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
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
http://www.hermarkassay.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@monogrambio.com, or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com, for
Monogram Biosciences, Inc.
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