MADISON, Wis., June 16, 2020 /PRNewswire/ -- Exact Sciences
Corp. (NASDAQ: EXAS) today announced the publication of results
highlighting the performance of the Oncotype DX Genomic
Prostate Score® (GPS™) result in patients with
unfavorable intermediate (UFI)-risk prostate cancer. Published in
Urology, the new results demonstrate the GPS test is a
strong independent predictor of critical outcomes in UFI-risk
prostate cancer patients.
"While men with very low-, low- and favorable intermediate-risk
prostate cancer often choose between active surveillance and
treatment, men with unfavorable intermediate-risk disease must make
decisions about how aggressive their treatment plan should be,"
said Jennifer Cullen, Ph.D., M.P.H.,
lead author of the publication and Associate Director of Cancer
Population Sciences at the Case Comprehensive Cancer Center in
Cleveland. "These new findings,
which demonstrate for the first time the GPS test as a strong
predictor of critical endpoints in UFI-risk disease, indicate that
Oncotype DX® testing can aid physicians and UFI-risk
prostate cancer patients in their decision-making process. The GPS
score may help in decisions regarding treatment intensity and
empower patients in their care choices."
For this new publication, additional statistical analyses were
conducted of GPS results from two previously published cohort
studies in men treated with radical prostatectomy. The study
included 299 intermediate-risk patients, 175 of whom were
classified as UFI-risk. Results showed that UFI-risk patients with
a GPS test result >40 had outcomes consistent with high-risk
disease and a poor prognosis, indicating they may benefit from more
aggressive therapies. In contrast, UFI-risk patients with a GPS
value <40 had outcomes similar to favorable intermediate-risk
patients, suggesting less aggressive therapy may be needed.
The GPS test has been shown in multiple studies to be a strong
independent predictor of several critically important outcomes in
men with very low, low, and favorable intermediate-risk prostate
cancer. Findings from these new analyses support guideline
inclusion of the GPS test in the broader population of UFI-risk
patients.1
"Men and families facing a prostate cancer diagnosis have many
questions and tough decisions in determining the best course of
treatment. Tools like the GPS test can help patients have
confidence in navigating a treatment pathway," said Jamie
Bearse, chief executive officer of ZERO - The End of Prostate
Cancer. "This is an important step forward for expanding access and
coverage for intermediate-risk prostate cancer patients, as they
can use the GPS test to help best guide and determine their
treatment."
About the Oncotype DX Genomic Prostate
Score® (GPS™) Test
Developed by Genomic Health, a wholly-owned subsidiary of
Exact Sciences Corp., and based on results from multiple studies
led by Cleveland Clinic and the University of
California, San Francisco, the Oncotype DX® GPS test
is the only genomic assay designed for men with clinically low-risk
or favorable intermediate-risk cancer to help make treatment
decisions at the time of diagnosis. The test analyzes 17 genes
across four biological pathways from tumor tissue removed during
biopsy to provide a GPS result with a score ranging from 0-100 that
corresponds to the biologic aggressiveness of the tumor and the
patient's likelihood of prostate cancer metastasis and death at 10
years. The GPS test is included within NCCN
Guidelines® as a Category 2A molecular testing
option for consideration in prostate cancer patients with
clinically low-risk and favorable intermediate-risk disease and is
covered by Medicare and multiple private insurance
companies in the United
States. To learn more about the Oncotype DX Genomic Prostate
Score test,
visit www.OncotypeIQ.com or www.MyProstateCancerTreatment.org.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests,
Exact Sciences relentlessly pursues smarter solutions providing the
clarity to take life-changing action, earlier. Building on the
success of the Cologuard® and Oncotype DX tests, Exact
Sciences is investing in its product pipeline to take on some of
the deadliest cancers and improve patient care. Exact Sciences
unites visionary collaborators to help advance the fight against
cancer. For more information, please visit the company's website
at www.exactsciences.com, follow Exact Sciences on Twitter
@ExactSciences, or find Exact Sciences on Facebook.
NOTE: In the US and certain other jurisdictions, Genomic
Health, Oncotype, Oncotype DX, Oncotype IQ, Breast Recurrence
Score, Recurrence Score, DCIS Score, Colon Recurrence Score,
Genomic Prostate Score, GPS, AR-V7 Nucleus Detect, Pass It On:
Until Every Woman Knows, and Making Cancer Care Smarter are
trademarks of Genomic Health, Inc., an Exact Sciences
corporation.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of
1934, as amended, that are intended to be covered by the "safe
harbor" created by those sections. Forward-looking statements,
which are based on certain assumptions and describe our future
plans, strategies and expectations, can generally be identified by
the use of forward-looking terms such as "believe," "expect,"
"may," "will," "should," "would," "could," "seek," "intend,"
"plan," "goal," "project," "estimate," "anticipate" or other
comparable terms. All statements other than statements of
historical facts included in this news release regarding our
strategies, prospects, expectations, financial condition,
operations, costs, plans and objectives are forward-looking
statements. Examples of forward-looking statements include, among
others, statements we make regarding expected future operating
results, anticipated results of our sales, marketing and patient
adherence efforts, expectations concerning payer reimbursement, and
the anticipated results of our product development
efforts. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
only on our current beliefs, expectations and assumptions regarding
the future of our business, future plans and strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Actual results, conditions and
events may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause actual results, conditions and events to differ materially
from those indicated in the forward-looking statements include,
among others, the following: uncertainties associated with the
coronavirus (COVID-19) pandemic, including its possible effects on
our operations and the demand for our products and services; our
ability to efficiently and flexibly manage our business amid
uncertainties related to COVID-19; our ability to successfully and
profitably market our products and services; the acceptance of our
products and services by patients and healthcare providers; our
ability to meet demand for our products and services; the success
of our efforts to facilitate patient access to Cologuard via
telehealth; the willingness of health insurance companies and other
payers to cover our products and services and adequately reimburse
us for such products and services; the amount and nature of
competition for our products and services; the effects of the
adoption, modification or repeal of any law, rule, order,
interpretation or policy relating to the healthcare system,
including without limitation as a result of any judicial, executive
or legislative action; the effects of changes in pricing, coverage
and reimbursement for our products and services, including without
limitation as a result of the Protecting Access to Medicare Act of
2014; recommendations, guidelines and quality metrics issued by
various organizations such as the U.S. Preventive Services Task
Force, the American Society of Clinical Oncology, the American
Cancer Society, and the National Committee for Quality Assurance
regarding cancer screening or our products and services; our
ability to successfully develop new products and services and
assess potential market opportunities; our ability to effectively
enter into and utilize strategic partnerships, such as through our
Promotion Agreement with Pfizer, Inc., and acquisitions; our
success establishing and maintaining collaborative, licensing and
supplier arrangements; our ability to maintain regulatory approvals
and comply with applicable regulations; our ability to manage an
international business and our expectations regarding our
international expansion and opportunities; the potential effects of
foreign currency exchange rate fluctuations and our efforts to
hedge such effects; the possibility that the anticipated benefits
from our combination with Genomic Health cannot be realized in full
or at all or may take longer to realize than expected; the
possibility that costs or difficulties related to the integration
of Genomic Health's operations will be greater than expected and
the possibility of disruptions to our business during integration
efforts and strain on management time and resources; the outcome of
any litigation, government investigations, enforcement actions or
other legal proceedings; and the other risks and uncertainties
described in the Risk Factors and in Management's Discussion and
Analysis of Financial Condition and Results of Operations sections
of our most recently filed Annual Report on Form 10-K and our
subsequently filed Quarterly Reports on Form 10-Q. We undertake no
obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
1 Cullen J, Kuo HC, Shan J, et al. The 17-Gene
Genomic Prostate Score Test as a Predictor of Outcomes in Men with
Unfavorable Intermediate Risk Prostate Cancer. Urol. 2020 (In
Press)
Investors:
|
Media:
|
Megan
Jones
|
Stephanie
Spanos
|
608-535-8815
|
608-556-4380
|
meganjones@exactsciences.com
|
sspanos@exactsciences.com
|
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