NEW YORK (GenomeWeb) – German biomarker firm Sphingotec plans this year to launch its protein-based test for breast cancer risk prediction in the US.
The company will offer the test, which measures levels of the proteins proneurotensin (pro-NT) and proenkephalin (pro-ENK) to predict medium-term breast cancer risk in healthy women, through clinical reference lab Innovative Diagnostic Laboratory beginning in December, Karla Gonye, president of the company's US subsidiary, told GenomeWeb.
The company launched the test inEuropelast year, where it is CE marked and offered out of several different clinical reference labs, Gonye said. The company's business model, she noted, is to commercialize its tests through licensing agreements with clinical labs and IVD testing companies, focusing its efforts primarily on research and development of the markers.
Sphingotec was founded in 2002 by its CEO Andreas Bergmann, formerly a founder and chief research officer of biomarker firm B.R.A.H.M.S., which commercialized a number of protein markers including the sepsis marker procalcitonin and was purchased by Thermo Fisher in 2009 for $470 million.
The company, which is privately funded and has roughly 30 employees, is divided into two areas, Gonye said, one focused on markers for acute disease such as kidney injury and the other focused on longer-term risk prediction in areas including breast cancer and cardiovascular disease.
The breast cancer assay is currently the main focus of this latter division, Gonye said, noting that the company aims to position it as filling a currently unmet need for non-genetic breast cancer risk markers.
"Breast cancer is one of those areas where we have realized there is really nothing [non-genetic] in terms of risk prediction," she said. "BRCA is a great breakthrough for understanding genetic risk, but breast cancer due to hereditary cause only represents around 5 to 10 percent of cases."
The company and collaborating researchers identified and validated the markers through a series of studies beginning with a study published in the Journal of the American Medical Association in 2012 that identified plasma pro-NT levels as linked to breast cancer. That study examined pro-NT levels in 4,632 participants of the Malmö Diet and Cancer Study. It also linked pro-NT levels to increased risk of diabetes and cardiovascular disease.
In a 2014 study in Cancer Epidemiology, Biomarkers & Prevention, the researchers validated their findings in a second cohort, this time looking at 1,569 participants of the Malmö Preventive Project, an 18,240-subject population study. That work likewise found that pro-NT levels were significantly related to the incidence of breast cancer.
Last month company researchers published their findings on pro-ENK in the Journal of Clinical Oncology, which they tested in the same two cohorts as pro-NT. They found a link between pro-ENK levels and breast cancer in both the 1,929-sample cohort from the Malmö Diet and Cancer study and the 1,569-sample group from the Malmö Preventive Project.
As offered commercially, the test provides an assessment of breast cancer risk over a period of either five to seven years (for patients between 63 and 73 years old) or 10 years (for patients between 53 and 63 years old), Gonye said. According to the company, patients with abnormally high (in the case of pro-NT) and low (in the case of pro-ENK) marker levels have nine times the risk of developing breast cancer over these time periods compared to women with normal marker levels.
Sphingotec has taken the test to market based on these three studies, but the company continues to gather evidence for its performance, Gonye said, including a study using a cohort of roughly 4,000 patients from the National Heart, Lung, and Blood Institute's Women's Health Initiative study and participation in a prospective trial led by University of California, San Francisco researcher Laura Esserman.
"We are confident with the data but we are continuing with the research," she said, adding that the company has thus far tested the markers mainly in a European population and would now like to investigate them in a more diverse mix of ethnicities.
Both pro-NT and pro-ENK are linked to lifestyle factors like diet and exercise and so are amenable to interventions affecting these factors, Gonye said.
"The good news is, unlike your genetics, you can change [these markers] because they are more related to stress, fat, and other lifestyle factors," she said, citing increased exercise regimens or increased mammograms as examples of interventions that might be recommended for patients identified as being at high risk based on their pro-NT and pro-ENK levels.
In keeping with its business model of focusing on marker research and development as opposed to commercial implementation, Sphingotec has no plans to take its breast cancer markers through US Food and Drug Administration clearance. On the contrary, Gonye said, requests from several companies that the firm do so have proved a deal-breaker.
"Some labs have told us they would love to have our test but that they would like it to go through FDA, and we have walked away because it is not our intent to develop components and sell kits," she said.
While the breast cancer markers are the company's current focus, Sphingotec is also working on tests for several other indications including kidney failure and cardiovascular disease. It is in the process of getting pro-ENK CE marked as a biomarker for acute kidney failure, which, Gonye said, is the firm's next area of focus.
Sphingotec is developing both pro-ENK and the peptide bio-adrenomedullin (bio-ADM) as markers for acute kidney injury. Gonye said the company has data on these markers in around 20,000 patients along with comparison data against a range of current kidney biomarkers including Astute Medical's Nephrocheck test for AKI.
For its tests focused on the acute disease setting, Sphingotec is targeting as potential licensees large IVD companies with automated platforms, Gonye said.
"We're talking to every major company with an automated platform and there is very significant interest" in the kidney markers, she said.