PHD Diagnostics, and its clinical lab division, Molecular Diagnostics Laboratories , have developed the first gene-based test, Respiragene™, that identifies smokers and ex-smokers at greatest risk of developing lung cancer,  compared to other smokers.

More people die from lung cancer in the U.S. than any other type of cancer.  Lung cancer accounted for 160,390 deaths in 2007, more deaths than from breast cancer, prostate cancer and colon cancer combined.  Mortality rates remain stubbornly high because of the lack of early detection tools and low response rates from chemotherapy.

Quitting smoking can lower lung cancer risk, along with the risk of dying from heart attack, Chronic Obstructive Pulmonary Disease (COPD), emphysema, stroke and many other smoking-related diseases 

Unfortunately many smokers struggle to quit.  Research suggests smokers often suffer from “optimistic bias” – the belief that bad outcomes happen to other people, not them.  Respiragene™ gives doctors a tool to help engage smokers and counter this optimistic bias by personalizing the health risks of smoking, before complications develop. In a 1999 study published in Nicotine & Tobacco Research, more than 80 percent of smokers and ex-smokers reported that they wanted to know their own risk of developing lung cancer. 

“For the first time you can learn your individual level of lung cancer risk compared to other smokers,” said Bob Walker, the president of PHD Diagnostics. The molecular lab specializes in molecular diagnostic test development and processing and is part of bioLOGIC, a global life science accelerator   based in Covington.  

“Respiragene™ provides an easy to understand score and personalized information that doctors and patients can use to help individuals take the steps required to quit smoking and improve their overall health,” said Walker.

Identifying higher-risk patients may also help doctors better identify those who should be more closely monitored for early symptoms or signs of lung cancer, as part of an overall effort to diagnose lung cancer early and improve survival rates for those who do develop the disease.  Fewer than 50 percent of individuals diagnosed with lung cancer live longer than one year from their first diagnosis, often because the cancer is discovered too late to be effectively treated.

The Respiragene™ test generates a score that places chronic smokers and ex-smokers in three categories.  A "Moderate Risk” score means the person has a risk of developing lung cancer comparable to an average smoker.  Average smokers are 20 to 30 times more likely to develop lung cancer than non-smokers, and about one in 10 will develop lung cancer. 

Those with “High Risk” scores are about four times more likely than those at “Moderate Risk” to get lung cancer, and those at “Very High Risk” are about 10 times more likely to get the disease.  Studies show that approximately 30 percent of individuals fall into the high risk and 20 percent into the very high risk groups.

Taking the Respiragene™ test is as simple as brushing your teeth.  After receiving medical authorization for the test from a doctor, a swab is rubbed against the cheek inside the mouth to collect a small cell sample.  The swab is shipped to MDL where its highly-trained technicians extract DNA from the cells and analyze specific genetic markers called single nucleotide polymorphisms (SNPs).  They combine this information with non-genetic risk factors for the disease to produce a personalized risk score.

The Respiragene™ technology is based on a long-term genetic research program and ongoing clinical studies led by Dr. Robert Young, an Associate Professor in the Schools of Medicine and Biological Sciences at the University of Auckland in New Zealand and Chief Scientific Officer for Synergenz BioScience Ltd., a company spun off from the University. PHD Diagnostics licensed the technology and developed the Respiragene™ test specifically for the U.S. market.

"About 50% of those who get lung cancer have already quit smoking, indicating that many ex-smokers remain at risk of lung cancer, despite having broken their habit in the past,” said Dr Young. “This is particularly the case for those who have smoked for over 30 years and quit within the last ten years or who have left quitting until after 60 years of age. Identifying these people at high residual risk despite quitting may also increase awareness and maintain resolve to remain abstinent.”

MDL will process Respiragene™ tests from across the U.S. and abroad in its state-of-the-art CLIA-certified laboratory facility in Covington, KY. CLIA stands for Clinical Laboratory Improvement Amendments, the national regulatory framework for medical laboratories.  The test can be ordered by logging on to www.respiragene.com, sending an email to info@respiragene.com or calling MDL at 513-437-3000.

About PHD diagnostics and bioLOGIC

bioLOGIC, founded in 2006 is a global life science accelerator offering management, technical, and regulatory services expediting commercialization of life science ideas. The company is headquartered in Covington, KY with affiliates in Shanghai, China, Ft. Collins, CO and Melbourne, Australia.

About Synergenz

Synergenz BioScience Ltd was formed in 2004 to commercialize respiratory risk assessment technologies first discovered by Dr. Robert Young in research conducted at the University of Auckland in New Zealand, where research continues in collaboration with leading academic and commercial partners around the world. Website:  www.synergenz.com

For more information contact:

Margaret van Gilse

bioLOGIC

513-833-7065

mvangilse@fuse.net

Ken Li

Synergenz

312.997.2436 x 112 (w)

312.375.1157 (m)

media@respiragene.com

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