NEW YORK (GenomeWeb) -- Having suffered the loss last year of its exclusive US distributor Health Diagnostics Laboratory when that company filed for Chapter 11 bankruptcy, UK proteomic diagnostics firm Oncimmune is in the process of rebuilding US sales channels for its EarlyCDT-Lung cancer test.
Last September, Oncimmune reacquired the De Soto, Kansas-based CLIA lab it sold to HDL in 2013, and last month, it signed a deal with clinical lab Accu Reference for distribution of the EarlyCDT-Lung test. The company is also selling the test through True Health Diagnostics, a new clinical lab firm that purchased most of HDL's assets. Oncimmune CEO Geoffrey Hamilton-Fairley told GenomeWeb this week that the company plans to announce six to eight additional US distribution deals in the near future.
The EarlyCDT-Lung test measures levels of seven autoantibodies in patient blood to aid in the early detection of lung cancer. It is intended to be used in combination with CT scans, both as an aid for encouraging high risk patients to undergo CT scans and for helping physicians evaluate whether lung nodules detected on these scans are likely malignant or benign.
Oncimmune offers the test in the US, where it is covered by Medicare, and in the UK, where it is a patient-paid test offered out of private hospitals. Since fully rolling out EarlyCDT-Lung in 2012, the company has sold around 140,000 tests, a substantial number by the standards of new proteomic diagnostics.
The bulk of these sales were in the US, Hamilton-Fairley said, noting that unlike typical genomic and proteomic tests, many of which cost hundreds or thousands of dollars, the EarlyCDT-Lung test is positioned as a low-cost diagnostic. Medicare currently reimburses the test at $123, which is paid to the test's distributors, who then pay Oncimmune either a royalty.
Hamilton-Fairley declined to disclose revenue figures for the test, but documents filed as part of HDL's bankruptcy proceedings provide some insight. According to court filings, under HDL's license agreement for EarlyCDT-Lung, the company paid Oncimmune $25 per test performed. Over the last three years, Hamilton-Fairley said Oncimmune averaged around 40,000 tests per year sold in the US, which at $25 per test would come out to $1 million in US test revenues.
The license also called for HDL to pay Oncimmune annual minimum royalty payments beginning in 2014. The minimum payment was $1.625 million in 2014 and $3.25 million in 2015. It was set to rise to $4.875 million in 2016.
Prior to its bankruptcy, HDL was investigated by the US Department of Justice for allegedly paying doctors kickbacks to encourage them to order its tests. This civil investigation into HDL's practices, which ended with the company agreeing to pay the US Department of Justice roughly $50 million but not admitting any wrongdoing, focused mainly on HDL's cardiac testing business, but court documents indicate that the company similarly marketed EarlyCDT-Lung and that at least one doctor who received payments from HDL for ordering cardiac tests also ordered EarlyCDT-Lung.
This raises the question of whether sales of EarlyCDT-Lung under the HDL license agreement might have been inflated by HDL's practices. However, noting that Oncimmune "had nothing to do with how HDL sold the test," Hamilton-Fairley said that sales remained steady throughout HDL's bankruptcy and after HDL stopped paying doctors.
"It appears [the payments] had no influence" on EarlyCDT-Lung sales volume, he said, adding that "it is of some considerable encouragement to [Oncimmune] that without active sales support, sales continued at the same level, which shows physicians who had previously used the test recognized its value on its merits alone and continued using it on an ongoing basis."
Oncimmune markets EarlyCDT-Lung as a test in high-risk populations for two main purposes, assessing patient risk of lung cancer prior to CT screening and helping doctors evaluate pulmonary nodules picked up on a CT scan.
In the first case, the test can be helpful in encouraging high-risk patients to enroll in CT screening programs or in convincing insurers to cover CT screens for patients who are at elevated risk but don't fit current guidelines for CT screening, Hamilton-Fairley said. The test is not intended to rule patients out from having lung cancer, but rather to identify patients at increased lung cancer risk.
For instance, according to company data, an EarlyCDT-Lung result of low risk means a patient's one-year risk of lung cancer is unchanged, at around 1.2 percent. A result of moderate risk triples a patient's one-year risk, to 3.5 percent, and a result of high risk multiplies a patient's risk by roughly 16-fold, to 19.3 percent.
While according to current guidelines, all high-risk patients should undergo a CT scan, Hamilton-Fairley said the test's ability to identify patients at additional risk has proved useful for physicians to convince reluctant patients to have a scan.
Oncimmune is also preparing to publish on use of the test in evaluating nodules detected on a CT scan. In this area, the test is a competitor to Integrated Diagnostic's Xpresys Lung, which likewise is intended for helping physicians evaluate lung nodules. However, Hamilton-Fairley noted, while Xpresys is meant to rule out nodules as likely benign, EarlyCDT-Lung is meant to rule in nodules as likely cancerous.
"If you are positive on the test, there is a multiplication factor of risk on the nodules which physicians then use as a rationale to investigate more frequently, basically to do more frequent CT scans," he said. A positive result could also incline a doctor to intervene more aggressively if they see a nodule change in some way, he added.
Oncimmune has published several studies on the performance of the test, including a 2014 paper in the journal Lung Cancer in which researchers looked at the outcomes of 1,613 patients at high risk for lung cancer whose physicians had ordered the EarlyCDT-Lung test. In that study, 61 patients were identified in follow up with lung cancer, 25 of whom had received positive EarlyCDT scores, giving the test a sensitivity of 41 percent. The study also found that a positive score indicated a 5.4-fold increase in lung cancer incidence.
The company is also involved in a 12,000 patient trial run by the National Health Service Scotland. In initial results presented last year, looking at the first 8,848 patients enrolled, 9 percent of those tested had a positive blood test, with eight early cancers detected along with 13 abnormalities that are receiving additional investigation. Of the eight cancers detected, six were staged and four of those were early stage.
Hamilton-Fairley said that early data from the study also showed that use of the test shifted the stage in which the cancers were detected to around 80 percent stage I and II, up from around 30 percent detected in stage I and II using standard clinical practice. This, he noted, was a potentially significant finding, given that health economic studies have shown that in the UK, detection of lung cancer in stage I and II saves around £45,000 ($64,000) per patient in treatment costs.
He said Oncimmune hopes to use the study data to win NHS coverage of the test in the UK, as well as to aid in US reimbursement and, potentially, a future US Food and Drug Administration submission.
Oncimmune's autoantibody-based approach is somewhat different from conventional protein biomarker assays. Rather than looking at proteins that are, for instance, shed from cancer cells, the company looks at antibodies generated in response to these proteins. This is potentially advantageous because immune cell replication involved in the immune response provides a natural amplification of the antibody signal, making it possible to detect disease earlier than with conventional protein markers.
The company is not alone in pursuing such an approach. For instance, firms like Arizona State University spinout HealthTell and German diagnostics firm Protagen both use antibody markers. While these firms use large protein arrays to detect antibody signatures indicative of certain diseases, however, Oncimmune screens smaller sets — typically around 100 to 200 antigens — of cancer-related proteins that it identified via literature searches.
"We actually do very little discovery per se, because there is a massive amount of published work," Hamilton-Fairley said. "We go into the literature to see which antigens are relevant to which cancer, and then we have a high-throughput platform that allows us to screen which ones work best, and then we have to make sure we can produce those on a commercial scale, and once we have done that, we do final selection and validation."
Based on technology spun out of the University of Nottingham, Oncimmune currently has 28 employees and is privately funded through angel investors and one venture capital group that have invested around £33 million to date, Hamilton-Fairley said.
In addition to EarlyCDT-Lung, the company is working on antibody-based tests for liver and ovarian cancer.