Clinical OMICS

JAN-FEB 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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News www.clinicalomics.com January/February 2018 Clinical OMICs 3 Better Luck This Year OncoCyte's Clinical Validation Study for Lung Cancer Diagnostic Delayed O ncoCyte has acknowledged that the clinical validation study for its DetermaVu blood-based lung can- cer diagnostic test won't be completed until 2018, following inconsistencies the company attributes to a quality issue with consumables. The delay pushes into the first quarter, at the earliest, the commer- cial launch of DetermaVu, which was previously anticipated to occur in the second half of 2017 following the clinical validation study, the final development step before commercial launch of the diagnostic. How far into 2018 the launch occurs will depend on how quickly Onco- Cyte can successfully rectify the qual- ity issues it identified. While running initial samples for the clinical validation study, Onco- Cyte said, its technical team observed inconsistent analytic results believed to be caused by a variance in a recently received lot of consumables used in the processing system that analyzes blood samples for the genetic markers that indicate whether lung nodules found in patients are benign or suspicious. "The consumables are cartridges containing reagents that are used in the processing system that analyzes blood samples," OncoCyte President and CEO William Annett told Clinical OMICs. He said OncoCyte has ordered, and is waiting to receive, new lots of con- sumables from its supplier, which it has not identified. The quality issue had not surfaced in earlier studies that used different lots of consumables, according to the company. "Once OncoCyte has received the new consumables from the supplier. It will take the company a number of weeks to complete its internal qual- ity-control screening. When the new consumables pass quality control, the clinical validation study will begin and will take a number of months to complete," Annett said. "If the study is successful, the commercial launch will follow within a few weeks." The clinical validation study for DetermaVu will be designed to assess the performance of the full diagnostic system against clinically confirmed diagnoses. Approximately 300 blinded prospectively collected samples will be assayed to confirm whether the sensitivity and specificity of the test remain within commercial parameters in a CLIA operational setting. The samples have been collected from about 50 sites across the U.S., Annett said. OncoCyte aims to be the first com- pany to provide a highly accurate non-invasive confirmatory blood test for lung cancer. The company has esti- mated that in the U.S., approximately 1.4 million patients annually could benefit from the test. That could result in a market opportunity of up to $4.7 billion annually, according to Onco- Cyte, depending on market penetra- tion and payor reimbursement. OncoCyte advanced DetermaVue into the clinical validation phase in March, following a study whose pos- itive results were "consistent with" an earlier study of the diagnostic by The Wistar Institute of Anatomy and Biology. On September 18, OncoCyte shared positive accuracy results of an ana- lytical validation study that demon- strated sensitivity of 94.4%, specificity of 67.5% and area under the curve (AUC) of 0.93—meaning that 93% of the samples tested were correctly diagnosed. Nine days later, OncoCyte announced the successful comple- tion of a validation study by its CLIA laboratory, which assayed approxi- (continued on page 6) By Alex Philippidis Science Photo Library - SCIEPRO / Getty Images

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