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OncoCyte begins analytical verification study for lung cancer diagnostic test

MDBR Staff Writer Published 12 August 2016

Blood-based tests developer OncoCyte has commenced the analytical verification study for its lung cancer diagnostic test.

The verification study has been designed to independently replicate the positive research results from a 610-patient study by The Wistar Institute, which was announced in April.

OncoCyte has started the study with the analysis of the first 100 malignant and benign lung cancer samples, which were independently collected by the company.

The company intends to complete the studies by the end of this year.

If the findings are consistent with the earlier Wistar results, the firm plans to apply to the State of California for CLIA certification of its laboratory, in addition to launching the lung cancer diagnostic test in the US during the first half of 2017.

To initiate the study, the company acquired R&D processes from Wistar, including its RNA extraction method and NanoString assay method.

In addition, the firm extended its clinical sample collection efforts and enrolled 20 clinical trial sites for its lung cancer sample collection study.

The company plans to enroll additional collection sites, comprising of lung cancer screening centers, pulmonology clinics and surgical centers.

OncoCyte CEO William Annett said: “The initiation of this verification study is a significant step forward for OncoCyte and it demonstrates our continued progress towards launching our non-invasive lung cancer diagnostic test.

“We plan to conclude our studies later this year, maintaining our timeline to commercialize our blood-based diagnostic test for lung cancer in the first half of 2017.”

OncoCyte is engaged in the development and commercialization of novel, non-invasive blood and urine diagnostic tests for the early detection of cancer.