OncoCyte has acknowledged that its clinical validation study for its DetermaVu blood-based lung cancer diagnostic test won’t be completed until 2018, following inconsistencies the company attributes to a quality issue with consumables.
The delay pushes into the new year, at the earliest, the commercial launch of DetermaVue, 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 OncoCyte can successfully rectify the quality issues it identified.
While running initial samples for the clinical validation study, OncoCyte 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 consumables 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 quality 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 company to provide a highly accurate non-invasive confirmatory blood test for lung cancer. The company has estimated 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 OncoCyte, depending on market penetration and payor reimbursement.
OncoCyte advanced DetermaVue into the clinical validation phase in March, following a study whose positive 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 analytical validation study that demonstrated 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 completion of a validation study by its CLIA laboratory, which assayed approximately 120 samples previously tested in a 299-patient study whose results were presented at the American Thoracic Society (ATS) 2017 International Conference, held May 19-24 in Washington, D.C. The CLIA validation was aimed at demonstrating that OncoCyte’s new clinical laboratory could provide the same results on clinical samples as those obtained in its R&D lab.
“The clinical validation study has now begun and is expected to be completed in the fourth quarter of 2017,” OncoCyte stated following completion of the CLIA validation study.
OncoCyte disclosed the delay of its clinical validation study on November 14. Soon after, the company’s shares on the New York Stock Exchange fell in price 25% over the following four trading days, dropping from a close of $5.90 on November 14 to a close of $4.40 on November 20. Zacks Investment Research on November 18 lowered its rating on Oncocyte from “hold” to “sell.”
The day after the delay was disclosed, OncoCyte’s announced the appointment a new CFO with 33 years of financial industry experience and expertise in fundraising for early-stage companies. Mitch Levine previously served as managing partner of Kirby Cove Capital Advisors, a provider of consulting services to international life sciences investment funds focused on collaboration and investment in US-based life sciences companies.
“The delay had no impact on the timing of the CFO appointment,” Annett said. “The company had been engaged in a CFO search for a number of months and are very pleased that its top candidate, Mitch Levine, has joined OncoCyte.”