Summary
After ten years of hard work, the pan-cancer screening concept and efforts led by AnPac Bio-Science Co., Ltd. (“AnPac Bio”; NASDAQ: ANPC) since 2010 is gaining market acceptance and traction. AnPac Bio’s cancer screening technology uses sensors fabricated by integrated circuit (IC) process to detect multiple cancers in the blood at the same time. According to US marketing research firm Frost-Sullivan, AnPac Bio ranked top three globally in terms of clinical and commercial test sample numbers in the space of new cancer detection technologies in 2019. In the next five years, AnPac Bio strives to become a global leader in early cancer screening, continuing to make meaningful contributions to the global cancer prevention cause.
Lead:
As early as 2010, AnPac Bio proposed a pan- (multiple) cancer screening theory and method to change the way science and medical professional perform cancer tests. The hope was to help cancer testing become cheaper, faster, earlier, and cover more cancer types in one test. Some of Anpac’s issued patents in the US and China dated original ideas as early as 2010s1-3, and clinical study data were collected and available as well in that same period. By 2014, it had already publicly announced its cancer detection product capable of detecting 16 types of cancer, which was much earlier than other company in the market.
The medical industry was perhaps not ready, and many doubted if pan cancer screening could even be a possibly. Some called AnPac Bio’s pan cancer idea and clinical data “too good to be true”. Cancer experts had different opinions on this concept. Some of them believed that cancer should be screened one by one, because some reasoned, after all, each cancer type is different. Some experts further believed that some cancer types are not even suited for blood tests such as brain tumors and esophageal cancer. Contrary to accepted opinions, AnPac Bio believed in its groundbreaking idea and innovation, forged ahead and persisted in proving out its Cancer Differentiation Analysis platform.
Dr. Chris Yu, Chairman and CEO of ANPC stated, “In the past ten years, AnPac Bio has spared no effort in pioneering this concept, even though we were doubted and laughed at by some people in the field. Our hard work to validate and promote the approach includes numerous retrospective clinical trials with many hospitals (no fewer than two), prospective and follow-up studies, significant applied and published patent applications involving pan-cancer screening claims in multiple countries, various publications at technical conferences including ASCO in the US4-7, and news releases. At the same time, with the active promotion and progress of peer companies in the field, and extensive data validating this concept first by AnPac Bio (Anpac Bio published at 2015 ASCO) and later by other companies, the innovative theory of pan-cancer screening was finally accepted by most of the industry over the last few years. Although groundbreaking innovation is often lonely and hard, we must always believe in ourselves and perseverance.”
Dr. Chris Yu’s highly successful career included significant research work at three US Fortune 500 company and other publicly listed high tech companies, through cross-disciplinary and break through innovations. He has significantly changed the IP and technology landscape and made profound impact on the long term roadmap in at least two areas in which he has worked. He has been a co-founder or founding executive member of three publicly listed high tech companies (including two companies on the NASDAQ and one company on the Science and Technology Innovation Board of the Shanghai Stock Exchange). He is an inventor of over 300 patent applications in about 20 countries and regions around the world, of which nearly 200 have been granted. He has repeatedly developed cross-disciplinary innovation ideas and successfully commercialized winning products based on those ideas, with a global revenue exceeding USD $4 billion.
Dr. Yu was born in a medical family and studied at Shanghai Second Medical College (now Shanghai Jiao Tong University School of Medicine). However, he was diagnosed with partial color blindness and had to switch his major to physics. After receiving a PhD degree in physics (with a PhD thesis on a novel detection technology for weak signal detection and processing) from Pennsylvania State University, he worked at leading US semiconductor companies including Micron Technology and Motorola. After returning to his hometown Shanghai, China, beginning in 2008, Dr. Yu began contemplating how physics, IC technologies, and his knowledge about signal detection and processing can be used for cancer detection. Dr. Yu believed that the measurement of biophysical properties could be combined with his extensive work experience in the semiconductor industry to design and fabricate novel and highly sensitive sensors. Therefore, the use of an innovative IC device with unique sensors for the detection of biophysical characteristics in blood in order to detect cancer earlier became the original development concept of AnPac Bio.
He and his co-inventor filed their first patent application in 2009, and co-founded AnPac Bio in 2010, looking to develop a cost-effective pan cancer detection technology. Dr. Yu began to devote himself to the application of fusing the latest in semiconductor design and fabrication with the measurement of biophysical properties to detect cancer. Together with co-founder Professor Herbert Yu and R&D vice president Du Xuedong, he founded AnPac Bio to become one of the first companies to develop cancer screening by detecting biophysical properties.
In January 2020, AnPac Bio was listed on the US NASDAQ stock market. Based on 2020 full year and 2021 Q1 financial reports, AnPac Bio is now one of the fastest growing publicly traded companies in the field.
AnPac’s technology is around its proprietary “Cancer Differentiation Analysis”, or CDA test, which is based on the correlation between biophysical characteristics in the blood sample and cancer risk. This technology and emerging technologies such as CTC, ct-DNA and exosomes are called “next generation” cancer screening and detection technologies.
At the beginning of 2010s, AnPac Bio applied for pan-cancer detection patents and developed an important, novel sensor for detection. The company conducted clinical research with many medical institutions to collect a large number of clinical study samples (> 40,000 clinical samples).
In 2014, AnPac Bio announced that its technology is capable of detecting 16 types of cancer. By 2015, the Company had published four papers at 2015 ASCO4-7, which included clinical study data on lung cancer, liver cancer, esophageal cancer, and colorectal cancer.
Other companies in the cancer screening space, including Grail8, and Thrive9, which is based on CancerSEEK technology originating at Johns Hopkins University, have also begun to establish pan-cancer tests.
The complete process of AnPac’s cancer detection technology involves using internally developed and fully automated equipment to detect the biophysical parameters in the blood, and then calculate data based on proprietary algorithms to assess the level of cancer risk.
The purpose of early cancer screening is for early detection, early diagnosis, and early treatment. Very often, at early cancer stage, there are no obvious symptoms, and the significance of early screening is to conduct a risk assessment when the subject has no obvious symptoms. Those who are assessed as having a high risk of cancer is advised to go to a medical institution for further examination, so that they can discover potential cancer earlier.
AnPac Bio detects the biophysical parameters in the blood. This technology has the advantages of detecting multiple cancer types at early stage, with a high sensitivity and specificity, and at a lower cost.
Presently, AnPac Bio’s CDA platform can test up to 24 types of cancer in men and 26 types of cancer in women at one time, and the types of cancers detected are increasing. In addition to screening cancer patients, based on the follow-up data of more than 14,000 subjects, AnPac Bio’s detection technology has also detected a large number of patients with precancerous lesions. “This shows that our technology can also identify pre-cancer diseases and risk.” Dr. Yu stated.
“Before, there are many cancer types that cannot be easily detected and screened, and they have no known- bio-markers, however, our CDA technology can be used for preliminary screening. We fill the technological gap in this area. For example, with esophageal cancer and brain tumor, there are currently no established bio-markers available. The traditional method of esophageal cancer detection is endoscopy, but AnPac Bio’s technology can use blood to screen for esophageal cancer.” Dr. Yu continued.
Since its founding, AnPac Bio has firmly established the direction of independent research and development for the application of biophysics in high-throughput pan-cancer screening. The use of proprietary equipment has resulted in huge advantages in operating costs and company growth. In 2020, under a global health pandemic, cancer screening industry was greatly affected. However, revenue of AnPac Bio increased by 89% year-over-year, and its loss decreased by 20% year-over-year, which put AnPac Bio at one of the best performing companies (in terms of revenue growth and net loss decrease) in the field. This significant advantage is expected to continue.
The higher rate of revenue growth over its publicly traded peers by AnPac Bio indicates that its technology and products are gaining increased market acceptance and market share.
Early cancer screening is an area that requires long-term investment. At present, the early cancer screening industry still faces many challenges. In addition to the need to continuously improve detection sensitivity and specificity, the difficulties include reducing detection costs and enhance market acceptance. AnPac Bio is well prepared to meet the above stated challenges, with its low cost structure, pan cancer screening strategy, and improving cancer detection sensitivity and specificity with further optimized algorithm (with increased larger data set) and new generation of sensors.
AnPac Bio recently announced completion of research and development, and validation of a new generation of sensors. “The design and process flow of the chip has been further optimized, which resulted in sensor device yield increase, and significant improvement in detection signal stability.” Dr. Yu said.
Normally, if a subject is assessed to be at high risk after an early cancer screening through a CDA test, the next step may be further testing and diagnosis in the hospital, and then cancer treatment. Cancer treatment is of course a crucial area in the medical field. For AnPac Bio, it may also be an extension of the company’s core technology which includes its expertise in biophysics and IC design and fabrication, as well as its deep understanding on what and how biophysical properties may have played a role in cancer evolution, and how biophysical signals change as the disease evolution is taking place.
“We have collected a significant amount of clinical data and found that as the condition of the potential cancer patients develops, biophysical indicators also change in a statistically significant way. We believe that the changes in biophysical indicators are related to the progression of the disease,” said Dr. Yu.
“Research by other groups have also found that changes in the micro-environment may lead to increased genetic mutations and cell division errors, which may further lead to diseases, including cancer. We are trying to explore whether we can use biophysical intervention and treatment methods to control diseases and prevent it from progression, or even directly reverse the process. Physical or Biophysical treatment technologies have already been successfully applied in certain cancer therapeutic fields, and AnPac Bio is also confident in attempting to develop our own novel technology in this area.”
The Company has continued to make progress towards its goals in 2021. On January 25, China’s National Medical Products Administration (NMPA) approved AnPac Bio to start the registration and testing of its Class III lung cancer auxiliary diagnostic medical devices in its designated medical device testing laboratory.
In late May, AnPac Bio announced that it would develop innovative cancer treatment technologies based on a biophysical approach. It is expected that the new technology will use key therapeutic modules manufactured by IC technology to intervene and treat cancer patients who exhibit abnormal biophysical characteristics. This project is expected to begin laboratory tests in the third quarter of 2021.
AnPac Bio continues to make tangible contributions to the cause of cancer prevention via its efforts in groundbreaking novel ideas, and develop them into cost effective products and services to benefit society as a whole. “We hope that in the future, AnPac Bio will become a role model of science and technology, as well as innovation.” Dr Yu stated.
References
(1) US Patent# 9,408,565.
(2) US Patent# 9,689,863.
(3) Chinese Patent# CN 103608682 B.
(4) Y. Zhang, et al., Abstract# e12578, J Clin Oncol 33, 2015.
(5) J. Ji, et al., Abstract# e22171, J Clin Oncol 33, 2015.
(6) X. Du, et al., Abstract# e12587, J Clin Oncol 33, 2015.
(7) G. X. Jiang, et al., Abstract# e15059, J Clin Oncol 33, 2015.
(8) GRAIL Press Release https://grail.com/press-releases/grail-announces-positive-new-data-with-multi-cancer-early-detection-blood-test-from-ccga-study/
(9) J.D. Cohen, et al., Science 10.1126/science.aar3247(2018)
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