AnPac Bio-Medical Science Co., Ltd. (Nasdaq:ANPC, “AnPac Bio,” the
“Company” or “we”), a biotechnology company with operations in
China and the United States focused on early cancer screening and
detection, announced today it has achieved a significant milestone
and positive result in its general population cancer risk
assessment tests and subsequent follow-up study on enrolled
individuals whom obtained further check-ups and diagnosis at
healthcare providers using their cancer and disease diagnostic
tools. As of September 30, 2021, healthcare providers have
confirmed 2,067 cancer, pre-cancer, and disease cases, which
includes 22 identified types of cancer, 25 identified types of
pre-cancer, and multiple other related diseases. An initial
analysis showed that confirmed cases are strongly correlated to CDA
test score, confirming that the CDA test is an effective method to
initially screen the population for risks associated with cancer.
AnPac Bio’s follow-up study involved (a) enrolling high, medium,
and low risk groups of individuals based on their CDA test scores
following CDA testing of a large, asymptomatic population, (b)
recommending enrolled individuals to obtain follow-up check-ups at
healthcare providers, (c) following up with enrolled individuals
via phone interviews, and (d) analyzing interview results and data.
As of September 30, 2021, 14,806 individuals in the high, medium
and low risk groups were contacted and interviewed, and 2,067
individuals were confirmed as cancer, pre-cancer or other disease
patients. Based on an initial analysis of the most recent follow-up
data and results, CDA technology is an effective initial screening
tool for asymptomatic general population for multiple cancer types,
pre-cancer types and other related diseases. The confirmed cancer
and pre-cancer cases detected 22 types of cancer and 25 types of
pre-cancer, including esophageal cancer and thyroid cancers that
currently lack effective biomarkers for early screening and
detection.
Distribution of high, medium, and low risk groups based on
CDA tests |
Clinical Status |
High and Medium Risk Group |
Low Risk Group |
Confirmed cancer cases |
99.1% |
0.9% |
Pre-cancer cases |
93.3% |
6.7% |
Confirmed other disease cases |
95.0% |
5.0% |
The top five confirmed cancer types and pre-cancer types are as
follows:
Types of Cancer |
Number of patients |
|
|
Colorectal cancer |
40 |
|
|
Lung cancer |
32 |
|
|
Gastric cancer |
27 |
|
|
Prostate cancer |
24 |
|
|
Breast cancer |
23 |
|
|
Types of pre-cancer |
Number of patients |
|
|
Thyroid nodule/benign tumor |
230 |
|
|
Pulmonary nodule |
179 |
|
|
Lesions of the breast/
Hyperplasia of breast glands |
135 |
|
|
Hysteromyoma |
93 |
|
|
Gastroduodenal diseases |
83 |
The above data demonstrates that CDA technology is also very
effective in finding pre-cancer diseases as confirmed pre-cancer
cases are much higher than those of confirmed cancer cases, which
is very attractive and meaningful for cancer prevention. However,
the confirmed cases are highly likely to be under-reported because
(a) only cases from individuals that we were able to successfully
contact are recorded, (b) some enrolled subjects did not give full
final diagnosis results when contacted, and (c) as an on-going
follow-up study, more confirmed cases will likely be developed and
recorded over time.
Developing a viable pre-cancer and early-stage cancer screening
technology is critical to detect cancer early and to save patient
lives. However, its development and progress has been relatively
slow, despite decades of heavy investments and efforts by leading
scientists and research groups. One of the key factors has been the
lack of leading detection experts to develop sensitive technologies
for low level signal collection and processing. AnPac Bio has built
a unique team of physicists, and experts with extensive experience
from semiconductor and AI-based computational analysis to build the
unique CDA technology platform.
Over the past 12 years, AnPac Bio’s team has innovated and
developed biophysics-based detection technology, in which
biophysical properties of blood are detected and analyzed for
early-stage cancer screening and detection. The Company has been a
staunch champion of the concept of multi-cancer detection through
developing its CDA technology. The measurement of biophysical
properties for cancer detection can detect multiple cancer types
earlier, more cost effectively, with higher sensitivity and
specificity, and through relatively simple sample requirements and
test procedures. These features make AnPac Bio’s CDA technology
perfectly suited for screening general population for cancer
affordably.
Dr. Chris Yu, CEO and Chairman of AnPac Bio commented: “We are
very pleased to reach the milestone of confirming over 2,000 cases
and to achieve significant validation of CDA technology for general
population cancer and pre-cancer risk assessment. This is truly a
breakthrough technology in catching multiple cancer and pre-cancer
types earlier to prevent cancer and provide better patient
outcomes. We are very proud of our contributions to the battle
against cancer and we are contributing to save lives now. We are
already making a significant impact in the fight again cancer
through our innovative ideas (multi-cancer detection), technology
development and finding potential cancer and pre-cancer earlier on
a daily basis. We believe our CDA technology’s results speak for
themselves and expect that public health agencies and organizations
seeking the most promising tools for detecting cancer and
pre-cancer earlier will look closely at AnPac Bio.”
About AnPac Bio
AnPac Bio is a biotechnology company focused on early cancer
screening and detection, with 148 issued patents as of June 30,
2021. With one CLIA and CAP registered clinical laboratory in the
United States and two certified clinical laboratories in China,
AnPac Bio performs a suite of cancer screening and detection tests,
including CDA (Cancer Differentiation Analysis), biochemical,
immunological and genomics tests. According to a Frost &
Sullivan’s report issued in 2020, AnPac Bio ranked third worldwide
among companies offering next-generation early cancer screening and
detection technologies in terms of the number of clinical samples
for cancer screening and detection in 2019. The Company has a
significant cancer screening and detection database consisting of
approximately 43,900 clinical samples as of March 31, 2021. AnPac
Bio’s CDA technology platform has been shown in retrospective
validation studies to be able to detect the risk of over 20
different cancer types with high sensitivity and specificity.
For more information, please visit:
https://www.AnPacBio.com.
For investor and media inquiries, please
contact:
Company:Phil Case, Marketing and Investor RelationsPhone:
+1-267-810-6776 (US)Email: phil_case@AnPacBio.com
Investor Relations:Ascent Investor Relations LLCTina Xiao,
PresidentPhone: +1-917-609-0333
(US)Email: tina.xiao@ascent-ir.com
Safe Harbor Statement
This announcement contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. These forward-looking
statements are made under the “safe harbor” provisions of the
Private Securities Litigation Reform Act of 1995 and are relating
to the Company's future financial and operating performance. The
Company has attempted to identify forward-looking statements by
terminologies including "believes," "estimates," "anticipates,"
"expects," "plans," "projects," "intends," "potential," “target,”
“aim,” “predict,” “outlook,” “seek,” “goal” “objective,” “assume,”
“contemplate,” “continue,” “positioned,” “forecast,” “likely,”
"may," "could," "might," "will," "should," "approximately" or other
words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. These statements are
based on current expectations, assumptions and uncertainties
involving judgments about, among other things, future economic,
competitive and market conditions and future business decisions,
all of which are difficult or impossible to predict accurately and
many of which are beyond the Company's control. These statements
also involve known and unknown risks, uncertainties and other
factors that may cause the Company's actual results to be
materially different from those expressed or implied by any
forward-looking statement. Known and unknown risks, uncertainties
and other factors include, but are not limited to, the
implementation of our business model and growth strategies; trends
and competition in the cancer screening and detection market; our
expectations regarding demand for and market acceptance of our
cancer screening and detection tests and our ability to expand our
customer base; our ability to obtain and maintain intellectual
property protections for our CDA technology and our continued
research and development to keep pace with technology developments;
our ability to obtain and maintain regulatory approvals from the
NMPA, the FDA and the relevant U.S. states and have our
laboratories certified or accredited by authorities including the
CLIA; our future business development, financial condition and
results of operations and our ability to obtain financing
cost-effectively; potential changes of government regulations;
general economic and business conditions in China and elsewhere;
our ability to hire and maintain key personnel; our relationship
with our major business partners and customers; and the duration of
the coronavirus outbreaks and their potential adverse impact on the
economic conditions and financial markets and our business and
financial performance, such as resulting from reduced commercial
activities due to quarantines and travel restrictions instituted by
China, the U.S. and many other countries around the world to
contain the spread of the virus. Additionally, all forward-looking
statements are subject to the “Risk Factors” detailed from time to
time in the Company's most recent Annual Report on Form 20-F and
other filings with the U.S. Securities and Exchange Commission.
Because of these and other risks, uncertainties and assumptions,
undue reliance should not be placed on these forward-looking
statements. In addition, these statements speak only as of the date
of this press release and, except as may be required by law, the
Company undertakes no obligation to revise or update publicly any
forward-looking statements for any reason.
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