LONDON - Shield Diagnostics, of Dundee, Scotland, received 510(k) market approval from the FDA for its test for the novel marker activated Factor XII, which it claims is a more potent indicator than cholesterol levels of cardiovascular disease.
“It is our intention to devote a significant amount of time and resource to the marketing and commercialization of this test, not only in the U.S. market, but throughout the world,“ said David Evans, managing director of Shield.
While the clinical data backing the approval of the test, called Afecta, may show it is a better indicator of disease, the testing of cholesterol levels is an entrenched and easily understood marker for risk of cardiovascular trouble.
“We cannot expect Afecta immediately to replace cholesterol testing,“ Evans said. “Therefore, Shield intends to apply Afecta firstly to those patients who are at the greatest risk of suffering heart attack or stroke, and only once this has been accepted to market Afecta as a general population screen.“
Shield has yet to find a marketing partner in the U.S., though earlier this year the company signed an agreement with Abbott Laboratories, of Abbott Park, Ill., which could pave the way to commercialization. The deal allows Shield to develop, manufacture and distribute the Afecta assay on Abbott's IMx instrumentation. Evans said Shield intends to enter into further alliances with other diagnostics companies, giving access to different instrument bases.
The Afecta test uses patented monoclonal antibody technology to differentiate between activated and non-activated Factor XII. Activation of this blood factor is at the start of the blood clotting cascade, and several studies have found that activated Factor XII levels are significantly elevated in patients with conditions such as atherosclerosis and high blood lipid levels.
Shield's data indicate that an increase in the circulating levels of activated Factor XII is an early indicator that the equilibrium in the system is being moved towards over-activation of the clotting process. The company claims this is a more consistent indicator of cardiovascular risk than measuring cholesterol, because there can be large variations in individuals' cholesterol levels over a short period of time.
Shield's shares rose by £0.375 to £5.13 when the approval was announced Sept. 1. *