NEWS

Biomarkers Advance Early Lung Cancer Detection

Lou Fintor

The race to diagnose lung malignancies with more precision and potentially minimizing the need for invasive biopsies and more extensive workups received a boost recently with the approval of a new imaging test and also the results of a pilot study involving a simple blood test.

NeoTect, manufactured by the New Hampshire-based company Diatide, Inc., is a peptide-based radioactively-labeled imaging agent that binds to somatostin receptors on cancer cells. The test kit received U.S. Food and Drug Administration approval in August and will be available to physicians for approximately $500.

"It's a major advance," said Florence Houn, M.D, director of the FDA's Office of Drug Evaluation III, adding that its novelty lies in the ability to detect the biological function of malignancies. "As an adjunct to existing diagnostic tools, NeoTect tries to identify and further categorize patients that should go on to biopsies in a minimally invasive way."

Early lung cancers are often asymptomatic and chest x-rays or other radiological techniques can sometimes be useful for identifying suspicious abnormalities, but require a biopsy for more definitive diagnosis. Invasive diagnostic procedures such as exploratory thoracotomy and fine needle aspiration biopsies are inconvenient and carry risks, however small.

Important advantages of the test kit may be cost and accessibility. Using Positron Emission Tomography in the diagnosis of lung cancer costs approximately $2,000 per scan and it is not widely available, whereas Diatide, Inc. expects its $500 kits to be reimbursable by most insurers and available to nuclear medicine facilities as of the middle of last month.

According to John Lister-James, Ph.D., Diatide's vice president for science and technology, NeoTect is not a "stand alone" cancer test, but it can be useful in better determining appropriate candidates for more invasive diagnostic procedures.

When used in conjunction with chest x-ray and CT scanning, NeoTect may result in a savings of more than $50 million annually in the United States, according to Hirsch Handmaker, M.D., president, Healthcare Technology Group of Phoenix, Ariz., and a NeoTect clinical trial investigator.



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Dr. Hirsch Handmaker

 
NeoTect can be especially useful in distinguishing possible malignancies among populations where lung abnormalities associated with coccidiomycosis, San Joaquin Valley Fever, histoplasmosis, and tuberculosis may result in a high rate of suspicious chest x-rays and other diagnostic tests, Handmaker said.

Meanwhile, because at least one potential factor in successful treatment is earlier detection, the results of a recent pilot study measuring serum levels of the enzyme telomerase hold hope for a simple, inexpensive, accessible blood test.

In the study, investigators at the University of Maryland School of Medicine and Cancer Center in Baltimore evaluated telomerase activity in 20 lung cancer patients: six participants with markedly elevated blood levels of telomerase had advancing disease, while 13 of 14 who had no significantly detectable elevation, were found to be in remission.

Although the results are preliminary, said study investigator Judith Stanberg, Ph.D., an associate professor of pathology, "this may turn out to be an exciting, useful and non-invasive test for following lung cancer."



             
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