OncoCyte has delayed the introduction of its DetermaVu liquid biopsy test for lung cancer once again.
The test, which at one time was due to come to market in the first half of 2017, is undergoing a Clinical Laboratory Improvement Amendments validation study ahead of a prospective clinical validation study.
OncoCyte expected to complete the studies around the middle of 2019 and bring the test to market by the end of the year but has now abandoned that target.
At one time, OncoCyte anticipated completing the work needed to support a commercial launch in 2016. The forecast gradually slipped from that point on, with a big blow coming in November 2017 when OncoCyte’s clinical validation study generated "inconsistent analytic results." After already missing its targeted launch, it pushed the date back into 2018.
OncoCyte recently looked to have got DetermaVu back on track. The company finished an analytical validation study earlier this year, leaving it with just two sets of tests to run before bringing the liquid biopsy to market.
The first of those sets of tests is taking longer than expected. OncoCyte said it will need "additional time" to finish the CLIA validation study and opted against committing to a new target date for the completion of the development program. In explaining the delay, OncoCyte implied the consistency of the testing process and the results it generates are falling short of the desired standard.
"Due to ongoing efforts to create consistency in this process and to ensure the CLIA assay provides the most consistent, sensitive results for patients the company will continue its development work before releasing the final data," OncoCyte said in a statement.
OncoCyte began the CLIA validation study in April. The study will assay 120 samples previously tested in OncoCyte's R&D validation study to show that tests run in its CLIA laboratory generate the same results. The company said its staff are working "to analyze and address the remaining steps needed to proceed with the CLIA validation study," adding that it will provide a new timeline once they have made progress.
Shares in OncoCyte closed down 37% following the news, eliminating some of the gains the stock made when the company reported results from the R&D validation study earlier in the year. The test linked the test to 90% sensitivity and 75% specificity.