Monogram Announces Commercial Availability of the HERmark(TM) Breast Cancer Assay
July 08 2008 - 5:00AM
PR Newswire (US)
Accurate and Quantitative Measurement of Breast Cancer Patient's
HER2 Status Now Available to Physicians SOUTH SAN FRANCISCO,
Calif., July 8 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc.
(NASDAQ:MGRM) today announced that, effective July 15, the
HERmark(TM) Breast Cancer Assay will be available to physicians
throughout the U.S. for assessment of HER2 status in patients with
breast cancer. HERmark provides a precise and quantitative
measurement of HER2 total protein and HER2 homodimer levels and
will be offered as a CLIA-validated assay through Monogram's
CAP-certified clinical laboratory. Physicians currently use
semi-quantitative measures to determine HER2 status as an indicator
of HER2 protein over-expression or HER2 gene amplification to
determine whether or not to prescribe Herceptin(R). Inaccurate
measurements of HER2 status may lead to inappropriate therapy
selection. Guidance recently issued jointly by ASCO and CAP (the
College of American Pathologists) indicated that approximately 20%
of HER2 determinations by current testing technologies may be
inaccurate. "HER2 targeted therapies have been proven to be
critical in the treatment of women with HER2-positive breast
cancer," said Peter A. Kaufman, MD, Associate Professor of Medicine
at the Norris Cotton Cancer Center, Dartmouth- Hitchcock Medical
Center. "Breast cancer researchers and oncologists have come to
agree that current testing methods for HER2 are not adequate.
HERmark's direct quantitative measurements of HER2 total protein
and HER2 homodimer levels provide much needed insight as to the
real HER2 status of a patient's breast cancer. This technology may
allow us to more accurately determine which patients will, and
which won't, benefit from the use of Herceptin as part of their
overall therapy." "We have correlated the HERmark assay with IHC,
FISH and CISH results obtained in central laboratories in more than
one thousand patients, and we see a high degree of concordance
between the best central lab tests and HERmark," said Michael
Bates, M.D., Vice President of Clinical Research at Monogram.
"Importantly, HERmark identifies patients with high HER2 levels but
who are HER2-negative by other assays, as well as some patients
with low HER2 levels but who are judged positive by conventional
assays. Comparisons with local lab results by IHC or FISH suggest
significantly larger numbers of discordant results. We believe the
HERmark Assay measures HER2 total protein and homodimer levels very
accurately and will help physicians to make treatment decisions
with high confidence." HERmark will be commercialized by Monogram
through its direct sales and marketing organization. "Our existing
commercial organization is being supplemented with oncology-focused
sales and medical affairs personnel," said William Welch, Monogram
chief commercial officer. "With HERmark's availability for patient
testing, our oncology team will immediately begin introducing
HERmark to medical oncologists in both key centers of excellence
and large community hospitals throughout the U.S." "Today is the
beginning of a new era for Monogram with the introduction of our
HERmark Breast Cancer Assay for patient testing, the first product
based on our VeraTag(TM) technology platform," said William Young,
Monogram chief executive officer. "With HERmark, physicians now
have a way to get an accurate and reliable quantitative measurement
of their patients' HER2 status to help guide personalized therapy.
We are looking forward to further developing this technology in
order to provide the oncology community other VeraTag based assays
that will provide more comprehensive and accurate information on a
individual patient's tumor profile." About the HERmark Breast
Cancer Assay HERmark is a proprietary diagnostic that accurately
quantifies HER2 total protein levels and HER2 homodimerization in
patients with breast cancer. HERmark is a CLIA-validated assay that
is performed exclusively in Monogram's CAP-certified clinical
reference laboratory in South San Francisco. Robust, accurate,
sensitive and reproducible measurements of HER2 status are reported
to physicians with a turnaround time of 7 days. With the accurate
measurements provided by HERmark, it is expected that as many as
15-20% of patients determined by conventional technologies to be
HER2- negative would be reclassified by HERmark. Key advantages of
the HERmark Breast Cancer Assay include: -- HERmark is highly
sensitive and can detect HER2 at levels from 2,500 to over 1
million receptors per cell -- 7 to 10 times more sensitive than
IHC. -- HERmark provides a better measure of HER2 status by
measuring the drug target -- the HER2 protein and HER2 homodimers
-- rather than the HER2 gene. -- The HERmark report is simple to
interpret and provides a specific quantitative measure of HER2
expression, a HER2 status of "positive", "negative" or "equivocal"
and indicates, relative to conventional measurements, how positive
or how negative the patient is. -- Clinical studies demonstrate
that HERmark is an accurate method for stratifying patients with
metastatic breast cancer who are more likely to respond to
Herceptin-containing therapy. Assay measurements: Physicians
ordering HERmark receive a report indicating a specific
quantitative measurement of the levels of HER2 total protein and
HER2 homodimer, together with a comparison of where the patient's
level of HER2 total protein falls within ranges of HERmark
measurements that have been previously correlated in over 1,000
patients with HER2-positive and HER2-negative status by central
laboratory FISH and IHC assessments. The report indicates HERmark
status of "positive", "negative" and "equivocal". The boundaries
for the equivocal zone represent an upper level above which 95% are
positive and a lower level below which 95% are negative patients.
Additional information on the HERmark Breast Cancer Assay can be
found at http://www.hermarkassay.com/. Clinical data: Preliminary
data from three cohorts of Herceptin-treated patients with
metastatic breast cancer who were identified as "HER2 positive" by
conventional assays suggest that HERmark can identify patients who
are likely to respond to Herceptin with greater precision than
currently available tests. Additional studies of HERmark for breast
cancer in both the metastatic and adjuvant settings are in
progress. About VeraTag VeraTag is a proximity-based assay
technology platform that accurately quantifies proteins and
functional protein complexes. This platform provides a researcher
or clinician a more thorough understanding of protein-protein
interactions or signaling pathway activity allowing for disease
characterization at the molecular level. Assays based on the
VeraTag technology platform are designed to run on standard
formalin-fixed paraffin embedded (FFPE) patient samples. About
Monogram Monogram is advancing individualized medicine by
discovering, developing and marketing innovative products to guide
and improve treatment of serious infectious diseases and cancer.
The Company's products are designed to help doctors optimize
treatment regimens for their patients that lead to better outcomes
and reduced costs. The Company's technology is also being used by
numerous biopharmaceutical companies to develop new and improved
anti-viral therapeutics and vaccines as well as targeted cancer
therapeutics. More information about the Company and its technology
can be found on its web site at http://www.monogrambio.com/.
Forward Looking Statements Certain statements in this press release
are forward-looking. These forward-looking statements include
references to the ability of the HERmark assay to predict response
to Herceptin or to significantly improve the information available
to physicians, results of studies intended to demonstrate clinical
utility of HERmark, and successful commercialization of the HERmark
assay or other VeraTag assays. These forward-looking statements are
subject to risks and uncertainties and other factors, which may
cause actual results to differ materially from the anticipated
results or other expectations expressed in such forward-looking
statements. These risks and uncertainties include, but are not
limited to: risks and uncertainties relating to the performance of
our products, including HERmark; the risk that our VeraTag assays,
including HERmark may not predict response to Herceptin or other
therapeutic agents; the risk that we may not be able to obtain
additional cohorts of patient samples for additional HERmark or
VeraTag studies; our ability to successfully conduct clinical
studies and the results obtained from those studies; whether larger
confirmatory clinical studies will confirm the results of initial
studies; our ability to establish reliable, high-volume operations
at commercially reasonable costs; actual market acceptance of our
products for patient use and adoption of our technological approach
and products by pharmaceutical and biotechnology companies; our
estimate of the size of our markets; our estimates of the levels of
demand for our products; the impact of competition; whether payers
will authorize reimbursement for our products and services and the
amount of such reimbursement that may be allowed; whether the FDA
or any other agency will decide to further regulate our products or
services; whether the draft guidance on Multivariate Index Assays
issued by FDA will be subsequently determined to apply to our
current or planned products; whether we will encounter problems or
delays in automating our processes; the ultimate validity and
enforceability of our patent applications and patents; the possible
infringement of the intellectual property of others; whether
licenses to third party technology will be available; whether we
are able to build brand loyalty and expand revenues; restrictions
on the conduct of our business imposed by the Pfizer, Merrill Lynch
and other debt agreements; the impact of additional dilution if our
convertible debt is converted to equity; and whether we will be
able to raise sufficient capital in the future, if required. For a
discussion of other factors that may cause actual events to differ
from those projected, please refer to our most recent annual report
on Form 10-K and quarterly reports on Form 10-Q, as well as other
subsequent filings with the Securities and Exchange Commission. We
do not undertake, and specifically disclaim any obligation, to
revise any forward-looking statements to reflect the occurrence of
anticipated or unanticipated events or circumstances after the date
of such statements. VeraTag and HERmark are trademarks of Monogram
Biosciences, Inc. Herceptin is a registered trademark of Genentech,
Inc. Contacts: Alfred G. Merriweather Jeremiah Hall Chief Financial
Officer Feinstein Kean Healthcare Tel: 650 624-4576 Tel: 415
677-2700 amerriweather@ jeremiah.hall@ monogrambio.com fkhealth.com
DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred G.
Merriweather, Chief Financial Officer of Monogram Biosciences,
Inc., +1-650-624-4576, , or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, , for Monogram Biosciences, Inc. Web
site: http://www.monogrambio.com/ http://www.hermarkassay.com/
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