PreMD Submits 510(k) Application to FDA for PREVU(x) LT
November 06 2006 - 10:04AM
PR Newswire (US)
- New PREVU(x) format aimed initially at the life insurance market
- Targeted to Predicting TC:HDL Ratio TORONTO, Nov. 6
/PRNewswire-FirstCall/ -- Predictive medicine company PreMD Inc.
(TSX: PMD; Amex: PME) today announced that it has submitted a
premarket notification or 510(k) to the U.S. Food and Drug
Administration (FDA) for clearance of PREVU(x) LT, the
lab-processed format of the PREVU(x) technology. PREVU(x)LT is the
second product in the PREVU(x) line of skin sterol tests and has
been developed for use within the insurance industry and diagnostic
laboratories. PreMD submitted its application to seek clearance to
market the test in the U.S. for use as a predictor of the ratio of
total cholesterol (TC) to high density lipoprotein (HDL), the
TC:HDLratio, in the insurance industry. Both total cholesterol and
HDL are measured from a sample of blood. PREVU(x) LT non-invasively
measures the amount of cholesterol that has accumulated in the skin
tissues, as opposed to blood, by using a specially designed
adhesive strip to painlessly collect skin cells from the palm of
the hand. The sample is then sent to a laboratory for processing.
No fasting or other patient preparation is required for the test.
PREVU(x) LT has been Conformite Europeene (CE)-marked in Europe and
has been cleared for sale in Canada. The FDA submission included
clinical data from the recently completed PREPARE (PREVU(x)
Predicts Atherosclerosis Risk and Events) study, conducted in the
insurance industry with the participation of selected U.S. life
insurers. The product was compared to traditional risk assessment
measures. "We expect clearance of this new test format to
significantly expand the market potential for PREVU(x), starting
with the life insurance industry," said Dr. Brent Norton, President
and Chief Executive Officer. "Through our management of the PREPARE
clinical trial we have already made significant inroads with
insurance providers, which puts us in a good position for
commercialization. We are excited about the prospects for this
product and realizing the full commercial potential of the entire
PREVU(x) product line." Typical response times for 510(k)
submissions are approximately 90 days if there are no questions or
other issues. About PreMD PreMD Inc. is a world leader in
predictive medicine, dedicated to developing rapid, non-invasive
tests for the early detection of life-threatening diseases. PreMD's
cardiovascular products are branded as PREVU(x) Skin Sterol Test.
The company's cancer tests include ColorectAlert(TM), LungAlert(TM)
and a breast cancer test. PreMD's head office is located in
Toronto, and its research and product development facility is at
McMaster University in Hamilton, Ontario. For further information,
please visit http://www.premdinc.com/. This press release contains
forward-looking statements. These statements involve known and
unknown risks and uncertainties, which could cause the Company's
actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the successful development or marketing of the
Company's products, the competitiveness of the Company's products
if successfully commercialized, the lack of operating profit and
availability of funds and resources to pursue R&D projects, the
successful and timely completion of clinical studies, product
liability, reliance on third-party manufacturers, the ability of
the Company to take advantage of business opportunities,
uncertainties related to the regulatory process, and general
changes in economic conditions. In addition, while the Company
routinely obtains patents for its products and technology, the
protection offered by the Company's patents and patent applications
may be challenged, invalidated or circumvented by our competitors
and there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. Investors
should consult the Company's quarterly and annual filings with the
Canadian and U.S. securities commissions for additional information
on risks and uncertainties relating to the forward-looking
statements. Investors are cautioned not to rely on these
forward-looking statements. PreMD is providing this information as
of the date of this press release and does not undertake any
obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or
otherwise. (x) Trademark DATASOURCE: PreMD Inc. CONTACT: Brent
Norton, President and CEO, Tel: (416) 222-3449 ext. 22, Email: ;
Ron Hosking, Chief Financial Officer, Tel: (416) 222-3449 ext. 24,
Email:
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