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AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) 10 Years in the Making: Innovation Leads to Multi (Pan)-Cancer Screening

After ten years, the concept of (multi)pan-cancer screening pioneered by AnPac Bio-Medical Science Co., Ltd. (AnPac Bio) has finally been accepted and the industry is shifting toward early screening technology that detects multiple cancers in blood at one time.

In 2010, AnPac Bio proposed the theory of multi-cancer screening. At the time, the industry was divided over this innovative approach. The Company, however, persevered with the multi-cancer detection concept in an effort which included multiple patent applications and the launch of full technology and product development to help drive a generational shift in the face of a scientific community that was not always open to change.

Since 2015, AnPac Bio has commercially proven out its concepts through the development and sale of its cancer detection technology, cancer differentiation analysis (CDA) for early detection of pre-cancerous disease and cancer. The company has published numerous reports of clinical study results at major conferences, including ACSO conferences, and has been awarded over 100 patents globally. Anpac Bio is now able to make the claim that it is saving lives on a daily basis by detecting 26 different types of cancer very early, through the tens of thousands of commercial tests that are being performed annually.

Today, the multi-cancer industry continues to mature, and multi-cancer liquid biopsies are becoming recognized as the future of early cancer screening. Currently, the first line of screening for breast cancer is a mammogram, which is expensive When screening for colon cancer, a colonoscopy examination includes sedating the patient. These technologies have served its purpose in cancer diagnosis and treatment; however, the next generation technologies are based on testing blood and other bodily fluids for initial patient screening. A simple blood-based test and earlier detection of cancer will significantly reduce the disease burden and ultimately save the healthcare system and society a great deal of time and money.

AnPac Bio was one of the earliest next generation technologies and has demonstrated, through its research studies and positive data, the effectiveness of early cancer screening through its CDA technology and CDA platform, in which a simple blood-test can eliminate the need to screen patients using a mammogram or a colonoscopy for general population screening. While those forms of screening technologies are still necessary, they are increasingly being replaced by liquid biopsy tests when screening the general population.

AnPac Bio co-founder and CEO Dr. Chris Yu proposed the innovative methodology and cancer screening concept of “Multi-Cancer” more than a decade ago, as well as “Multi-Level, Multi-Parameter Screening”. Through continued research and innovation, AnPac Bio’s innovative team developed a proprietary technology, CDA, which is based on measuring biophysical properties and low-level signals to distinguish cancer patients from healthy individuals and to determine cancer risk.

At the heart of the CDA technology lies the core sensors that are able to accurately measure and amplify the low-level signals which allow highly sensitive measurements and earlier detection of abnormalities and potential cancers in blood (US Patent No. US 9,408,565). In addition to clinical studies, Anpac Bio has been commercially testing samples since 2015, which has allowed the company to build a large database of over 220,000 samples, consisting of both samples from clinical patients with clinical history and general population (for cancer risk determinations). As early as 2015, the Company presented some of its research at the annual ASCO conference, as well as several papers at the San Antonio Breast Symposium. All of the data and findings were based on the Company’s multi-level, multi-parameter, and multi-cancer screening CDA technology for early detection of cancer.

In recent years, the industry has begun to shift interest and is now moving towards multi-cancer screening and detection. Following the major announcement by AnPac Bio on its cancer detection technology’s capability to detect 16 types of cancer in 2014, and multiple papers by AnPac Bio at the 2015 ASCO conference, the National Cancer Center (NCC) of Japan announced the development of a method to screen for 13 cancers at simultaneously in 2017. In 2018, an article was published in Science by researchers at Johns Hopkins, which later became part of Thrive Earlier Detection Corp, around multi-cancer screening. In 2019, Grail, another liquid biopsy company, presented its data on their own pan-cancer blood early detection product and announced in 2020 that its pan-cancer product can screen for 50 cancers at once.  History has clearly and convincingly shown that AnPac Bio has been the inventor and leader in multi-cancer screening and has made critical contributions to this field.

AnPac Bio’s cancer detection CDA technology is a fully automated walk away solution, requiring a single tube of blood that is directly loaded on to the novel and proprietary CDA device, which measures the biophysical parameters in the blood through highly sensitive bio-sensors. CDA medical device is high-throughput and allows up to 40 samples to be loaded on to the platform deck. Each sample only requires 7 minutes to measure the signals. The multi-parametric raw data is processed through a proprietary machine-learning AI-based algorithm to generate a final CDA cancer risk score.  The Company is vertically integrated and fully autonomous. This includes AnPac Bio’s CDA machine as well as commercial testing through laboratories in the United States and China. CDA technology can be combined with other tests, such as protein based biomarkers, to provide more comprehensive information and data, which is called CDA platform.

The current ct-DNA (circulating tumor DNA) methods rely heavily on next-generation deep sequencing technology to detect low levels of DNA shed from the tumors. However, in precancerous and early stages of tumor development, the tumors are quite small and have limited to no shedding of tumor DNA. In addition, the half-life of any circulating DNA is quite short, and the analysis is further complicated by the presence of circulating DNA in blood seen in all individuals, both healthy and diseased.  This makes it highly challenging to develop a robust method that can detect ct-DNA accurately, particularly in early stages of cancer, and hence the poor performance of these tests for early cancer detection. AnPac Bio’s technology and approach is unique and does not depend on ct-DNA measurements using next-generation sequencing (NGS), and instead measures multiple-biophysical parameters and low level signals in the blood for precancerous and early stage detection of 26 different types of cancers, with high sensitivity and specificity, through an inexpensive and simple blood test.

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