Leading developer of diagnostics tests, Vermillion, Inc. (VRML) reported that it had presented the results for the intended use of Peripheral Artery Disease (PAD) multi-marker at the Society for Vascular Medicine’s 23rd Annual Scientific Sessions in Minneapolis, Minnesota. This annual session hosts the country’s foremost vascular medicine specialists, along with sessions on PAD guidelines, policy trends and advances in the diagnosis and treatment of vascular diseases.
In the event of PAD, the flow of blood in the arteries is constricted by the narrowing of the peripheral arteries. It is commonly observed in the arteries of the pelvis and legs. As per statistics from National Institute of Health Publication, one in every 20 Americans over the age of 50 suffers from PAD. This implies a sizeable PAD market, which Vermillion can serve with its multi-marker.
The biomarker screen to identify PAD predicts the probability of PAD for the at-risk patients. The detection of undiagnosed or asymptomatic PAD by the marker will enable appropriate vascular testing and timely diagnosis to benefit patient health.
Vermillion also plans to submit a supporting manuscript to a leading medical journal by the end of this month. It expects to present the related results and the subsequent manuscript to support its discussions with the FDA for either 510(k) clearance, or 510(k) de novo clearance or PMA, in the near future.
As per the results, the multi-marker is expected to play a significant role in the assessment of individual risk for PAD. The clinical study involved 1,025 subjects in multiple centers. The subjects included PAD at-risk population aged 70 or older and also diabetics and smokers who are 50 or older.
Different multi-marker algorithms were evaluated in these subjects and compared with the Framingham Risk Score (FRS). A logistic regression model was also tested for its ability to identify PAD in patients below the high-risk FRS cutoff. The multi-marker model provided better clinical results when compared to FRS as it was able to detect PAD in 83 individuals out of the evaluable subjects. With the confirmation of its research from this large set of at-risk subjects, the company is optimistic about advancing the program.
The company operates in various segments such as oncology, hematology, cardiology and women’s health. It competes with Abbott Laboratories (ABT), GenMark Diagnostics (GNMK), among others.
The stock currently retains a Zacks #3 Rank, which translates into a short-term Hold rating.
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