumables that was not related to the test performance.
And consequently we believe that the inconsistent results were caused by a variance in a recently received lot of the consumables that are used in the processing system that analyzes blood samples. To address this issue, OncoCyte has ordered and is waiting to receive new lots of consumables from the supplier.
Once the new consumables are received, OncoCyte will conduct internal quality control procedures to ensure that they meet our requirements. Upon confirming that the new consumables will allow the analytic device to generate data with the consistency and precision required for DetermaVu, we will initiate the clinical validation study.
Due to the time required for these steps, OncoCyte now anticipates that completion of the clinical validation study necessary for the commercial launch of DetermaVu will be delayed into 2018 depending on the successful rectification of the causes of the inconsistent analytic results.
OncoCyte has only observed this issue in the most recent lot of consumables that we found problems with. Our earlier studies were conducted using different lots of consumables where this problem was not conserved. Consequently, the previous studies were not impacted by this issue and the positive results reported to date have not changed. The positive result seen in those studies are valid and repeating the earlier studies is not necessary and is not being considered."
