Pivotal Study Results for Myriad’s myPath® Melanoma Test Highlighted In Two Additional Scientific Publications
April 05 2017 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that it has
published the third clinical validation study and second clinical
utility study for its myPath
® Melanoma test, which
completes the reimbursement dossier for the product.
The Company also announced it will submit the reimbursement dossier
to Medicare and private insurers three months earlier than
expected. myPath Melanoma is an objective genetic test that
measures 23 genes to help differentiate malignant
melanoma from benign lesions.
“The pivotal results from these two studies join
a number of additional publications, which is the culmination of
five years of extensive scientific research and innovation,” said
Vicki Fish, vice president, Dermatology Business Unit, Myriad
Genetic Laboratories. “We believe that our reimbursement
dossier is exceptionally strong, and we will work with health plans
to ensure this test is widely accessible to the physicians and
patients who need it.”
The third clinical validation titled “Diagnostic
Distinction of Malignant Melanoma and Benign Nevi by a Gene
Expression Signature and Correlation to Clinical Outcomes” was
published in the journal Cancer Epidemiology, Biomarkers &
Prevention. The study assessed the performance of the myPath
Melanoma test in an independent cohort of 182 patients with
melanocytic lesions against clinically proven outcomes (99 primary
melanomas with distant metastases and 83 benign moles). The
median time to melanoma metastasis was 18 months and the median
follow-up time for benign moles was 75 months. The results
showed that the myPath Melanoma test had an overall diagnostic
accuracy of 95 percent to effectively differentiate melanoma from
benign lesions. These strong findings demonstrate that the
myPath Melanoma test closely correlates with long-term clinical
outcomes and adds valuable information to assist in the accurate
diagnosis of melanoma.
The second clinical utility study titled “The
Influence of a Gene Expression Signature on the Treatment of
Diagnostically Challenging Melanocytic Lesions” was published in
the journal Personalized Medicine. This study was designed to
evaluate changes in real world patient management based upon the
myPath Melanoma test result. Samples from 77 patients with
suspicious skin lesions (i.e., melanocytic neoplasms) were tested
using the myPath Melanoma test accompanied by pre-test
documentation of the intended treatment recommendations. The
actual treatment provided by dermatologists was then documented
after testing. The results showed there was a 71 percent
change in patient management from pre-test recommendations and an
81 percent reduction in biopsy site re-excisions for patients with
a benign test result. Based on these findings, the myPath
Melanoma test significantly influenced the physicians’ treatment of
patients.
A list of the key analytic validation, clinical
validation and clinical utilities studies that comprise the myPath
Melanoma reimbursement dossier follows below.
Key Elements of myPath Melanoma Reimbursement
Dossier
Study |
Key Result |
Peer-Reviewed Publication |
Clinical Validation 1 (n=437) |
• >90 percent diagnostic accuracy |
Journal of Cutaneous Pathology (2015) |
Clinical Validation 2 (n=736) |
• >91 percent diagnostic accuracy |
Cancer (2016) |
Clinical Validation 3 (n=182) |
• >95 percent diagnostic accuracy |
Cancer Epidemiology, Biomarkers & Prevention (2017) |
Analytic Validation (n=544) |
• Only 2.5 percent standard deviation of the score High dynamic
range, precision, RNA yield |
Biomarkers in Medicine (2015) |
Clinical Utility 1 ( n=218) |
• >50 percent increase in definitive diagnoses for cases that
were originally diagnosed as indeterminate. • ~50 percent change in
treatment recommendations for diagnostically challenging
cases. |
Medicine (2016) |
Clinical Utility 2 (n=77) |
• 71 percent change in patient management from pre-test
recommendations• 81 percent reduction in excisions for patients
with a benign test. |
Personalized Medicine (2017) |
Health Economic |
• 8.3 percent reduction in 10-year costs per patient.• Savings of
$.067 per member per month. |
Journal of Medical Economics (2014). |
|
|
|
”Melanoma is one of the fastest growing cancers in the United
States, and there is demand among physicians for an objective, high
quality, clinically validated molecular diagnostic test to be used
as an adjunct to conventional tools like the microscope,” said
Loren Clarke, M.D., board-certified dermatopathologist and medical
director, Dermatology, Myriad Genetic Laboratories. “We
believe myPath Melanoma is one of the most studied and accurate
molecular diagnostic tests ever developed. It has enormous
potential to help save the lives of people with melanoma, spare
people with benign moles from unneeded treatment and lower costs
for our healthcare system.”
Follow Myriad on Twitter via @MyriadGenetics to stay informed
about news and updates about myPath Melanoma from the Company.
About MelanomaMelanoma is one of the fastest
growing cancers in the United States and can strike people of all
ages, races and skin types. With a one-in-50 lifetime risk of
developing melanoma, nearly 87,000 Americans are expected to be
diagnosed with Stage I-IV melanoma and another 75,000 will be
diagnosed with melanoma in situ – totaling approximately
162,000 total diagnoses. Early and accurate diagnosis of
melanoma is critical for long-term survival. For more
information visit: www.mypathmelanoma.com/.
About Myriad
myPath® Melanoma
Myriad myPath Melanoma is a clinically validated test to be used as
an adjunct to histopathology when the distinction between a benign
nevus and a malignant melanoma cannot be made confidently by
histopathology alone. The test measures the expression of 23 genes
and accurately distinguishes melanoma from benign nevi.
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
three strategic imperatives: transitioning and expanding its
hereditary cancer testing markets, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. 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 and Prolaris 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 publication of the third clinical validation
study and second clinical utility study for the myPath Melanoma
test; the Company’s plans and timing to seek reimbursement from
Medicare and private payers; the ability of the myPath Melanoma
test to differentiate malignant melanoma from benign lesions with
95 percent diagnostic accuracy; the ability of the myPath Melanoma
test to closely correlate with long-term clinical outcomes; the
ability of the myPath Melanoma test to significantly influence
physicians’ treatment of patients; 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 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 our 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,
Sividon and the Clinic; 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 Annual report on Form 10-K for the fiscal year ended
June 30, 2016, 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
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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