Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that new
data comparing BRCA1 and BRCA2 variant classifications between
Myriad Genetics and a commonly used public genetic database was
published in the journal The Oncologist.1 A key finding was
that the public database provided discrepant variant
classifications more than 26 percent of the time, which can
introduce uncertainty and diminish patient care.
The study, done in collaboration with William
Gradishar, M.D., from the Feinberg School of Medicine at
Northwestern University, evaluated 4,250 BRCA1 and BRCA2
variants. Overall, 73.2 percent of variant classifications
analyzed were fully concordant, while 26.7 percent were not.
Most of the discordant classifications had definitive
classifications of pathogenic or benign from Myriad, compared to
“variant of uncertain significance” (VUS) classifications in the
public database.
“The high degree of discordance seen in this
study signals a cautionary note. As a repository of actual
patient results, it means that different labs are providing
different results to patients for the same genetic mutation.
By definition, this means that some patients are receiving
incorrect results that may have life-changing or -threatening
implications,” said Dr. Gradishar. “The discordance observed
within these databases between labs also highlights why public
databases do not accommodate the consistent standard of variant
classification needed for clinical use. Although efforts are
underway to resolve the quality problems within public databases,
it is unlikely the issue will be resolved soon and users of public
databases likely will continue to encounter discrepancies. At
this time, labs should not use public databases in any way in
clinical variant classification.”
These findings are consistent with previously
published studies. A study by Vail et al. compared the
interpretation of more than 2,000 BRCA1/2 variants among five
public databases and found substantial disparity of variant
classifications among and within publicly accessible variant
databases.2 For VUSs in particular, there is no agreement
once the variant is observed in a least four of the five databases
in this study. Another study by Balmana et al. assessed
conflicting interpretations of genetic variants in the Prospective
Registry of Multiplex Testing (PROMPT) and found significant
conflicting interpretations of genetic variants in that
database.3 Specifically, among variants entered into the
PROMPT registry database with classifications from multiple labs,
26 percent had discrepant classifications; 36 percent of which
would affect patient management.
“There are important clinical implications
concerning the high VUS and discordance rates observed in public
databases,” said Johnathan Lancaster, M.D., Ph.D., chief medical
officer, Myriad Genetic Laboratories. “Dr. Gradishar’s findings
reinforce the need for clinical laboratories to invest in
meticulous research so that patients can receive the appropriate
medical interventions. Over the past 25 years, Myriad has
made substantial investments and published more than 8,000
definitively classified variants in peer reviewed publications as
well as the details of our variant classification programs to
advance the science of variant classification.”
A recent study published by Kurian et al. showed
that many surgeons manage patients with BRCA1/2 VUS the same as
patients with BRCA1/2 pathogenic mutations and that half of
average-risk patients with VUS undergo bilateral mastectomy.4
The analysis by Gradishar et al. found that in cases where other
commercial laboratories had a VUS classification in the database,
40 to 60 percent of these variants have a definitive classification
(pathogenic or benign) by Myriad, which may have helped to avoid
many unnecessary surgeries.
Myriad’s ability to more definitively classify
genetic variants stems from its proprietary myVision™ Variant
Classification Program and more than 25-years of experience.
“Variant classification is a complicated
endeavour and multiple studies have shown that it matters when
patients are tested by laboratories that have not invested in the
necessary research but are dependent in part on public databases,”
said Dr. Lancaster. “Myriad is the unquestioned leader in
genetic testing for hereditary cancers. Over the last 25-years,
Myriad has delivered millions of test results, which means the
myVision program is based on the largest and most robust database
in the industry to identify, classify, and assign clinical
significance to genetic variants.”
Key features of the myVision variant
classification program include:
- Classification by industry-leading experts. The Myriad Variant
Classification Program consists of a large and diverse team of
scientists with hundreds of years of cumulative experience who
determine the clinical significance of variants.
- Innovative and exclusive technologies. myVision employs
cutting-edge statistical techniques developed after testing more
than 500,000 patients. And, we continue to evaluate variants over
time as new data and technology become available.
- Dramatically declining VUS rates. Myriad has reduced the
BRCA1/2 VUS rates from 40 percent to 1.6 percent, dramatically
lower than any other laboratory.
- Reviewed by the U.S. Food and Drug Administration. as
a part of the BRACAnalysis CDx premarket approval
submission.
- Lifetime commitment to every patient tested. When a VUS is
reclassified as clinically actionable in the future, an amended
report will be made available to the patient, which is unique to
Myriad’s program.
Follow Myriad Genetics on Twitter via @MyriadGenetics to stay
informed about news and updates about the Company.
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 discrepant variant classifications in public
databases and the resulting impact on patient care; the timing as
to when this issue will be resolved; the likelihood that users of
public databases will continue to encounter discrepancies; whether
labs should be using public databases in any way in clinical
variant classification; the implications concerning the high VUS
and discordance rates observed in public databases; 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.
____________________
1 Gradishar W, Johnson K, Brown K, et al: Clinical Variant
Classification: A Comparison of Public Databases and a Commercial
Testing Laboratory. The Oncologist. April 12,
2017. Accessed online at:
http://theoncologist.alphamedpress.org/.
2 Vail PJ, Morris B, vanKan A, et al: Comparison of
locus-specific databases for BRCA1 and BRCA2 variants reveals
disparity in variant classification within and among databases. J
Community Genet 6:351-359, 2015.
3 Balmana J, Digiovanni L, Gaddam P, et al: Conflicting
interpretation of genetic variants and cancer risk by commercial
laboratories as assessed by the Prospective Registry of Multiplex
Testing. J Clin Oncol 34:4071-4078, 2016.
4 Kurian A, Li Y, Hamilton A, et al: Gaps in Incorporating
Germline Genetic Testing Into Treatment Decision-Making for
Early-Stage Breast Cancer. April 12, 2017.
Accessed online at: www.jco.org.
Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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