The Wistar Institute and BioTime, Inc's subsidiary OncoCyte Corporation, have expanded their collaborative relationship to develop a simple, non-invasive, blood-based test designed to aid physicians in the early detection of lung cancer.

This expanded collaboration follows earlier clinical trials, the interim results of which were presented at the May 2015 American Thoracic Society (ATS) International Conference. Wistar is an international biomedical research leader in cancer, immunology and infectious diseases. OncoCyte is a developer of novel, non-invasive liquid biopsy products for the early detection of cancer.

In October 2013, OncoCyte entered into a sponsored research agreement with The Wistar Institute, a National Cancer Institute-designated cancer center, to develop and test potential lung cancer biomarkers identified by Dr. Louise Showe, Ph.D., professor in Wistar’s molecular and cellular oncogenesis programme.

Under the new expanded agreement, OncoCyte and Wistar will continue their collaboration with the goal of developing a highly sensitive and specific diagnostic test for the early detection of lung cancer. Critical to the success of the next phase of the research and development programme will be the analysis of an expanded patient sample set, the transition of sample analysis to a platform capable of commercial scale operations, confirmation of mRNA and miRNA expression, and completion of diagnostic test verification activities.

“I look forward to continuing this productive relationship between my lab at Wistar and our collaborators at OncoCyte,” said Dr. Showe, professor, Wistar’s molecular and cellular oncogenesis programme; associate director, Center for Systems and Computational Biology; scientific director, Genomics Facility; and scientific director, Bioinformatics Facility.

“Lung cancer takes a terrible toll on life and productivity every year. We hope we can impact that toll in some meaningful way, through the ongoing studies.”

“We look forward to building on the initial success of our partnership with The Wistar Institute, and are excited about our progress to date,” said William Annett, chief executive officer of OncoCyte.

“As we continue to develop our liquid biopsy for the early detection of lung cancer, we are enthusiastic about the opportunity to have a major impact on the lives of those that suffer from lung cancer.”

In May 2015, OncoCyte and The Wistar Institute announced the interim results of a large, clinical study conducted by Dr. Showe and funded by OncoCyte. The clinical interim results from a blood-based diagnostic test for non-invasive detection of lung cancer were presented at the American Thoracic Society (ATS) International Conference. These results from the assayed samples demonstrated a high level of observed sensitivity and specificity of a simple blood-based test designed to aid physicians in the early detection of lung cancer. Performance of the classifier was evaluated using several criteria, including receiver operating characteristic (ROC) area under the curve (AUC) analysis, and yielded an AUC of 0.88 (sensitivity of 76 per cent with a specificity of 88 per cent) in the test set.

Dependent on achieving successful scientific and technical results at this stage of development, OncoCyte and Wistar will proceed to final validation of the test with the goal of completing that work in 2016 to enable OncoCyte to commercially launch the lung diagnostic test.

OncoCyte has exercised options to obtain exclusive licenses to any inventions, discoveries or technology developed in the course of the collaborative research and expects to finalise definitive license agreements with Wistar in the near future.

Lung cancer remains a primary cause of cancer-related death in part because there is no effective diagnostic test to screen patients for lung cancer at an early stage. Annual screening for lung cancer in certain high-risk patients was recently recommended by the United States Preventive Services Task Force (USPSTF), an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services. The Task Force recommended screening using low-dose computed tomography (CT) scans. Although low-dose CT scans have demonstrated high sensitivity in detecting early-stage lung cancer in large clinical studies, it also has a relatively high false-positive rate of approximately 25 per cent. False positives can lead to unnecessary costs and side effects due to the need for highly-invasive diagnostic procedures such as bronchoscopies and lung biopsies.

Large-scale screening of patients at high risk for lung cancer, an estimated seven to ten million patients per year in the US, could reduce overall lung cancer mortality through earlier detection. However, the high number of false-positive low-dose CT tests could lead to significant unnecessary costs to the US health care system as a result of associated follow-up testing. Physicians, payers, and patients may therefore welcome a simple to use, low-cost, blood-based test that can help guide patient-management decisions by noninvasively ruling out the presence of cancer.