Leading developer of diagnostics tests,
) 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 23
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
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
), among others.
The stock currently retains a Zacks #3 Rank, which translates
into a short-term Hold rating.
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