MADISON, Wis., May 29, 2020 /PRNewswire/ -- Exact
Sciences Corp. (NASDAQ: EXAS) today announced it is presenting new
data at the 2020 American Society of Clinical Oncology (ASCO20)
Virtual Scientific Program. These data further demonstrate the
clinical value of the Oncotype DX Breast Recurrence
Score® test and exemplify the research progress
made by Exact Sciences' Mayo Clinic collaboration toward smarter
solutions across the cancer continuum.
Three studies of the Oncotype DX Breast Recurrence
Score® test presented at ASCO20 highlight the value
that the Oncotype DX® test can provide by personalizing
and improving neoadjuvant treatment decisions (i.e., prior to
surgery) in women with hormone receptor positive, HER2-negative
breast cancer.
The new data at ASCO20 add to existing evidence1,2,3
and reinforce the value of the Oncotype DX test in light of recent
COVID-19 pandemic recommendations.4,5
"As health systems across the world respond to the COVID-19
pandemic, both cancer screenings and elective surgeries are being
postponed," said Dr. Anthony Lucci,
professor of Breast Surgical Oncology at MD Anderson Cancer Center.
"Based on the new data presented at ASCO20, the Oncotype DX test
identified women with a low likelihood of responding to neoadjuvant
chemotherapy, who may benefit from alternative approaches while
awaiting surgery, such as neoadjuvant endocrine therapy at home.
This approach could overcome some of the unique challenges we and
our patients are currently facing during this public health
crisis."
Response to neoadjuvant chemotherapy and the 21-gene Breast
Recurrence Score in young women with estrogen receptor-positive
early breast cancer
Abstract Number: 514
This study included 76 women treated with neoadjuvant chemotherapy
from the Young Women's Breast Cancer Study, a multi-center
prospective group of women diagnosed with breast cancer at age 40
or younger. The Oncotype DX test was performed on tumor specimens
from core biopsies obtained from the patients prior to surgery.
Results revealed that patients with a higher Recurrence Score
result were more likely to achieve a pathologic complete response
(pCR; no residual invasive tumor) with chemotherapy.
21-gene Recurrence Score assay as a predictor of pathological
response in neoadjuvant chemotherapy administration for
ER-positive/HER2-negative early-stage breast
cancer
Abstract Number: e12630
Conducted in Spain, this study
prospectively analyzed a group of 63 patients who received
neoadjuvant chemotherapy after the Oncotype DX test was performed
on tumor specimens from core biopsies. The analysis showed a strong
correlation between pCR and Recurrence Score result. In particular,
the Recurrence Score result was the most significant predictor of
pCR when compared to other factors such as Ki67 (a classic
prognostic factor), estrogen receptor status, and initial tumor
size.
Prediction of response to neoadjuvant hormonal therapy (NAHT)
using upfront Oncotype DX Breast Recurrence Score (RS): results
from the SAFIA phase III trial
Abstract Number:
594
In this study, the Oncotype DX test was performed prior to surgery
and patients with Recurrence Score results 0-30 received
neoadjuvant endocrine therapy without chemotherapy. After four
months of treatment, data from 142 patients showed that 97% of them
had a clinical response or stable disease, suggesting that patients
with a Recurrence Score result <31 can be offered neoadjuvant
endocrine therapy alone with minimal risk of progression of
disease.
Additional Abstracts Highlight Progress in Research and
Development
Through a longstanding collaboration, researchers at Exact
Sciences and Mayo Clinic continue to identify biomarkers associated
with some of the deadliest forms of cancer. Abstracts accepted for
presentation at ASCO20, including promising results in five
different cancer types, are highlighted below.
Algorithm for blood-based panel of methylated DNA and protein
markers to detect early-stage hepatocellular carcinoma (HCC) with
high specificity
Abstract Number: 4577
A robust algorithm based on novel blood-based biomarkers provided
higher sensitivity for early-stage HCC (70%) compared to other
available blood-based methods (54% and 52%) and, therefore, could
significantly impact HCC clinical management and patient
outcomes.
Molecular detection of pancreatic neuroendocrine tumors using
methylated DNA markers: discovery and tissue validation
Abstract Number: e16705
Four novel methylated DNA markers accurately discriminated
pancreatic neuroendocrine tumors from controls with normal pancreas
and buffy coat (≥ 95% accuracy for each marker). These markers also
differentiated metastatic pancreatic neuroendocrine tumors from
normal pancreas tissue.
Novel methylated DNA markers in plasma detect distant
recurrence of colorectal cancer
Abstract Number:
4088
A panel of novel methylated DNA markers in plasma detected distant
recurrent colorectal cancer with promising accuracy (96% in liver
metastases, 78% in lung metastases, and 57% in peritoneal/nodal
metastases). These data are a positive early signal for the
clinical utility of methylated DNA markers for non-invasive
post-treatment surveillance and treatment monitoring in colorectal
cancer.
Methylated DNA markers for plasma detection of ovarian
cancer: discovery, validation, and clinical
feasibility
Abstract Number: 6072
Whole methylome sequencing, stringent filtering criteria, and
biological validation yielded candidate methylated DNA markers for
ovarian cancer that performed with promisingly high sensitivity and
specificity in plasma (79% sensitivity at 96% specificity). These
data indicate that larger plasma-based ovarian cancer methylated
DNA marker testing studies are warranted.
Methylated DNA marker panel for metastatic melanoma:
discovery and tissue validation
Abstract Number:
e22024
A panel of five novel methylated DNA markers assayed on tissue and
undetectable in normal buffy coat achieved a very high
discrimination between melanoma and benign control tissues (94% for
metastatic melanoma and 85% for primary melanoma). This panel can
be assessed in blood or other bodily fluids for application in
melanoma surveillance.
ASCO20 will be conducted May 29-31,
2020.
About Oncotype DX
The Oncotype DX portfolio of breast,
colon and prostate cancer tests applies advanced genomic science to
reveal the unique biology of a tumor in order to optimize cancer
treatment decisions. In breast cancer, the Oncotype DX Breast
Recurrence Score test is the only test that has been shown to
predict the likelihood of chemotherapy benefit as well as
recurrence in invasive breast cancer. Additionally, the Oncotype DX
Breast DCIS Score test predicts the likelihood of recurrence in a
pre-invasive form of breast cancer called DCIS. In prostate cancer,
the Oncotype DX Genomic Prostate Score® test predicts
disease aggressiveness and further clarifies the current and future
risk of the cancer prior to treatment intervention, and the
Oncotype DX AR-V7 Nucleus Detect™ test helps determine
which patients with metastatic castration-resistant prostate cancer
(mCRPC) are resistant to androgen receptor (AR)-targeted therapies.
The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic
Sciences at its centralized, CLIA-certified laboratory in
San Diego and offered exclusively
by Exact Sciences. With more than 1 million patients tested in more
than 90 countries, the Oncotype DX tests have redefined
personalized medicine by making genomics a critical part of cancer
diagnosis and treatment. To learn more about Oncotype DX tests,
visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org 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: Oncotype, Oncotype DX, Breast Recurrence Score are
trademarks or registered trademarks of Genomic Health, Inc. Exact
Sciences is a trademark or registered trademark of Exact Sciences
Corporation. All other trademarks and service marks are the
property of their respective owners.
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 Iwata H, et al. Breast Can Res Treat. 2019.
2 Pivot X, et al. Oncologist. 2015.
3 Kantor O, et al. Ann Surg Oncol. 2019.
4 Dietz JR, et al representing the COVID-19 Pandemic
Breast Cancer Consortium. Breast Can Res
Treat. 2020
5
https://www.esmo.org/guidelines/cancer-patient-management-during-the-covid-19-pandemic/breast-cancer-in-the-covid-19-era.
Investors:
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Media (U.S.):
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Media (Canada,
Europe, Asia, Latin America):
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Megan
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Stephanie Spanos
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Federico
Maiardi
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+1
608-535-8815
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608-556-4380
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+41
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fmaiardi@exactsciences.com
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