With low-dose CT screening for lung cancer, now may be the time for a California company’s smaller, possibly less expensive bronchoscopy technology.
The noise of revolution is deafening on the evening news, but there is a quiet revolution occurring in medicine that most have probably missed—a revolution in how we detect, diagnose, and treat lung disease, especially lung cancer.
The spark for this revolution came in 2010 with the posting of results of the NCI-sponsored National Lung Screening Trial (NLST) that compared low-dose helical CT scans with chest X-ray as screening test for lung cancer in a high-risk population (people with at least a 30 pack-year history of smoking). Suspicious lesions were found in the lungs of about a quarter (24.2%) of the people in the CT group compared with 6.9% in the chest X-ray group. But the ultimate measure of a screening test is whether it saves lives, and the NLST results showed a 20% reduction in death compared with the chest X-ray group.
Insurers are covering the CT screening tests. WellPoint was among the first when it said in December 2011 that it would pay for the scans. It took CMS much longer. The federal government announced in February of this year that Medicare would cover the scans.
But lost in all of the excitement (some might say hype) about having a reliable screening test for lung cancer is the number of people who need to be screened to save a life. In the NLST, 27,000 people were screened to prevent 62 deaths, which works out to about 2.3 lives saved for every 1,000 screened. Moreover, the CT scan is just a screening test. The lesions it finds must be followed up with a bronchoscopy. In the NLST, that meant roughly 6,500 bronchoscopies in the CT group, or about 240 bronchoscopies for every 1,000 people scanned.
The endoscopes currently for bronchoscopies were basically adapted from the scopes that revolutionized the diagnosis of colon cancer. The endoscope is 5.5 millimeters in diameter (about the size of a pencil eraser). It contains both a camera or fiber optic system for visualization of the airway and an operating channel that is about 3 millimeters in diameter and through which biopsies, brushings, and other procedures can be done, albeit in a limited fashion. A single bronchoscopy system costs, on average, about $100,000, and must be replaced every two or three years.
Bronchoscopy is a big business, and it is only going to get bigger with the advent of lung cancer screening. The market for all endoscopes is estimated at $28.2 billion and, by some estimates, is expected to grow by 34%, to $37.9 billion, by 2018. Since CMS’s coverage announcement, nearly 800 hospitals have gained certification as “lung screening centers” to meet the demand for the screening CT scans. Currently, the market for bronchoscopes is dominated by Olympus (about 80% of the market) with Pentax (15%) and Fuji (5%) a distant second and third.
The tip of Sanovas’s MicroCam bronchoscope is tiny. (Credit: Sanovas Inc.)
But Sanovas, a very small company taking on the giants, may soon disrupt this industry with an innovative product that is pending FDA approval by way of the 510(k) process. The scientists at the San Rafael, Calif., company have looked at bronchoscopy from an entirely different perspective. Their basic premise: The lungs are far different than the colon, so the instruments for examining the lungs need to be designed from scratch with that purpose in mind and not just adapted from the colon-inspecting variety of endoscope. They are also developing a whole “toolbox” of custom designed tools to use with their new system. The MicroCam bronchoscope that they engineered disassociates the camera from the operating channel, a major design change, and enlarges the channel to 6 millimeters. They knew that one complaint about the current generation of bronchoscope is the images can get blurry because the lungs are constantly moving. It’s rare, but physicians have been known to get vertigo during bronchoscopies. Sanovas ingeniously incorporated image stabilization software into the MicroCam system. The company also made it a “plug and play” device that can plug directly into a PC or smart device, so it is convenient to use and less expensive.
The Sanovas scope can accommodate a 3 millimeter camera, which is large by bronchoscopy standards. If a lesion is found, the camera can be swapped out and replaced with three different kinds of instruments. Each instrument has a camera, so the operator can use the tool and see the location in the lung where it is working at the same time.
Sanovas is racing to develop other associated devices specifically to take advantage of the MicroCam bronchoscope as a platform. They include a sensory-based catheter system that can measure spatial dimensions, such as diameter and density, and physiologic parameters, such as flow, temperature, and hemodynamic coordinates. Steerable biopsy needles and forceps can make sharp turns to retrieve specimens from the lung’s airways and penetrate the airway to sample lymph nodes. New brushes can increase cytology yields.
The multichannel bronchoscope also will allow the delivery of drugs (under direct observation) directly into small tumors, clotting factors into bleeding sites in the lung, and devices to “wall off” a part of the lung so a procedure can be performed on that segment of the lung while the rest of the lung is being ventilated to keep the patient alive. The company recently received a seminal patent on the local delivery of photodynamic therapy (PDT) to therapy-resistant tumors. As a side note, PDT, an old approach to killing tumors, is among the only therapeutic solutions known to achieve tumor kill in 100% of the patients.
But, as the late-night infomercials say, “That’s not all!” The cost of the new system is expected to start at about $10,000, with the entire toolbox costing only about a fifth of that of existing systems. This totally changes how these instruments can be deployed, and can significantly reduce the cost per procedure. Now, hospitals with smaller capital budgets can obtain a “scope kit” that can be used in many different ways. What’s more, because this new scope is so much easier to use and the learning curve is shorter due in part to the image stabilization, anesthesiologists, intensivists, and perhaps even internists may be able to perform bronchoscopy, thus allowing smaller hospitals to compete with the large academic centers where most of the care is now being rendered.
The NLST provided proof that low-dose CT scan screening of people at high risk for developing lung cancer can save lives. But the cost is rather high. Now Sanovas has come up with a plug-and-play device that may radically change the bronchoscopies that are needed after a CT scan finds a suspicious abnormality. The company’s technology holds out the promise of lowering cost and saving time. This author speculates that Sanovas’s system may also lead to an entirely new approach to lung cancer—local treatment with intralesional injections of chemotherapy and phototherapy in the distant airway. Treating lung cancer in this more targeted way might be especially helpful to frail and elderly patients who are not candidates for traditional chemotherapy and associated systemic toxicity.
The Sanovas revolutionary approach to direct lung visualization again demonstrates the scope of Tomorrow’s Medicine!