BioView Ltd. (TASE:BIOV) announced today that it has signed a cooperation agreement with OncoMDx of California, to develop a noninvasive diagnostic test for the early detection of non-small cell lung cancer (NSCLC).
The agreement grants OncoMDx exclusive rights to market the test as a Laboratory Developed Test (LDT), after performing internal validation.
The test, which uses BioView's scanners to test patients' phlegm, was first developed at the University of Texas' MD Anderson's Cancer Center, and will assist in the early detection of lung cancer in smokers and other high-risk populations. The test involves BioView-patented DNA markers that are scanned using BioView machines.
Following internal research to confirm the test's validity, BioView has recently begun clinical trials at several medical centers in Israel and the US to gather information that will be used in future applications to regulatory authorities.
Lung cancer is the cancer with the highest fatality rate in the world with more than 250,000 new diagnoses and more than 160,000 deaths every year in the US (according to the US National Cancer Institute). Non-small-cell lung carcinoma (NSCLC) accounts for 85% of all lung cancer cases.
According to market research commissioned by BioView, the test's market potential in the US, if the company's clinical trial is successful, is $80-200 million annually. This estimate is based on the assumption that the test will be covered by insurance companies in the US under Current Procedural Terminology (CPT) codes for Fluoresence in-situ Hybridization technique (FISH) scans. BioView believes that if the test's clinical trial and marketing are successful, it will be able to enter other market segments as well.
BioView CEO and president Dr. Alan Schwebel views this agreement as an important step towards the validation and final commercialization of the company's test. "Results from an initial internal clinical trial we conducted show that the test's performance is better than other non-invasive tests and methods for the early detection of lung cancer that currently exist and are known to the company."
BioView's share price was unchanged at NIS 2.02 today, giving a market cap of NIS 27 million.
Published by Globes [online], Israel business news - www.globes-online.com - on March 6, 2012
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