QuantRx Biomedical Submitted a 510(k) Application to FDA for Thyroid Point-of-Care Testing System Following Successful Comple...
June 09 2010 - 8:41AM
Business Wire
QuantRx® Biomedical Corporation (OTCBB: QTXB), a broad-based
diagnostic company focused on the development and commercialization
of innovative diagnostic products, today announced that it has
completed clinical testing of the Q-Reader™ thyroid testing system.
QuantRx Biomedical Corporation is pleased to be at this regulatory
stage, which follows the completion of studies showing that the
innovative Q-Reader thyroid testing system is capable of providing
healthcare practitioners with laboratory level quantitative results
within minutes, rather than waiting for results to be returned from
a commercial laboratory.
“We are very excited about meeting this critical milestone,”
stated Walter Witoshkin, QuantRx Chief Executive Officer. “With the
successful completion of our studies we believe we have made a
significant step forward for the first of many planned diagnostic
tests which are intended to provide rapid, low cost, quantitative
results. The ability to introduce our proprietary technology, which
will allow the healthcare professional to run in-clinic assays that
had only been available from a commercial laboratory before, will
be the basis of our market growth in both human and veterinary
diagnostics.”
The QN Diagnostics (QND) Q-Reader is a stand-alone instrument
with a liquid crystal display (LCD) touch screen located on the top
of the unit, and an integrated software analysis capability. Using
QND’s proprietary analysis software, the unit uses stored
calibration data provided with each QND Assay Kit and an analyte
concentration based upon the analyte-specific calibration curve to
display a quantifiable reading to the healthcare practitioner on
the LCD screen.
Proprietary QND Assays are housed within a plastic cassette,
which contains a QND-lateral flow Assay Strip. The test system is
intended for use at the point of care and to eliminate the need for
samples to be taken from the patient and shipped with related
documentation to an external laboratory, saving the time needed to
return the test results to the health care practitioner.
According to Frost & Sullivan Senior Consultant, “The global
in vitro diagnostics market has shown a consistent growth of 6.72
percent annually, a trend that is expected to continue until 2012.
Point-of-Care (POC), the largest segment, is estimated to grow into
an $18 billion market by 2012.”
At present, large commercial laboratories dominate this market,
but that will change as more innovative technologies enter the
arena. While the standard infrastructure clearly defines the
limitations between the healthcare practitioner and the laboratory
personnel, rapid POC technology, such as the Q-Reader system, will
soon blur these lines. POC rapid testing offering the potential for
process simplification as well as the other factors, are poised to
penetrate the diagnostics market aimed at the full spectrum of
opportunities.
About QuantRx Biomedical
(www.quantrx.com)
QuantRx Biomedical Corporation (OTCBB: QTXB) is focused on the
development and commercialization of innovative products for
advanced diagnosis of serious disease and health conditions. With
synergistic expertise in the discovery of diagnostic platforms
leveraging a vast portfolio of intellectual property, QuantRx’s
mission is to introduce products for use by medical professionals,
institutions, and consumers that deliver more accurate, reliable,
and faster diagnoses which result in improved patient care and a
reduction in overall healthcare costs.
The QuantRx strategy targets significant market opportunities
estimated to be in excess of $5 billion worldwide. The Company's
technology portfolio, with more than three dozen patents, patents
pending and licensed patents, includes: (1) RapidSense®
point-of-care testing products based on QuantRx core intellectual
property related to lateral flow techniques for the consumer and
healthcare professional markets (QN Diagnostics); (2) PAD
technology for over-the-counter applications, and the diagnosis and
treatment of women's health concerns and other medical needs, and
(3) significant investments in: (a) genome-based diagnostic chips
for the laboratory and healthcare professional markets; and (b)
molecular imaging agents for positron emission tomography (PET) and
fluorescence imaging, with initial application in cardiovascular
disease, addressing significant unmet medical needs by providing
clinicians with important tools for early discovery and
assessment.
This release may contain forward-looking statements within the
meaning of the federal securities laws. Such forward-looking
statements reflect, among other things, management's current
expectations, management's current plans and strategies, and
anticipated financial results, all of which are subject to known
and unknown risks, uncertainties and factors that may cause our
actual results to differ materially from those expressed or implied
by these forward-looking statements. Many of these risks are beyond
our ability to control or predict including; general economic
conditions, the Company’s need for additional funds, the early
state of the products the Company is developing, uncertainties
relating to clinical trials and regulatory reviews, competition and
dependence on collaborative partners, the Company's ability to
avoid infringement of the patent rights of others, and the
Company's ability to obtain adequate patent protection and to
enforce these rights. Because of these risks, uncertainties and
assumptions, you should not place undue reliance on these
forward-looking statements. Furthermore, forward-looking statements
speak only as of the date they are made. QuantRx does not undertake
any obligation to update or review any such forward-looking
information, whether as a result of new information, future events
or otherwise.
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