Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in
personalized medicine, today announced the publication of the
landmark GeneSight GUIDED study in the Journal of Psychiatric
Research. The study is the first-ever prospective, large-scale,
blinded, randomized controlled trial evaluating combinatorial
pharmacogenomics testing in 1,167 patients with treatment-resistant
major depressive disorder who had failed at least one psychotropic
medication.
“The publication of the GUIDED study represents a major
milestone for Myriad and a significant advance for pharmacogenomic
testing,” said Mark C. Capone, president and CEO, Myriad
Genetics. “The United States has a mental health care crisis
and GeneSight is a clinically proven solution to improve outcomes
for patients with depression.”The study showed that at week 8,
individuals in the GeneSight cohort had a 50 percent higher rate of
remission (p=0.007), a 30 percent higher rate of response (p=0.01),
and 11 percent greater improvement in symptoms (p=0.11) compared to
those in the treatment-as-usual (TAU) group (Chart 1).
Chart 1: GeneSight Testing Improved Clinical Outcomes for
Patients is available at the following address:
http://www.globenewswire.com/NewsRoom/AttachmentNg/4f6a2a8e-ea5b-410f-8484-9a95ff1365e6
Additionally, these results were durable and continued to
improve through the 24 week follow-up period of the study, with
remission rates doubling to 31 percent, response rates reaching 44
percent, and symptom improvement increasing to 43 percent (Chart
2).
Chart 2: Durable Outcomes that Improved Through the 24
Week Follow-Up Period is available at the following
address:
http://www.globenewswire.com/NewsRoom/AttachmentNg/ffe03f09-bc02-4bb0-87b5-3cbd86bb2002
Furthermore, the study demonstrated that patients have
substantially better outcomes when switched from GeneSight
identified ‘red’ category medications that were incongruent with a
patient’s genetic profile. A subset analysis of the patients who
entered the study on red medications found that those who were
switched to green or yellow category medications by week 8 had 153
percent higher rates of remission (p=0.0067), 71 percent higher
rates of response (p=0.0364), and 59 percent greater symptom
improvement (p=0.0018) compared to those who remained on red
category medications (Chart 3).
Chart 3: Comparison of Outcomes at Week 8 in Patients Who
Entered on ‘Red’ Medications and Were Switched versus Patients
Remaining on ‘Red’ Medications is available at the following
address:
http://www.globenewswire.com/NewsRoom/AttachmentNg/d95d03f7-4917-4493-b603-2b5abadaf3c7
"The consistently strong data supporting GeneSight when compared
to an optimized active drug arm is unprecedented in depression
clinical studies," said Bryan M. Dechairo, Ph.D., executive vice
president of Clinical Development at Myriad Genetics. "The GUIDED
study clearly demonstrates that treatment-resistant patients with
major depressive disorder do better when their therapy selection is
aided by GeneSight."
Investor Conference Call and WebcastA
conference call will be held today, Friday, January 4, 2019, at
4:30 p.m. ET to discuss the GUIDED publication along with the other
supporting clinical evidence for GeneSight. The dial-in
number for domestic callers is 1-800-670-5443. International
callers may dial 1-303-223-4368. All callers will be asked to
reference reservation number 21914017. An archived replay of
the call will be available for seven days by dialing (800) 633-8284
and entering the reservation number above. The conference
call along with a slide presentation will also will be available
through a live webcast at www.myriad.com.
About GeneSightGeneSight is a
laboratory-developed pharmacogenomic test that uses cutting-edge
technology to measure and analyze clinically important genomic
variants in the treatment of psychiatric disorders. The results of
the GeneSight report can help a clinician understand the way a
patient's unique genomic makeup may affect certain psychiatric
drugs. The analysis is based on pharmacogenomics, the study of
genomic factors that influence an individual's response to drug
treatments, manufacturers' FDA approved drug labels, peer reviewed
scientific and clinical publications, and proven drug pharmacology.
Quick turnaround time, combined with a customized report of
the patient's genomic makeup, clinical experience, and other
factors can provide information to help a physician make
personalized drug treatment choices for each patient. For more
information about GeneSight, please visit www.genesight.com.
About Major Depressive DisorderMajor depressive
disorder (MDD) is one of the most common mental disorders and
can result in severe impairments that interfere with or limit one's
ability to carry out major life activities. MDD is defined as
a period of two weeks or longer during which there is either
depressed mood or loss of interest or pleasure, and at least four
other symptoms that reflect a change in functioning, such as
problems with sleep, eating, energy, concentration, self-image or
recurrent thoughts of death or suicide. The National
Institute of Mental Health estimates that more than 16 million
adults in the United States had at least one major depressive
episode in the past year and the World Health Organization (WHO)
categorizes clinical depression as the world's leading cause of
disability.
About Myriad GeneticsMyriad Genetics Inc., is a
leading personalized 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 strategic imperatives: build 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.
Follow Myriad on Twitter via @MyriadGenetics.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
Prelude 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 a conference call being held on Friday,
January 4, 2019, at 4:30 p.m. ET, to discuss the GUIDED publication
along with the other supporting clinical evidence for GeneSight;
the GUIDED study demonstrating that GeneSight improves clinical
outcomes in patients with treatment resistant major depressive
disorder; the GUIDED study representing a major milestone for
Myriad and a significant advance for pharmacogenomic testing;
GeneSight being a clinically proven solution to improve outcomes
for patients with depression; patients having substantially better
outcomes when switched from GeneSight identified ‘red’ category
medications that were incongruent with a patient’s genetic profile;
GeneSight being unprecedented in depression clinical studies when
compared to an optimized active drug arm; the GUIDED study clearly
demonstrating that treatment-resistant patients with major
depressive disorder do better when their therapy selection is aided
by GeneSight; and the Company’s strategic directives under the
captions “About GeneSight” and “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 described or implied in the
forward-looking statements. These risks include, but are not
limited to: the risk that sales and profit margins of our existing
molecular diagnostic tests and pharmaceutical and clinical services
may decline or will not continue to increase at historical rates;
risks related to our ability to transition from our existing
product portfolio to our new tests; risks related to changes in the
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 tests and any future tests are terminated or
cannot be maintained on satisfactory terms; risks related to delays
or other problems with operating our laboratory testing facilities;
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, including
but not limited to our acquisition of Assurex, Crescendo, Sividon
and Counsyl; risks related to our projections about the potential
market opportunity for our products; 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; 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, 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.
Media Contact: |
Ron
Rogers |
Investor Contact: |
Scott Gleason |
|
(801) 584-3065 |
|
(801) 584-1143 |
|
rrogers@myriad.com |
|
sgleason@myriad.com |
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