NEW YORK – Australian diagnostics company Proteomics International said Friday that it has registered its US reference lab as a certified clinical laboratory under the Clinical Laboratory Improvement Amendment (CLIA).
The company will use the lab to offer its PromarkerD proteomic blood test for identifying individuals at risk of diabetes-related chronic kidney disease in US states that recognize CLIA certification. It also plans in the future to offer its PromarkerEso test for esophageal cancer and its PromarkerEndo test for endometriosis in the US.
Located in Irvine, California, the Proteomics International USA laboratory has also received a California state license, allowing the firm to offer its tests in that state.
Proteomics International said it plans to launch PromarkerD in the US in the second quarter of this year. It will launch the test initially as a direct-to-consumer test while seeking a licensing deal with major diagnostics companies.
Proteomics International had inked a US licensing deal for the test with Sonic Healthcare USA but the parties terminated the agreement in September. According to Proteomics International, the termination was due to a failure to meet certain milestones and performance indicators required under the agreement for commercialization of the test to occur.
"We see enormous market potential immediately for PromarkerD, and subsequently PromarkerEso and PromarkerEndo, to improve patient lives and save the US healthcare system millions of dollars," Proteomics International Managing Director Richard Lipscombe said in a statement.