A straw, a bag and a microchip may be the future of lung cancer screening.
A startup in Louisville, Kentucky, is working on a method that would make it easy enough and cheap enough to establish a national screening program. A patient breathes into the bag. The bag is sealed and sent to a lab. The air from the bag is released over the VitaLung microchip that detects certain biomarkers in the volatile organic compounds of a person’s breath.
“The results are compared with the biomarker pattern linked to lung cancer and then we can make a determination about whether or not the person has lung cancer,” said Bayard Donaldson, the chief executive officer of VOC Diagnostics.
The team got grant money to develop the micropreconcentrator on the chip from The Bill & Melinda Gates Foundation, the University of Louisville and the National Science Foundation.
VOC Diagnostics found the technology on the University of Louisville’s tech transfer site. The company has an option to license the technology from the university that covers the chip and the biomarker pattern of lung cancer.
Currently, the company is doing human efficacy trials at the University of Louisville and recruiting participants from the James Graham Brown Cancer Center. Early results show an accuracy of over 90 percent and a false positive rate of less than 10 percent.
“We feel like we have the data right now to enter formal meetings with the FDA (U.S. Food and Drug Administration), but we want more,” he said. “One hundred twenty is statistically relevant, but we would like to get to 200 patients.”
Low-dose CT scans are the current standard for screening for lung cancer. A Milliman study of this method concluded that offering LDCT screening as an insurance benefit would save lives at a low cost compared to routine screenings for other cancers. Milliman also conducted a survey of their Oncology Roundtable members in March 2012 and found that about 32 percent were using CT scans to screen for lung cancer. Among the respondents that did not offer lung CT screening, 77 percent were considering adding the service.
Although LDCT scans are better than X-rays at detecting lung cancer, there is still a high rate of false positives. Also, smokers at a high risk of lung cancer would be exposed to radiation frequently and might have to cover the $300 scan out-of-pocket.
Donaldson said that the VitaLung test is cheaper, safer and more accurate.
“Our test is less expensive to administer, there’s no radiation risk, and it’s easier to distribute because you can just mail it in,” he said. “We see so many advantages from a cost perspective and an early diagnosis.”
Donaldson said the National Comprehensive Cancer Network has endorsed a national screening plan for lung cancer and that there is national momentum behind the idea. The goal is to make the VitaLung test goal a standard component of the exams of people at high risk for lung cancer.
“It’s not even the most common cancer, but it kills so many more people because we haven’t gotten early diagnosis figured out,” Donaldson said. “You have a long window to catch it, but we’re just not doing it.”
Donaldson and the other members of the VOC team are in the MBA program at the University of Louisville. Donaldson’s background is finance. Another member of the team worked for Humana and has experience with mergers and acquisitions as well as diagnostics and medical devices.
Donaldson said that the team uses a dog in its pitch to introduce the idea of detecting VOCs. Several studies have shown that dogs can detect lung cancer by smelling a person’s breath.
“We say we wouldn’t be here without the dog,” he said.
Adding a warm-and-fuzzy element to the serious subject of lung cancer must work for VOC. The team participated in two business plan contests in February. They won second place and $5,000 at a Louisville competition. The group won first place and $10,000 at a business plan competition at the University of Cincinnati.
This study is important support to show the benefits of early screening for lung cancer. Also important is ensuring that screening is done right. http://bit.ly/12bX1ID
Less than 1% of cancer biomarker candidates actually end up as FDA approved lab tests. Unfortunately, there's many a slip between the cup and the lip.