GeneNews (TSX:GEN) is addressing the major issue in early cancer screening - patient reluctance with inconvenient and intrusive screening methods - with a suite of differentiated molecular diagnostic tests that rely on a convenient in-office blood draw to find cancers of the colon, lung, breast and prostate, early.
“If patients will not undergo screening because of the test, it severely limits the usefulness,” chairman and CEO, James Howard-Tripp, says in an interview with BioTuesdays.
“And because there is this compliance gap, healthcare providers are actively seeking ways to improve cancer screening and improve patient outcomes.”
For example, he points out that the American Cancer Society has set an “80-by-18” goal for healthcare providers to have 80% of their qualified patient population screened for colorectal cancer by 2018. “Today, less than 59% of patients have met this goal,” he says, adding that colorectal cancer is highly preventable when detected early.
In lung cancer, he says that among smokers, nine million Americans who smoked the equivalent of one pack per day for 30 years, for example, fall into an eligible group for annual low dose CT scans for early detection.
However, current lung cancer screening rates are in their infancy at less than 1% because people are hesitant to receive radiation and must travel to sites offering CT scans. When detected early, however, lung cancer survival rates can triple.
And in breast cancer, mammograms of dense breast tissue miss some 50% of tumors, he suggests. “It’s described as looking for a snowball in a snow storm.”
GeneNews’ comprehensive menu of evidence-based blood tests that aid in cancer risk stratification include ColonSentry, the only molecular blood test to screen for colon cancer; EarlyCDT-Lung, whose key advantage is an ability to help detect risk of lung cancer up to two years earlier and with a higher specificity than CT scans; and the Prostate Health Index (PHI), which helps differentiate prostate cancer from benign prostatic conditions.
PHI is used in men with elevated PSA to determine if a prostate biopsy is required. The test measures three different types of PSA and is a more accurate way to asses cancer risk than PSA and percent-free PSA alone. The survival rate for prostate cancer is nearly 100% if detected early.
In the first quarter next year, GeneNews plans to begin offering BreastSentry, a single test comprised of two biomarkers, pro-NT and pro-ENK, together with a sophisticated algorithm, that will estimate a woman's five-year risk of developing breast cancer.
This is very much in line with Vice President Joe Biden’s Cancer Moonshot goals of transforming cancer research by accelerating development of safe and effective blood profiling diagnostic technologies, among other things, Mr. Howard-Tripp points out.
GeneNews’ molecular tests are processed at its Innovative Diagnostics Laboratory (IDL), in Richmond, Va., which is certified by the College of American Pathologists and Clinical Laboratory Improvement Amendments. IDL has performed more than 300,000 tests since its inception and has the capacity to service all of the U.S.
The ColonSentry technology, which measures the expression of seven gene biomarkers in blood, was developed in-house by GeneNews. For its other molecular tests, the company has partnered with Britain’s Oncimunne, Beckman Coulter of the U.S. and Germany’s sphingotec GmbH.
Mr. Howard-Tripp says that with colorectal cancer, even though payers have put incentives in place to aid physicians in boosting compliance, “they haven’t been able to move the compliance needle because colonoscopy is inconvenient and patients very much dislike performing stool samples.”
The ColonSentry test is designed to drive more of the right people to have colonoscopy, he explains, because the true diagnostic for colorectal cancer is a biopsy obtained during colonoscopy.
“Risk stratification data from a test like ours, plus colonoscopy, indicates that you are 2.7 times to 4.1 times more likely to find the cancer,” he contends. That’s important because colonoscopy misses on average 50% of right side tumors, and 25% of aggressive cancer can occur within two years of having a clean colonoscopy.
“We are aiming at the 30% to 50% of the at-risk population that will not get screened through other modalities, thereby increasing compliance, and getting people into the treatment cycle as early as possible,” he adds.
According to Mr. Howard-Tripp, the company’s EarlyCDT-Lung test can find lung cancer up to two years earlier than low dose CT scan, making the disease very treatable. “This is backed up by a 12,000-patient study just concluding in the UK, which showed that when we say lung cancer is present, eight out of 10 times we are correct.”
In addition, there is a high percentage of false-positive lung biopsies coming out of positive readings from low dose CT scans. “Our EarlyCDT-Lung test can help triangulate this, which should translate into savings for the healthcare system,” he adds.
EarlyCDT-Lung measures seven autoantibodies in moderate-to-high risk patients in a convenient blood test. These autoantibodies are produced in response to growth of cancer cells in the lung.
Mr. Howard-Tripp says the market is keenly interested in BreastSentry test for breast cancer set for release in the first quarter. The initial target for BreastSentry is women that have dense breast tissue, which includes some 40% of women, where mammograms are less effective in detecting cancer, he suggests.
“Our objective is to reduce the number of late-stage cancers within our target markets and reduce the costs of finding them with state-of-the-art diagnostics for the benefit of patients and the healthcare system,” he adds. “In other words, fixing the compliance gap.”
In order to broaden the reach of its molecular tests, GeneNews has joined forces with JTS Healthcare Partners, a leading healthcare management consulting and professional services firm focused on meeting the needs of the nation’s many top healthcare organizations in both the private and public sectors.
Mr. Howard-Tripp says the GeneNews-JTS venture is targeting large accountable care organizations; integrated hospital networks and hospital systems that employ physicians; integrated clinical networks; large group practices; cancer centers; and self-funded employers.
“We are now dealing with $1-billion to $5-billion healthcare systems that face the screening issues we have outlined and the intent is to narrow the compliance gap with state-of-the-art science,” he points out. “And by impacting compliance, not only can we help reduce costs in the system, but increase revenue by bringing new patients into the system. It's a win-win.”
In September, the venture partnered with NueHealth, a privately-owned company that delivers value-based healthcare solutions and connects patients directly to physicians through integrated provider networks (IPNs), as well as self-funded employers and tele-health.
Mr. Howard-Tripp explains that patient testing will be done at NueHealth centers and samples processed at the IDL lab. “Our diagnostic services will be provided via a flat-fee model, with NueHealth responsible for managing client billing within its value-based healthcare solution model.”
GeneNews has begun the process of introducing its diagnostics to NueHealth physicians within IPNs as well as self-funded employers. Two early-adopter sites in Pennsylvania have been selected for training and process validation is being completed.
The two companies also are in discussions with multiple, large healthcare systems about adopting GeneNews' early cancer screening diagnostics into their hospitals and IPNS.
“We also are being offered more blood-based, state-of-the-art molecular tests,” Mr. Howard-Tripp says, adding that the company has two bladder cancer tests on the table, which are urine-based, but “that’s likely to be the only time we move away from blood-based testing.”