Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a
global leader in molecular diagnostics and precision medicine,
today announced that a new analysis of the GUIDED1 clinical trial
was published online in The Journal of Clinical Psychiatry. The key
finding is that the GeneSight® Psychotropic test improved clinical
outcomes – remission, response and symptoms – in patients taking
medications with gene-drug interactions. Improvement in all three
endpoints was statistically significant.
“Treatment decisions for people with major depressive disorder
are challenging, particularly for patients who have already not
benefitted from one or more medications,” said Michael E. Thase
M.D., lead author and professor of psychiatry, Perelman School of
Medicine, University of Pennsylvania. “In some cases, nonresponse
or intolerance to a standard antidepressant can result from a
gene-drug interaction. When that’s the case, you want to select a
different medication that doesn’t have that interaction.”
Patients enrolled in the GUIDED clinical trial were diagnosed
with major depressive disorder (MDD) and had failed at least one
psychotropic medication. Patients were randomized to treatment as
usual (TAU) or the guided-care arm in which clinicians had access
to the GeneSight test report to inform their medication decisions.
The analysis published in the Journal of Clinical Psychiatry today
evaluated a total of 787 people from the GUIDED clinical trial who
were taking medications with gene-drug interactions at baseline as
identified by the GeneSight test.
The results from the analysis showed that people in the
GeneSight arm (n=357) achieved statistically significant
improvements in all clinical outcomes compared to TAU (n=430) at
week 8 (Figure 1).
To view Figure 1: GeneSight Provided Significant
Improvements in All Patient Outcomes, please visit the
following
link: https://www.globenewswire.com/NewsRoom/AttachmentNg/c936641a-599d-4e45-bcfd-3efa8ea48cad
Importantly, the improvements in all clinical outcomes were
durable and continued throughout the six-month follow up period.
Remission increased 82 percent, response rates increased 64 percent
and symptom improvement increased 56 percent from week 8 to week 24
(Figure 2).
To view Figure 2. GeneSight Clinical Benefits Were
Durable and Improved Over Time, please visit the following
link: https://www.globenewswire.com/NewsRoom/AttachmentNg/9950226f-41f2-405d-958d-ad95f8152060
“Patient outcomes in the GeneSight-guided arm were superior to
treatment-as-usual. Additionally, patients continued to get better
over time and the rate of remission, which is the goal of
treatment, nearly doubled from week 8 to week 24,” said Dr. Thase.
“Too often patients with difficult-to-treat depression relapse, and
this data shows that the patient benefits in the GeneSight-guided
arm were durable.”
The new analysis also assessed how the GeneSight test impacted
outcomes for patients who were taking medications with gene-drug
interactions at baseline and who switched medications, which was
defined as dropping at least one medication and adding at least one
different medication. Among people who switched, all clinical
outcomes were statistically significantly better for those in the
GeneSight arm (n=235) compared to TAU (n=225) at week 8,
underscoring the value of using combinatorial pharmacogenomic
information to help inform treatment decisions (Figure
3).
To view Figure 3.
GeneSight Improved Outcomes for Patients
Switching Medications, please visit the following
link: https://www.globenewswire.com/NewsRoom/AttachmentNg/429f2e06-f03d-4a20-bc3e-17b330940cf5
“The GeneSight test identified patients taking medications with
gene-drug interactions, and physicians were able to use this
information to switch patients to medications with fewer gene-drug
interactions and improve their outcomes,” said Michael R.
Jablonski, Ph.D., vice president of Medical Affairs, Myriad
Neuroscience. “This is an important first step in the journey
towards making precision medicine a reality for people suffering
from depression.”
About GeneSight®
PsychotropicGeneSight Psychotropic is a
pharmacogenomic test that analyzes clinically important variations
in DNA. The results of the test can inform doctors about genes that
may impact how their patients metabolize or respond to depression
medications.
About Myriad GeneticsMyriad Genetics Inc., is a
leading precision medicine company dedicated to being a trusted
advisor transforming patient lives worldwide with pioneering
molecular diagnostics. Myriad discovers and commercializes
molecular diagnostic tests that: determine the risk of developing
disease, accurately diagnose disease, assess the risk of disease
progression, and guide treatment decisions across six major medical
specialties where molecular diagnostics can significantly improve
patient care and lower healthcare costs. Myriad is focused on five
critical success factors: building upon a solid hereditary cancer
foundation, growing new product volume, expanding reimbursement
coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate 2020. For
more information on how Myriad is making a difference, please visit
the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore, Prolaris,
ForeSight and Prequel are trademarks or registered trademarks of
Myriad Genetics, Inc. or its wholly owned subsidiaries in the
United States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements relating to combinatorial pharmacogenomic testing
augmenting physician decision-making and helping people get well;
making precision medicine a reality for people suffering from
depression; and the Company's strategic directives under the
caption "About Myriad Genetics." These "forward-looking statements"
are based on management's current expectations of future events and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by forward-looking statements. These risks and
uncertainties include, but are not limited to: the risk that sales
and profit margins of our molecular diagnostic tests and
pharmaceutical and clinical services may decline; risks related to
our ability to transition from our existing product portfolio to
our new tests, including unexpected costs and delays; risks related
to decisions or changes in governmental or private insurers’
reimbursement levels for our tests or our ability to obtain
reimbursement for our new tests at comparable levels to our
existing tests; risks related to increased competition and the
development of new competing tests and services; the risk that we
may be unable to develop or achieve commercial success for
additional molecular diagnostic tests and pharmaceutical and
clinical services in a timely manner, or at all; the risk that we
may not successfully develop new markets for our molecular
diagnostic tests and pharmaceutical and clinical services,
including our ability to successfully generate revenue outside the
United States; the risk that licenses to the technology underlying
our molecular diagnostic tests and pharmaceutical and clinical
services and any future tests and services are terminated or cannot
be maintained on satisfactory terms; risks related to delays or
other problems with operating our laboratory testing facilities and
our healthcare clinic; risks related to public concern over genetic
testing in general or our tests in particular; risks related to
regulatory requirements or enforcement in the United States and
foreign countries and changes in the structure of the healthcare
system or healthcare payment systems; risks related to our ability
to obtain new corporate collaborations or licenses and acquire new
technologies or businesses on satisfactory terms, if at all; risks
related to our ability to successfully integrate and derive
benefits from any technologies or businesses that we license or
acquire; risks related to our projections about our business,
results of operations and financial condition; risks related to the
potential market opportunity for our products and services; the
risk that we or our licensors may be unable to protect or that
third parties will infringe the proprietary technologies underlying
our tests; the risk of patent-infringement claims or challenges to
the validity of our patents or other intellectual property; risks
related to changes in intellectual property laws covering our
molecular diagnostic tests and pharmaceutical and clinical services
and patents or enforcement in the United States and foreign
countries, such as the Supreme Court decision in the lawsuit
brought against us by the Association for Molecular Pathology et
al; risks of new, changing and competitive technologies and
regulations in the United States and internationally; the risk that
we may be unable to comply with financial operating covenants under
our credit or lending agreements; the risk that we will be unable
to pay, when due, amounts due under our credit or lending
agreements; and other factors discussed under the heading "Risk
Factors" contained in Item 1A of our most recent Annual Report on
Form 10-K for the fiscal year ended June 30, 2019, which has been
filed with the Securities and Exchange Commission, as well as any
updates to those risk factors filed from time to time in our
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All
information in this press release is as of the date of the release,
and Myriad undertakes no duty to update this information unless
required by law.
Media Contact:Ron Rogers(801)
584-3065 rrogers@myriad.com |
Investor Contact:Scott Gleason(801)
584-1143sgleason@myriad.com |
1 Greden JF, Parikh SV, Rothschild AJ, et al. Impact of
pharmacogenomics on clinical outcomes in major depressive disorder
in the GUIDED trial: A large, patient- and rater-blinded,
randomized, controlled study. J Psychiatr Res. 2019; 111:59-67.
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