NEW YORK (GenomeWeb) – Since quietly releasing its SimpliPro Colon proteomic colon cancer test at the end of 2015, Applied Proteomics has seen encouraging reorder rates and coverage decisions, company officials told GenomeWeb this week.
The test is intended for assessing the risk of advanced adenoma or colorectal cancer in symptomatic patients with a primary focus on increasing patient compliance with recommended colonoscopies, the gold standard for diagnosing these conditions.
As such, the test is aimed not so much at changing physician decisions as at providing doctors with another piece of evidence they can use to convince symptomatic patients to undergo a colonoscopy.
The test measures the levels of 11 proteins in blood and returns a score that indicates whether a symptomatic patient has a low or high risk of advanced adenoma or CRC. According to company data, the test detects advanced adenoma with 45 percent sensitivity and 80 percent specificity; stage I and II CRC with 75 percent sensitivity and 78 percent specificity; and stage III and IV CRC with 88 percent sensitivity and 78 percent specificity.
Even in cases where the test indicates patients are at low risk, however, they are still by virtue of their symptoms (which can include things like gas, abnormal bowel movements, and abnormal weight loss) at significantly higher risk than asymptomatic patients, said Premal Shah, API's vice president, strategic marketing and corporate development.
And, Shah noted, "Everyone with an elevated risk should go get a colonoscopy," meaning that the test is not intended to either rule out or rule in the need for that procedure.
Shah added that roughly fifty percent of the symptomatic population for whom a colonoscopy is recommended do not undergo one in a timely fashion. The SimpliPro test "offers the physician yet more information and more detail to talk to the patient and encourage them to get a colonoscopy," he said.
According to numbers from the US Centers for Disease Control and Prevention, colonoscopies have a 62 percent compliance rate, though Shah noted that this number is a blended average that includes both symptomatic and asymptomatic patients.
Given that the SimpliPro test is not designed to influence physician treatment decisions, it might seem more a motivational tool than a molecular diagnostic. Shah suggested, however, that such a characterization trivializes the significance of the patient compliance problem it is meant to tackle.
"What the primary care physician wants to do [with a symptomatic patient] is get this person to the gastroenterologist to get a colonoscopy," he said. "Now, the reality is, many, many people annually don't go get that colonoscopy right away. Of the 10 million [symptomatic patients annually], we estimate roughly 5 million need a non-invasive test first to get them over the hump to go see the GI."
API CEO Peter Klemm said that early sales of the test, which lists for $448, have been encouraging, noting that the company has seen reorders from a number of physicians. Shah added that while the company currently has a coverage agreement with only one small payor, a number of insurers have paid for submitted tests, though he declined to provide numbers on the rate at which tests were being reimbursed.
The company has launched sales nationally (with the exception of New York state where it is still working to achieve regulatory compliance), targeting primary care physicians. It offers the test on an ELISA-based platform out of its CLIA lab.
The current version of the SimpliPro Colon test differs significantly from API's original test plans. Initially, the company was interested in developing a screening test for identifying patients at high risk of having CRC or colon polyps with the idea that this would encourage these patients to undergo recommended colonoscopies.
Klemm said that a screening test was still a possibility down the road but that currently the company's focus was on developing and commercializing this version of SimpliPro.
One point to consider when weighing the market potential of a test for symptomatic patients as opposed to a general screening test, Shah argued, is that while the estimated customer base for a screening test is very large — around 30 million to 40 million people — this does not reflect the actual annual opportunity.
"When you do a screening colonoscopy and you come back negative, you are off the grid for five to 10 years," he said. "So, you should actually divide that [potential customer base] by the frequency of the test."
Another change is the company's shift from mass spectrometry to ELISA as its clinical platform. Launched in 2007 by David Agus, director of the University of Southern California's Center for Applied Molecular Medicine, and Danny Hillis, chairman and co-founder of technology firm Applied Minds, API has made much of Hillis' and Applied Minds' technical expertise and the role it has played in aiding development of a high-performing, highly reproducible mass spec-based biomarker discovery system.
After initially planning to move its markers from mass spec to an immunoassay format for commercialization, API changed course, announcing in 2013 that it would instead use multiple-reaction monitoring mass spec for its assays. With the launch of SimpliPro, though, it is back to its original plan, a decision that the company has said stemmed from a desire to go to market as early as possible and the fact that the test's 11-protein panel was smaller than they expected, thus reducing the anticipated multiplexing benefits of mass spec.
Klemm said this week that API is currently at work on a second-generation product that could use an expanded panel of proteins, in which case it might be desirable to move to a mass spec format. But, he said, "Right now we are very confident of this first version of the product on the ELISA platform."
With its test in the marketplace, API is now working on additional validation studies as well as studies looking at health and economic outcomes, Klemm said. "We are increasing our clinical validation evidence as well as building the utility study evidence needed for broad adoption."