First analysis from ASCEND-2 confirms high
detection rates and specificity achieved with multi-biomarker
approach in most aggressive cancers and those with no
standard-of-care screening test1
Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of
cancer screening and diagnostic tests, will present late-breaking
data from the first analysis of the ASCEND-2 study demonstrating
the compelling performance of its investigational multi-biomarker
class, multi-cancer early detection (MCED) blood test. These
results validate the sensitivity and specificity of the company’s
multi-biomarker class approach across a broad range of cancer
types, including the most aggressive cancers and cancers with no
current standard of care for screening. ASCEND-2 is a large,
multi-center, prospective, case-control study of over 11,000
clinically characterized participants from a racially, ethnically,
and geographically diverse cohort representative of the U.S.
population. These data will be presented at the American
Association for Cancer Research® (AACR) Annual Meeting 2024, April
5-10 in San Diego, California.1
“Cancer is the second-leading cause of death in the U.S., and
while early detection is associated with longer survival,
two-thirds of deaths are caused by cancers that lack standard
screening tests. MCED tests have the potential to revolutionize
cancer screening by enabling us to spot more cancers and intervene
earlier,” said Tom Beer, MD, Chief Medical Officer, Multi-Cancer
Early Detection, Exact Sciences.2-4 “This analysis from ASCEND-2
confirms that our multi-biomarker class approach to MCED test
design may deliver benefits beyond what is currently achievable.
The sensitivity and specificity achieved in the detection of the
most aggressive cancers and those cancers with no current standard
of care provide the confidence to move forward to a real-world
evidence study.”
Exact Sciences will also present new outcomes data from
DETECT-A, the first large prospective study of an earlier
multi-biomarker class MCED test that enrolled more than 10,000
participants with more than four years of follow-up.5
The abstracts featured at AACR 2024 are as follows:
Title: Performance of a multi-analyte, multi-cancer early
detection (MCED) blood test in a prospectively collected cohort
Presenter: Diehl, F Session: Monday, April 8, 9:00
a.m. – 12:30 p.m. PDT (Session LBPO.CL01) Poster number:
LB100/11 Location: Section 51 Key findings: First
analysis of the refined multi-biomarker class MCED test achieved an
overall sensitivity of 50.9% with 98.5% specificity and 56.8%
sensitivity when breast and prostate cancer were excluded from the
analysis. Sensitivity was 54.8% for cancers without
standard-of-care screening for average-risk populations and 63.7%
in the most aggressive cancers with the shortest 5-year survival
rate (pancreas, esophagus, liver, lung and bronchus, stomach, and
ovary).
Title: Case report: DETECT-A participants with
pre-malignant conditions Presenter: Rego, SP Session:
Monday, April 8, 9:00 a.m. – 12:30 p.m. PDT (Session PO.CL01.16)
Poster number: 2449/14 Location: Section 41 Key
findings: Results showed that in the rare instance when MCED
testing detected pre-cancerous conditions in the DETECT-A study,
surgical interventions prevented cancer development, and all
patients were cancer-free at follow-up.
About the ASCEND-2 study
The ASCEND-2 (Ascertaining Serial Cancer patients to Enable New
Diagnostic 2) study is a large, multi-center, prospective,
case-control study of clinically characterized participants. Key
goals of the study are to develop the algorithm and identify the
biomarkers to inform the final design of the Cancerguard™ test,
Exact Sciences’ investigational, multi-biomarker class blood-based
MCED test. ASCEND-2 has enrolled over 11,000 participants across
151 sites within the U.S. and Europe. The study population includes
male and female subjects 50 years and over with known cancer,
suspicion of cancer, and controls without cancer. ASCEND-2 selected
cancer types in an incidence-targeted manner, including rare and
common cancers and evenly distributed stages. By enrolling
racially, ethnically, and geographically diverse participants, the
study enables MCED test development with a widely representative
cohort.
About the DETECT-A study
The DETECT-A (Detecting cancers Early Through Elective
mutation-based blood Collection and Testing) study was the
first-ever large, prospective, interventional study to use a blood
test to detect multiple types of cancer in a real-world setting.
The DETECT-A study enrolled more than 10,000 women with no history
of cancer to determine if a blood test in combination with
standard-of-care screenings could detect cancers before signs and
symptoms appeared. The CancerSEEK test, the MCED test studied in
DETECT-A, was the forerunner to the Cancerguard test, the MCED test
currently in development at Exact Sciences.
About the Cancerguard™ test
The Cancerguard test, currently in development, is designed to
detect multiple cancers in their earliest stages from a single
blood draw. Building upon decades of research, Exact Sciences
intends to harness the additive sensitivity of multiple biomarker
classes to detect more cancers in earlier stages. The Cancerguard
test will utilize a streamlined and standardized imaging-based
diagnostic pathway, which may result in fewer follow-up procedures.
The test is being developed to provide high specificity to help
minimize false positives while detecting multiple cancers,
including those with the biggest toll on human health. The
Cancerguard test is currently under development. These features
describe current development goals. The Cancerguard test has not
been cleared or approved by the U.S. Food and Drug Administration
or any other national regulatory authority. To learn more, visit
http://www.exactsciences.com/cancerguard.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests,
Exact Sciences gives patients and healthcare professionals the
clarity needed to take life-changing action earlier. Building on
the success of the Cologuard® and Oncotype® tests, Exact Sciences
is investing in its pipeline to develop innovative solutions for
use before, during, and after a cancer diagnosis. For more
information, visit ExactSciences.com, follow Exact Sciences on X
(formerly known as Twitter) @ExactSciences, or find Exact Sciences
on LinkedIn and Facebook.
Exact Sciences, Cologuard, and Cancerguard are trademarks of
Exact Sciences Corporation. Oncotype is a trademark of Genomic
Health, Inc., a wholly-owned subsidiary of Exact Sciences
Corporation.
Forward-looking statements
This news release contains forward-looking statements concerning
our expectations, anticipations, intentions, beliefs, or strategies
regarding the future. These forward-looking statements are based on
assumptions that we have made as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions, and events to differ materially from
those anticipated. Therefore, you should not place undue reliance
on forward-looking statements. Examples of forward-looking
statements include, among others, statements we make regarding the
development and commercialization of the Cancerguard test; the
performance characteristics and healthcare benefits of the
Cancerguard test; and the timing and anticipated results of FDA or
any other national regulatory authority submission. Risks and
uncertainties that may affect our forward-looking statements are
described in the Risk Factors sections of our most recent Annual
Report on Form 10-K and any subsequent Quarterly Reports on Form
10-Q, and in our other reports filed with the Securities and
Exchange Commission. 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.
References
- Gainhullin V., et. al. Abstract #LB100/11, AACR 2024.
- American Cancer Society. Cancer facts and figures 2024.
Accessed April 3, 2024.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf
- Hawkes, N. Cancer survival data emphasise importance of early
diagnosis. BMJ. 2019; doi:10.1136/bmj.l408
- Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA
Cancer J Clin. 2024; doi:10.3322/caac.21820
- Choudhry, O., et. al. Abstract #2449/14, AACR 2024.
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version on businesswire.com: https://www.businesswire.com/news/home/20240408436394/en/
Media (U.S.): Morry Smulevitz +1 608-345-8010
msmulevitz@exactsciences.com
Media (Outside the US): Federico Maiardi +41 79-138-1326
fmaiardi@exactsciences.com
Investors: Nathan Harrill +1 608 535-8659
investorrelations@exactsciences.com
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