Perceptronix (Vancouver, British Columbia) presented results of a new study that indicates that buccal mucosa, or cells scraped from the inner part of the cheek, may contain information that separates patients with lung cancer from high-risk negatives.

If it eventually passes regulatory hurdles in Canada, where it is expected to be presented next spring, it could mean that high-risk patients could simply go to a primary care physician's office to get the test, rather than undergoing diagnostic imaging, which if repeated over time can carry its own risks.

The research was presented at CHEST 2005, the 71st annual international scientific assembly of the American College of Chest Physicians (ACCP; Northbrook, Illinois), in Montreal.

Bojana Turic, MD, director of clinical and regulatory affairs for Perceptronix, told Diagnostics & Imaging Week from the conference on Wednesday that the company's goal was "to try technologies with a number of people to get some of this interesting research through the regulatory bodies so that it can actually be used in clinical practice."

She added, "Now, whether this one will finish its journey, I don't know ..."

Perceptronix was founded in June 1999 as a spin-off from the British Columbia Cancer Agency (BCCA; Vancouver) with the express purpose of developing early cancer detection methods, she said. It was from BCCA that the idea for using both the buccal mucosa cells and another test, a sputum test, for detecting lung cancer originated.

A clinical test based on buccal cells is still in development, but the research definitely showed that researchers were able to get a signal indicating lung cancer in its study.

Turic and colleagues analyzed random cheek scrapings of 150 confirmed lung cancer patients and 990 high-risk patients, using automated quantitative cytometry (AQC). Able to detect subtle chances in buccal cell nuclei, the AQC system analyzes several thousand cells per specimen and reduces the data to a single score that predicts the likelihood of the presence of cancer.

Of the buccal specimens collected, the AQC showed 66% sensitivity at 70% specificity overall, and 61% specificity for Stage I lung cancer, which comprised 47 of the 150 cases.

Turic told D&IW she was not surprised by the results.

"Stage I lung cancer is considered treatable, but lung cancers are currently detected beyond Stage I," Turic said in a news release. "We believe that early detection is the key to reducing lung cancer mortality and have focused our approach around detecting Stage I lung cancer."

Perceptronix said that although the test is not intended for screening the general population – currently only high-risk patients – the researchers are hopeful that the AQC method will become an accurate, non-invasive, inexpensive and easy-to-administer lung cancer detection test for patients at risk for lung cancer.

"A sufficient mount of cells can be collected by scraping the inside of the cheek with a small wooden spatula similar to a tongue depressor," said Turic. "Ultimately, the test could be administered in primary care settings or dental offices. The procedure is simple enough that specimen collection could be done by patients themselves."

The company also has developed a sputum test, already named ClearSign, that uses the AQC method. Perceptronix hopes to receive Canadian regulatory approval in early 2006. Both tests are intended to provide pulmonary physicians with valuable information to help them manage patients at risk of developing or suspected of having lung cancer.

"We think it's really interesting," she said. "First of all, we think it's interesting because we could detect the signal in the buccal, [although] it was weaker than in the sputum [test]," she said.

In doing the tests, the company's primary goal was to gain the results necessary to get regulatory approval for the sputum test, but it went ahead and "tried to detect the same phenomenon in buccal scrapings," Turic said.

Not that much work remains to be done before Perceptronix goes before regulators with the buccal mucosa test, probably in late spring of 2006, she said.

"When you are doing a diagnostic test, the follow-up information is also interesting, so we have to wait for these follow-ups," Turic said.

However, she cautioned, "We need to investigate a few more things, [so] I really don't know when or if it will be available as a clinical test."