NEW YORK – Having recently secured a US licensing deal with Sonic Healthcare USA and Medicare coverage for its PromarkerD test for diabetic kidney disease, Australian diagnostics firm Proteomics International Laboratories (PILL) expects to broadly launch the test starting in early 2024.
The launch will mark the first major commercial push for the proteomic test, which is intended to assess the likelihood that an individual with diabetes will go on to develop diabetic kidney disease.
PromarkerD measures the levels of three plasma proteins — apoA4, CD5L, and IGFBP3 — and combines those measurements with an individual's age, HDL-cholesterol level, and eGFR to predict a type 2 diabetes patient's risk of developing diabetic kidney disease within four years.
PILL has been developing the test for more than a decade and has entered agreements for sales of the assay in countries including Israel and Italy, but the recent Sonic licensing deal and Medicare coverage decision mark perhaps the most significant commercial developments to date for the firm.
Richard Lipscombe, managing director of PILL, noted that the company has been active in "test markets" including Puerto Rico and Central America but said the forthcoming US release will be the test's "first launch in a major international market."
PILL inked the Sonic licensing deal in May of this year. Under the terms of the five-year agreement, Sonic is responsible for sales and marketing of the test and will pay PILL a royalty per test. Lipscombe declined to specify the royalty amount, but said that the company has previously indicated that it considers 5 to 15 percent to be the industry standard and that the Sonic deal is in line with this.
Lipscombe noted that while the licensing agreement was signed in May, Sonic has been waiting for a reimbursement figure from the Centers for Medicare and Medicaid Services (CMS) before rolling the test out commercially. That came this month, with CMS assigning the test a payment rate of $390.75, effective Jan. 1, 2024.
"The pricing becoming effective at the beginning of next year will obviously greatly aid the whole reimbursement process, and so the expectation is that [sales] will go live early in 2024," Lipscombe said.
He estimated that roughly 40 percent of the test's potential market, which PILL considers to be the roughly 32 million people in the US with type 2 diabetes, is covered by Medicare. He said that work is ongoing to secure private payor coverage but that this will primarily be Sonic's responsibility, with PILL acting in a supporting role. Sonic will offer PromarkerD as a laboratory-developed test, and Lipscombe said there are not currently plans to take it through the US Food and Drug Administration.
PILL has conducted several studies evaluating the test's performance. In 2020, the company presented results from an analysis of 3,000 subjects in which its researchers found that patients identified as high risk by the test were 13.5 times more likely than patients identified as low risk to develop chronic kidney disease within the next four years. Patients identified as being at moderate risk were 5.3 times more likely to develop CKD than low-risk patients.
That followed a four-year, 792-patient study published in 2017 that found that the test identified patients who would go on to develop kidney damage in the next four years with a sensitivity of 86 percent and specificity of 78 percent.
More recently, PILL has begun exploring whether the test can monitor patient response to type 2 diabetes drugs like SGLT2 inhibitors. In May, company researchers published a study in the Journal of Clinical Medicine in which they found that patients treated with Janssen's SGLT2 inhibitor Invokana (canagliflozin) saw a decrease in their PromarkerD scores (indicating a decreased risk of diabetic kidney disease) over the course of three years while patients on placebo saw an increase in their PromarkerD scores.
Lipscombe said the company is currently in discussions with other pharma companies about doing similar studies, though he did not name any specific firms.
PILL is also looking to commercialize the test in geographies beyond the US, Lipscombe said, noting that it will look to tackle the UK and continental Europe next. The test has CE mark registration. This year, PILL extended by five years an ongoing agreement with diagnostics firm Apacor initially signed in 2021 to sell PromarkerD in the UK market. Lipscombe said the company is also involved in discussions with potential lab partners in several other European countries.
In addition to PromarkerD, PILL is developing a proteomic test for the early detection of endometriosis, which Lipscombe said is the next major priority in its pipeline. He said the company has done preliminary studies in roughly 1,000 patients, developing a classifier that distinguishes between individuals with endometriosis and health controls. He said the company is now establishing a number of clinical sites to set up an independent validation study for the test and that it hopes to present results from the study in the middle of next year.
PILL currently has around 30 employees. The company is listed on the Australian Securities Exchange and in its fiscal year 2023 posted A$3.3 million ($2.2 million) in revenue and a loss of A$6.2 million. More than half its revenues came from an R&D tax incentive, while research grants contributed A$593,328 and its pharma services business contributed A$730,340.