AnPac Bio Class III Medical Device Passes Extensive NMPA Registration Tests and Will Start Clinical Trial in Q1, 2022
04 January 2022 - 11:30PM
AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or
“we”) (ANPC), a US and China-based biotechnology company focused on
early cancer screening and detection, announced today that on
December 30, 2021, the Company’s Class III medical device for lung
cancer auxiliary diagnosis has completed and passed stringent and
rigorous registration tests at the testing laboratory designated by
the National Medical Products Administration (NMPA), China’s
regulatory agent for medical products. China’s extensive Class III
medical device registration tests included medical device
performance tests related to accuracy, precision, stability,
linearity, accuracy and repeatability in sample addition,
cross-contamination, electromagnetic compatibility (EMC), and
reliability and performance under various environmental conditions.
Completion of the NMPA registration tests is a significant
milestone toward obtaining a Class III medical device registration
certificate. Following completion of the registration test, the
remaining major step prior to final approval of a registration
certificate will be clinical trials which will begin in the first
quarter of 2022 with two qualified clinical trial medical
institutions.
AnPac Bio began its official medical device
registration process in December 2018 by filing an application for
medical device classification with the NMPA. Since then, AnPac Bio
has obtained the determination of the product classification
(recommended as Class III) from the NMPA, carried out significant
medical device optimization, completed rigorous internal medical
device testing, undergone extensive external third-party testing
and validation, and received a certificate of designated inspection
capability from the designated medical device registration test
laboratory.
The above-mentioned Class III medical device
designation is based on AnPac Bio’s novel cancer differentiation
analysis (CDA) technology, which has been used in cancer risk
assessment tests for general population and clinical studies and
has already accumulated more than 240,000 samples including general
population screening, as well as extensive retrospective and
prospective clinical studies with leading medical institutions. If
AnPac Bio is successful in obtaining the Class III registration
certificate from the NMPA for its CDA device, it will add
additional markets and channels for the Company to sell its tests.
AnPac Bio will be able to penetrate the medical segment of the
market, including hospitals and medical institutions for lung
cancer auxiliary diagnosis tests, which is a significant market,
and can further fuel the Company’s revenue growth.
Dr. Chris Yu, CEO and Chairman of AnPac Bio
commented: “We are very excited about this significant milestone
and major accomplishment. By passing this challenging and rigorous
medical device registration test, we have demonstrated our
technical and commercialization capabilities. Lung cancer is a
major cancer and there are very few approved registration
certificates for lung cancer, so obtaining a Class III medical
device registration certificate for lung cancer auxiliary diagnosis
would enhance our competitive position in the marketplace and
position us for increased revenues. This is one of AnPac Bio’s most
important projects, along with our plan to commercialize and market
our CDA test as a laboratory developed test (LDT) in the United
States. We now expect significant further progress in obtaining
Class III medical device registration certificate in China and LDT
in the US in 2022.”
About AnPac BioAnPac Bio is a
biotechnology company focused on early cancer screening and
detection, with 150 issued patents as of September 30, 2021. With
two certified clinical laboratories in China and one CLIA and CAP
accredited clinical laboratory in the United States, AnPac Bio
performs a suite of cancer screening and detection tests, including
CDA (Cancer Differentiation Analysis), bio-chemical, immunological,
and genomics tests. According to Frost & Sullivan, 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,
based on approximately 43,980 clinical samples as of September 30,
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 and registration certificates 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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