NEW YORK (360Dx) – Australian proteomics firm Proteomics International (PILL) presented validation data at this week's American Diabetes Association annual meeting in San Diego that indicates its PromarkerD test could be helpful in identifying patients at risk of developing diabetic kidney disease.
In a prospective clinical study following 792 type 2 diabetes patients over four years, the company found that the test could identify patients who would develop kidney disease within that time period with a sensitivity of 86 percent and a specificity of 78 percent.
The study followed patients from the Fremantle Diabetes Study, a longitudinal, community-based study led by the University of Western Australia. Using mass spectrometry to measure six markers, PILL researchers developed four test models in an initial 345-patient training set. They then validated the models in an independent 447-patient cohort, which yielded the final three-protein assay.
PILL plans to launch an ELISA-based version of the test in the Dominican Republic this year through its partner Omic Global Solution, said Chuck Morrison, PILL's head of business development. PILL signed that deal, its first international licensing agreement for the PromarkerD test, in August 2016. According to a statement from the company, the deal is "worth in excess of $1.5 million."
The company is also pursuing commercialization of the test in other countries including China, the US, Australia, and parts of Europe, Morrison said. With regard to the US market, it is considering several different commercialization routes, including offering the assay as a laboratory-developed test through a CLIA lab; licensing it to a large in vitro diagnostic company that could take it through the US Food and Drug Administration process and then sell it as a kit; or partner with a pharmaceutical company working therapies for kidney disease to develop the test for use in clinical trials and then potentially as a companion diagnostic.
In any case, PILL will not bring the test to market itself but instead plans to license it to larger firms with the resources needed to commercialize a proteomic diagnostic, Morrison said.
"We won't have the infrastructure in place ourselves," he said, noting that the company was "still a small entity" of around 20 employees, most of them on the science side.
Founded in 2001, PILL went public last year, raising A$3.1 million (US$2.4 million) and listing on the ASX. The close of the IPO came after the company pushed back an IPO initially planned for 2015 and lowered its minimum raise from A$4 million to A$3 million. At the time it said it lowered the target raise due to an influx of funds from an agreement with Chinese biopharma firm New Summit Biopharma to commercialize the PromarkerD test in China.Â
Under that deal, New Summit provided A$1.1 million in funding to further develop and commercialize the test.
Morrison said this week that the IPO provided enough funding for the company to operate for the next several years, but that the company is open to additional funding.
In 2016, the company posted a loss of A$1.3 million on revenues of A$1.4 million and ended the year with A$582,256 in cash and cash equivalents. Of PILL's 2016 income, A$572,269 was from an Australian research and development tax incentive, while $816,845 consisted of revenues from its proteomics services business, which Morrison said was currently the company's primary source of revenue.
The company offers services including drug development assays and protein biomarker discovery, Morrison said. The company provides a variety of mass spec-based proteomic analyses including shotgun-style experiments, targeted multiple-reaction monitoring assays, isobaric labeling assays, and analyses of protein post-translational modifications.
PILL is also looking to expand on its work in diabetic patients, Morrison said, noting that the company is working with subjects from the Fremantle study to explore protein biomarkers for conditions including diabetic retinopathy and cardiovascular events linked to diabetes.
It also has ongoing internal biomarker development projects in diseases including endometriosis, chronic obstructive pulmonary disease, and mesothelioma.