AnPac Bio US Completes COVID-19 Antibody Test Verification and Approved to Begin Commercial Testing

Rhea-AI Summary

AnPac Bio-Medical Science Co. has completed the FDA EUA verification for its COVID-19 antibody test at its San Jose lab, marking its first commercialized test in the U.S. The company also installed the necessary equipment in its Philadelphia lab. This achievement underlines AnPac Bio's commitment to developing COVID-19 testing solutions amid rising cases. Additionally, the firm continues to prioritize cancer screening tests, currently working on the registration of its Cancer Differentiation Analysis (CDA) technology in China and validation in the U.S.

Positive

• Completion of FDA EUA verification for COVID-19 antibody test boosts credibility and market access.
• Installation of testing equipment in Philadelphia enhances operational capacity.
• Initiating commercialization in the U.S. paves the way for potential revenue generation.

Negative

• None.

SAN JOSE, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (NASDAQ: ANPC), a biotechnology company with operations in China and the United States announced today that the Company has completed an FDA EUA- SARS-CoV-2 (COVID-19) antibody test verification in its San Jose, California lab in November 2020 for the Roche Elecsys Anti Sars-COV-2 test, and is now capable of entering into the commercial testing stage. The Company also announced that COVID-19 antibody test equipment has also completed installation in its Philadelphia lab.

Anpac Bio has been focused on developing and commercializing COVID-19 TEST products and services in both US and China. With COVID-19 cases still on the rise and no clear short-term and intermediate containment measures in sight, COVID-19 tests will likely become long-term and widely-needed viable tests. In addition, COVID-19 antibody testing will likely become increasingly valuable as one measure of the potential effectiveness of COVID-19 vaccines, and in assisting employers on ensuring office safety and productivity. Along with AnPac Bio’s vision and goal of developing and offering new test products and services, the Company is fully committed to qualifying and commercializing COVID-19 tests in both the US and China.

Verification and commercialization of COVID-19 antibody tests in the US is a major milestone for AnPac Bio, as this is the very first commercialized test in the US by the Company. In addition, the COVID-19 antibody tests will also be offered in the Company’s Philadelphia lab, where COVID-19 antibody test equipment has been installed for COVID-19 antibody tests, after meeting all proper requirements in the first half of 2021.

In addition to COVID-19 test products and services, the Company’s top priority is still commercializing cancer screening tests and a medical device, namely cancer differentiation analysis (CDA) technology, with active on-going class III CDA medical device product registration work in China and CDA test validation as a laboratory developed test (LDT) in the US.

AnPac Bio’s CEO, Dr. Chris Yu, commented, “Successful verification and commercialization of COVID-19 antibody testing in our San Jose lab is a major milestone. It signifies that AnPac Bio has entered into its commercialization and revenue generation phase in the US. Further, with the addition of our larger scale Philadelphia lab (once it is verified in the lab) planned for both COVID-19 antibody and cancer detection CDA tests (once it is approved for LDT), we will further accelerate our commercialization and revenue growth in the US.”

About AnPac Bio

AnPac Bio is a biotechnology company focused on early cancer screening and detection, with 128 issued patents as of June 30, 2020. With two certified clinical laboratories in China and one CLIA and CAP accredited clinical laboratory and one CLIA registered 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 and first in China 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 41,700 clinical samples as at May 2020. 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 Relations
Phone: +1-267-810-6776 (US)
Email: phil_case@AnPacbio.com

Investor Relations:
Ascent Investor Relations LLC
Tina Xiao, President
Phone: +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.

FAQ

What recent milestone did AnPac Bio achieve regarding COVID-19 testing?

AnPac Bio completed the FDA EUA verification for its COVID-19 antibody test in November 2020.

What is the significance of the testing equipment installed in Philadelphia?

The equipment is set to support COVID-19 antibody tests, furthering AnPac Bio's testing capabilities.

What does AnPac Bio focus on in addition to COVID-19 testing?

The company is also prioritizing cancer screening tests, particularly its Cancer Differentiation Analysis technology.

How does AnPac Bio plan to generate revenue following the recent milestones?

The commercialization of COVID-19 antibody tests is expected to initiate revenue generation for the company.

What markets is AnPac Bio targeting for its COVID-19 tests?

AnPac Bio is focused on the U.S. and China for its COVID-19 testing products and services.