In recent years, advances in technology have led to demand for early cancer testing and screening methods that are less invasive and lower cost. Insurance companies have accepted that traditional testing methods are labor intensive and are not ideal as the first line of defense when screening and diagnosing cancer. This has opened a multi-billion-dollar market opportunity in discovering new solutions to tackle cancer and disease testing outside of traditional diagnostics that have been used for generations without any major upgrades or breakthroughs. AnPac Bio-Medical Science Co., Ltd. (ANPC.US), a biotechnology company focused on early cancer screening and detection as well as cancer treatment, has established itself in China as a leader in disease screening and diagnosis, as well as having a team and bio-medical lab in the US, as the industry undergoes this transitional shift. It has championed a groundbreaking idea and technology called multi-(pan) cancer screening technology since 2010, and developed and announced multi-cancer screening technology in 2014, much earlier than most of is peers. It has developed a highly innovative cancer screening technology called Cancer Differentiation Analysis technology (CDA).
Taking advantage of this new paradigm, AnPac Bio finished with strong revenues in 2020, up 89.3% year-over-year, despite the global pandemic. Companies like New Horizon Health, listed in Hong Kong (6606.HK), achieved revenue growth of 20.0% in 2020 versus the prior fiscal year, and Genetron Health (NASDAQ: GTH), achieved revenue growth of 31.4% in 2020 versus the prior fiscal year. AnPac Bio’s growth also compares favorably with other companies in the space, including Burning Rock Biotech (NASDAQ: BNR) and Amoy Diagnostics (300685.CN) which exhibited year over year revenue growth in 2020 of 12.8% and 26.2% respectively.
AnPac Bio recently pre-announced rapid growth in testing volume in the first half of 2021, with total paid customer visits and total testing volume increasing by approximately 110% compared to the same period in 2020. In the second quarter of the year, AnPac Bio’s total paid tests and paid cancer tests increased by approximately 280% and approximately 270%, respectively, compared to the first quarter of the year. In addition to paid cancer tests, other tests, including new tests launched in 2020, also grew.
Positive Momentum Continues for AnPac Bio in 2021
On January 25, the State Drug Administration of China (NMPA) approved AnPac Bio to start the registration testing of Class III lung cancer adjuvant diagnostic medical devices in its designated medical device testing laboratory. This is one of the last steps in the registration process of a Class III medical device for this market. Upon achieving class III registration, AnPac Bio will be able to sell its devices into every hospital in the country.
In late February, AnPac Bio developed and completed testing of its next generation multi-cancer detection sensor, the CDA Pro sensor (CDAPS), which is a technological breakthrough for the Company, and included improvements in detection signal stability, sensor yield, cost, and overall sensitivity and specificity, when compared to the previous generation of cancer detection sensors. In particular, the sensitivity and specificity of cancer detection reached over 95% in a retrospective clinical sample test.
In late May, AnPac Bio also announced that it will develop an innovative cancer treatment technology based on biophysical principles. This new technology is expected to utilize key therapeutic modules manufactured with integrated circuit (IC) technology to treat cancer patients through intervening with biophysical properties that exhibit an abnormal range. This program is expected to begin laboratory validation in the third quarter of 2021.
On June 7, AnPac Bio was also granted its first patent for a disease treatment invention by the United States Patent and Trademark Office. The patent covers novel device structures and methods for modifying the properties of biological samples for the purpose of cancer treatment. It is the 21st patent granted to AnPac Bio in the United States. AnPac Bio also announced that it has received over $4 million in financing for its cancer therapy program, which will fund the manufacture of a medical device for cancer therapy and laboratory testing of the device.
AnPac Bio has also recently begun providing medical device development services and is marketing its services to multinational corporations and other large healthcare companies in China. It is believed that there is a market need for AnPac Bio’s highly differentiated multi-cancer testing approach to the cancer screening industry and its “multi-level, multi-parameter screening” technology, which analyzes the correlation between biophysical characteristics and cancer risk.
Over the past few years, scientists have taken a renewed interest in biophysical properties and the relationship between cancer association and cancer causation, with results confirming that changes in biophysical properties do lead to cancer and other pre-cancer diseases. While the biophysical approach is based on established science, technological advancements have made the measurement of these properties both more cost-effective, elegant, and with rapid results when simultaneously screening multiple cancers.
AnPac Bio’s CDA technology is a highly sensitive, multi-level detection device which measures biophysical indicators in the blood through a sensor made of integrated circuit technologies and collects weak signals at multiple levels and parameters of clinical significance. CDA measures the protein level, the cellular level, and some molecular levels, and ultimately makes a risk assessment of the presence and occurrence of cancer when a multiparameter computational model shows a high probability.
In studies performed in China, CDA technology has exhibited strong data in finding stage I cancers, and even stronger data when identifying precancerous groups. In later follow-ups, CDA technology also distinguished between some precancerous lesions and stage I cancer patients. CDA has a more fluid approach to cancer screening then other methods, as it is focused on subtle changes in the body and is not a static measurement that only takes into account one point of time.
CDA technology is the 21st century approach to using biophysical properties as the cornerstone to screen for cancer and precancerous diseases. AnPac Bio’s background and expertise in semiconductor fabrication and weak signal detection makes them ideally suited to be a leader in developing diagnostics that can screen for disease in a rapid format and at a low cost.
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