NEW YORK (GenomeWeb) – Swiss diagnostics firm ProteoMedix aims to launch its proteomic prostate cancer diagnostic within the next 18 months, CFO Christian Bruehlmann told Genomeweb this week.
The company recently completed several clinical studies and closed a CHF 5 million ($5.2 million) financing round to support commercialization of the test, which is intended as an aid for diagnosing prostate cancer in cases where current conventional measures are equivocal.
ProteoMedix has almost finished converting the test to the final immunoassay format and will now focus on obtaining the CE IVD mark and setting up kit production, Bruehlmann said. He added that the company will launch the test in Europe first and then evaluate its options for expansion, including potentially into the US.
The test is intended for use in patients with a total PSA value of between 2 and 10 nanograms per ml, a negative digital rectal examination, and an enlarged prostate volume. This particular set of patients is one of the most difficult for physicians to diagnose, he said.
The indicated PSA range, while elevated, is not conclusive, he noted, and while an enlarged prostate volume can be caused by prostate cancer, it can also stem from a variety of benign conditions. Additionally, urologists will typically order a biopsy for patients with a positive digital rectal exam, but in these cases the DREs are negative.
"It is very difficult for a urologist to determine what to do with this subgroup, and our test targets specifically this subgroup," Bruehlmann said. He added that there are around 2.8 million patients in this subgroup globally each year, and that this number is growing as the population ages.
The ProteoMedix test uses measures of four proteins along with a patient's PSA score to gauge the likelihood of a patient having prostate cancer. In a 143-patient study published in Proceedings of the National Academy of Sciences in 2011 that is the basis for the test, the four-protein panel detected prostate cancer with an accuracy of 84 percent, compared to 70 percent for PSA alone, and offered specificity of 79 percent compared to 45 percent for PSA alone.
More recently, results from a 500-patient clinical study the company completed this spring indicated that the test could prevent up to 60 percent of unnecessary biopsies in its intended use population, Bruehlmann said.
ProteoMedix initially hoped to launch the test in 2015 but delayed those plans in order to run additional clinical studies, including a prospective trial in the US, CEO Ralph Schiess told GenomeWeb in a 2015 interview.
Since then, however, the company has pulled back from its US aims. While "it is possible we will run a US study in the next two or three years," no firm plans are currently in place, Bruehlmann said.
In addition to preparing the diagnostic test for launch, ProteoMedix is developing a prognostic test to help assess the aggressiveness of patients' prostate cancers. Overtreatment is an issue for prostate cancer care, as many such cancers are slow-growing and do not require significant immediate treatment.
The difficulty of distinguishing between aggressive and indolent disease, however, means that many patients are given treatments that are likely unnecessary.
"There is a certain tendency toward overtreatment," Bruehlmann said. "If someone is diagnosed, the next logical step is a prostatectomy and sometimes even do radiotherapy, and it is not always necessary."
ProteoMedix is participating in a research project focused on the development of such a test funded by CHF 1.6 million from Switzerland's Commission for Technology and Innovation, and has identified a marker panel that it is now working to validate.
For its discovery work, the company uses a glycoprotein-enrichment technique developed in the lab of Swiss Federal Institute of Technology researcher Ruedi Aebersold, who founded ProteoMedix with colleagues as a spinout of the institute in 2010.
The enrichment step enhances the sensitivity of mass spec discovery, allowing the researchers to quantify proteins present in the nanogram per mL range, the concentration at which many clinically useful biomarkers exist in serum. Restricting the search to glycoproteins means they are potentially missing some candidate markers. However, roughly 80 percent of protein biomarkers currently in clinical use are glycoproteins, making this a promising fraction of the proteome to search in.
In the case of both tests, ProteoMedix will be entering rather crowded fields, as a number of molecular testing firms have products aimed at diagnosing and prognosing prostate cancer.
Companies including Genomic Health, Myriad Genetics, GenomeDx, Opko Health, and Metamark all have genomic or proteomic tests on the market for gauging the aggressiveness of a patient's disease.