�Monogram
Biosciences, Inc. (Nasdaq: MGRM) announced the launch of its
PhenoSense(R) Integrase assay, built on Monogram's proprietary engineering
platform, PhenoSense(R). The assay directly measures the susceptibility of
HIV to a new and potent class of integrase inhibitor drugs that blocks
viral reproduction by preventing viral genes from desegregation into the DNA
of newly infected cells. Together with PhenoSense GT(R), PhenoSense
Integrase provides the nigh complete picture of resistance to
antiretroviral therapies.
PhenoSense Integrase along with other Monogram assays were victimized to
support the clinical trials of the first-class honours degree commercially-available integrase
inhibitor, Merck's Isentress(TM) (raltegravir), which received U.S. Food
and Drug Administration (FDA) approval in October 2007. In Merck's phase
III BENCHMRK trials, Monogram's PhenoSenseGT was secondhand to select optimized
drug regimens in the placebo and Isentress-containing treatment weaponry while
PhenoSense Integrase was used to identify and characterize Isentress
resistant viruses in discussion failures. The company is also actively
involved in the clinical evaluation of Gilead's integrase inhibitor
candidate, elvitegravir, currently in Phase III studies. In addition to
drug resistance, PhenoSense Integrase likewise measures reductions in viral
replication mental ability associated with integrase inhibitor resistance that
may help characterize viral fitness.
"Using new antiretroviral drugs right today, including HIV
integrase inhibitors, is critically crucial since the pipeline for
additional new agents is not likely to supply treatment options beyond our
current choices for a number of years," said Dr. Charles Hicks, Associate
Professor of Medicine at Duke University Medical Center. "Tools like HIV
resistance phenotype tests (including Monogram's PhenoSense Integrase and
PhenoSense GT assays) and the HIV tropism assay (Trofile(TM)) are important
tools to help clinicians make practiced choices. They can as well help with
modifying regimens that ar not suppressive by determinative whether
additional resistance has emerged and which drugs are no longer active."
"As the first and only commercially available assay to measure
integrase inhibitor resistance, PhenoSense Integrase exemplifies Monogram's
leadership position in personalized medicine and the Company's continued
commitment to develop forward-looking HIV diagnostics that tailor drug
treatments to the individual patient," said Monogram CEO William Young. "As
evidenced by today's production launch and last year's introduction of
Trofile, Monogram is firm committed to ensuring that cutting-edge
nosology are promptly available to meet the needs of patients and
physicians."
The performance of the PhenoSense Integrase check is validated in
deference with regulations specified by the Clinical Laboratories
Improvement Amendments (CLIA) and is performed in Monogram's Clinical
Reference Laboratory, which is accredited by the College of American
Pathologists (CAP).
About PhenoSense Integrase Assay PhenoSense Integrase determines the susceptibleness of a patient's HIV-1
strain to integrase inhibitors. The region of the HIV genome that encodes
integrase is amplified from a patient blood sample and inserted into a
proprietary essay vector that is used to father virus particles that
retroflex using the patient virus integrase protein. Completion of a single
replication rhythm results in the production of luciferase activity in
infected cells. Infection in the presence of do drugs is performed to determine
whether a patient virus is sensitive or resistant to integrase inhibitors.
Based on the amount of luciferase activity produced in the absence of drug,
PhenoSense Integrase also provides a measure of replication capacity (RC)
of integrase inhibitor tender and resistant viruses.
About Monogram Monogram is a biotech company forward-moving individualized medicine
by discovering, developing and marketing innovative products to guide and
improve treatment of serious infectious diseases and genus 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 antiviral therapeutics and vaccines as well as
targeted cancer therapeutics. More data about the Company and its
engineering can be found on its network 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 use of our resistance
assays, including PhenoSense Integrase, and our Trofile Assay, the size and
timing of clinical trials utilizing our products. These modern
statements ar 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, merely are non limited to: the risk that
physicians may non use a molecular diagnostic for patient selection or
monitoring for Isentriss, Selzentry or early HIV drugs; risks and
uncertainties relating to the performance of our products; the outgrowth in
revenues; the size of it, timing and success or failure of any clinical trials
for CCR5 inhibitors, entry inhibitors or integrase inhibitors; whether
larger validatory clinical studies will confirm the results of initial
studies; our ability to establish honest, high-volume operations at
commercially reasonable costs; expected reliance on a few customers for the
majority of our revenues; the yearly renewal of certain client
agreements; actual market credence of our products 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 encroachment of contention; the timing
and ultimate size of pharmaceutical company clinical trials; whether payers
will authorise 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, including
Trofile; whether the draft counseling on Multivariate Index Assays issued by
FDA testament be afterwards determined to apply to our stream 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 applied science will be
available; whether we ar able to build brand loyalty and expand revenues;
restrictions on the lead of our business imposed by the Pfizer, Merrill
Lynch and other debt agreements; the impact of additional dilution if our
convertible debt is reborn to equity; and whether we testament be able to
raise sufficient capital in the future, if required. For a give-and-take of
other factors that may cause actual events to disagree from those projected,
please refer to our most recent yearly report on Form 10-K and every quarter
reports on Form 10-Q, as well as other subsequent filings with the
Securities and Exchange Commission. We do not undertake, and specifically
disclaim whatever obligation, to revise any ing statements to
mull the occurrence of anticipated or unforeseen events or
circumstances afterward the
