Market Overview

Scientists Strive to Diagnose Illnesses Before Symptoms Appear

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NEW YORK, July 29, 2020 /PRNewswire/ -- The diagnostics industry is a large and diverse entity, with new innovative technology constantly under development. Diagnostic tests are usually conducted in laboratories, private or public, which are equipped with appropriate and sometimes expensive instrumentation and staffed with trained and qualified personnel to perform the tests. There are also various types of diagnostic methods including In Vitro Diagnostics (IVD), Point Of Care (POC), Molecular diagnostics, genomic diagnostics and others. A major factor contributing to the growth of this industry is the penetration of technologically advanced laboratory systems that have improved oncological screening in yielding accurate outcomes. In addition, cancer research organizations, along with public and private entities, are investing heavily in research projects to launch new, advanced diagnostic tools, which are capable of diagnoses significantly before the symptoms appear. Overall, according to Grand View Research, Inc., the global cancer diagnostics market size was valued at USD 144. 4 Billion in 2018 and is expected to reach USD 249.6 Billion by 2026 while registering a CAGR of 7.0% over the forecast period. AnPac Bio-Medical Science Co., Ltd. (NASDAQ:ANPC), Exact Sciences Corporation (NASDAQ:EXAS), Veracyte, Inc. (NASDAQ:VCYT), Guardant Health, Inc. (NASDAQ:GH), Natera, Inc. (NASDAQ:NTRA)

The World Health Organization (WHO) has published data about the global epidemiology of cancer. Overall, cancer is one of the most common diseases, with as many as 14 million new cases each year and accounts for over 8.8 million deaths around the globe. These notable figures are further aggravated by future projection of incidence and prevalence, wherein the total number of new cancer cases is predicted to increase by over 70% over the next 2 decades, paralleled by a similarly increasing number of deaths. Early diagnosis is key. According to a research by Section of Clinical Biochemistry, University of Verona, "Irrespective of the unquestionable role of prevention in limiting the dramatic epidemiological burden of cancer, screening and early diagnosis are the cornerstones for establishing a timely therapeutic management, which may contribute to save many lives worldwide."

AnPac Bio-Medical Science Co., Ltd. (NASDAQ:ANPC) just announced breaking news this morning that, "it had completed over 180,000 Cancer Differentiation Analysis ("CDA") based tests as of July 15, 2020.

AnPac Bio had previously completed more than 169,000 CDA-based tests as of March 31, 2020. From April 1, 2020 to July 15, 2020, the Company completed over 10,000 commercial CDA-based tests and over 1,000 CDA-based tests for research purposes, which increased the cumulative number of CDA-based tests to over 180,000.

"We are honored to have achieved this milestone, which demonstrates the market-wide acceptance of our products. We offer a comprehensive product offering to meet different customers' needs and to address this large and growing market. Our CDA-based test can detect and assess an individual's overall risk of having or developing cancers, and a cancer risk assessment report is the final product of the test. The report presents the analytical parameters that our CDA test uses, including the PTF, CTF and overall CDA values," said Dr. Chris Yu, CEO and Chairman of AnPac Bio.

Dr. Chris Yu continued, "Our CDA-based test is advanced in many ways. Unlike conventional cancer screening and detection approaches such as imaging technology and tissue biopsy, our CDA test uses liquid-based technology to detect the risk of cancer and non-cancerous diseases. It is minimally invasive, side effect-free and highly automated. Because it focuses on changes in cancer-related biophysical properties as a disease progresses, we believe that our CDA test can be used for multiple purposes, including early cancer screening and detection, and assistance in cancer diagnosis, prognosis and recurrence."

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 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. In a 2019 market research report by 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."

Exact Sciences Corporation (NASDAQ:EXAS) announced last month the publication of results highlighting the performance of the Oncotype DX Genomic Prostate Score® (GPS™) result in patients with unfavorable intermediate (UFI)-risk prostate cancer. Published in Urology, the new results demonstrate the GPS test is a strong independent predictor of critical outcomes in UFI-risk prostate cancer patients. "While men with very low-, low- and favorable intermediate-risk prostate cancer often choose between active surveillance and treatment, men with unfavorable intermediate-risk disease must make decisions about how aggressive their treatment plan should be," said Jennifer Cullen, Ph.D., M.P.H., lead author of the publication and Associate Director of Cancer Population Sciences at the Case Comprehensive Cancer Center in Cleveland. "These new findings, which demonstrate for the first time the GPS test as a strong predictor of critical endpoints in UFI-risk disease, indicate that Oncotype DX® testing can aid physicians and UFI-risk prostate cancer patients in their decision-making process. The GPS score may help in decisions regarding treatment intensity and empower patients in their care choices."

Veracyte, Inc. (NASDAQ:VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company's tests in thyroid cancer, lung cancer, breast cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping test is in development. Last month, the Company announced its submission of a De Novo classification request to the U.S. Food & Drug Administration (FDA) for the nCounter® Dx LymphMark™ Assay, a novel, genomic lymphoma subtyping test. The in vitro diagnostic test is used on the nCounter Flex Analysis System, Veracyte's diagnostics platform, and is intended to add to Veracyte's portfolio of tests that address complex clinical problems, helping to inform diagnoses and better treatment decisions. "DLBCL is an aggressive form of lymphoma with heterogeneous clinical behavior – outcomes significantly depend upon the distinct molecular subtype of each patient's tumor," said Dr. David Scott, associate professor in the Department of Medicine at the University of British Columbia and a scientist in the Department of Lymphoid Cancer Research at BC Cancer, a program of the Provincial Health Services Authority.

Guardant Health, Inc. (NASDAQ:GH) reported last month new data at the American Association for Cancer Research (AACR) Virtual Annual Meeting II demonstrating that its LUNAR-2 liquid biopsy is a highly sensitive test that can detect early-stage colorectal cancer (CRC). "Colorectal cancer remains a leading cause of cancer-related death, yet it is estimated that nearly 1 in 3 American adults are not up to date with screening recommendations despite the availability of colonoscopies and stool-based testing. Our LUNAR-2 assay holds the promise to directly improve cancer screening rates by addressing patient non-compliance with a simple blood test. This study confirms that our test can consistently detect early-stage colorectal cancer," said Dr. Kathryn Lang, Guardant Health Vice President of Outcomes and Evidence.

Natera, Inc. (NASDAQ:NTRA) announced earlier this month two distinct studies (one oral and one poster presentation) at the recent 2020 virtual ESMO World Congress on Gastrointestinal Cancer that took place July 1-4, 2020. The studies highlight: a) the clinical validity of Signatera™, a personalized and tumor-informed circulating tumor DNA (ctDNA) assay for identifying molecular residual disease (MRD) in patients with oligometastatic CRC; and b) a prospective trial, already in progress, that will measure the clinical outcomes of MRD-guided treatment in stage II-III CRC patients. "Now that Signatera is being used in prospective interventional trials, we're seeing confirmation that it can help inform treatment decisions after oligometastatic resection in the 20 percent to 30 percent of patients with metastatic CRC,"1-3 said Alexey Aleshin, M.D., M.B.A., Natera's Senior Medical Director for Oncology. "This clinical data suggest ctDNA testing is a highly accurate tool in guiding treatment and supports the advancement of our efforts with Signatera to improve cancer management."

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