Vermillion announced this week it has been granted a US patent allowing it to use B2-microglobulin as a biomarker for its peripheral artery disease diagnostic Vasclir and that it has begun an intended-use population study for the test.
The patent, number 7,867,719, covers "biomarker combinations that include B2-microglobulin for the diagnosis and management of peripheral artery disease and to the measurement of the biomarkers by a variety of methods, including mass spectrometry and immunoassay," the company said in a statement.
Also in the statement, CEO Gail Page said that Vermillion continues "to progress in our PAD program, including the initiation of our intended-use study."
The granting of the patent follows on the notice of allowance for it that Vermillion received in September (PM 9/17/2010).
Vasclir is the second test Quest Diagnostics accepted from the company as part of the partners' three-test strategic alliance agreement. The first was the ovarian cancer assay OVA1.
During the company's second-quarter earnings call in August, chief science officer Eric Fung said developing Vasclir is one of Vermillion's primary R&D focuses, and noted the firm planned to begin an intended-use population study for the test by the end of 2010 (PM 08/13/2010).
According to Fung, PAD currently affects some 12 million Americans, a number that is expected to rise as the incidence of diabetes increases.
During the August earnings call, Page said that a commercial launch of Vasclir is likely still several years away.