Doctors Reap the Benefits of Improving Diagnostic Capabilities

NEW YORK, Aug. 4, 2020 /PRNewswire/ -- The diagnostics industry is large and diverse, with new innovative solutions constantly changing its landscape. Generally, diagnostic tests are conducted in laboratories, private or public, which are equipped with appropriate and often expensive equipment and medical devices which require highly qualified personnel to perform the tests. Among the many drivers contributing to the growth of the industry is the prevalence of infectious diseases, various types of cancers, increasing awareness and acceptance of personalized medicine and companion diagnostics, growth in the biomarker identification market, and advancements in molecular techniques. Since cancer is one of the most common diseases, with as many as 14 million new cases each year according to data by the World Health Organization (WHO), cancer research organizations are investing heavily in research projects to launch new diagnostic tools, which are more likely of to give accurate diagnoses before the symptoms appear. And, according to MarketsandMarkets Research, the global molecular diagnostics market size is projected to reach USD 11.54 Billion by 2023 from USD 7.71 Billion in 2018 while expanding at a CAGR of 8.4%. AnPac Bio-Medical Science Co., Ltd. ANPC, Exact Sciences Corp. EXAS, Abbott Laboratories ABT, Biogen Inc. BIIB, Johnson & Johnson JNJ.

While the diagnostic industry growth is due to demand for faster and more accurate testing and procedures, the biotech industry, which is driven by the similar concerns like viral infections and cancer, is investing in innovative therapies. Matt Kapusta, CEO of uniQure, explained according to Labiotech that, "Biotech is typically first in highly innovative fields. Typically, pharma is more earnings-conscious and thinks that if a biotech can prove an innovative technology works, then the company will collaborate or acquire its way in."

AnPac Bio-Medical Science Co., Ltd. ANPC just announced breaking news that, "preliminary results from two prospective studies demonstrated that AnPac Bio's Cancer Differentiation Analysis (CDA) based tests have the ability to assess the risks of cancer occurrence.

In a study of follow-up phone consultations commenced in 2017, over 13,000 individuals (including individuals tested with high risk, medium risk and low risk CDA scores) had provided the company with substantive feedback regarding their health conditions and disease development as of July 31, 2020, and among them, there had been diagnosed over 190 cancer cases, over 900 pre-cancer cases, and 700 disease cases, with higher predictive values being statistically significantly higher from individuals with higher CDA scores. In another prospective study that began last year with close to 2,000 individuals of 65 years old or above, 10 cancer cases have been confirmed. The above results demonstrated that CDA technology is capable of assessing pre-cancer and early stage cancer risks.

AnPac Bio's CEO, Dr. Chris Yu, commented, "While there are a number of cancer screening technologies aimed at detecting cancer early, only a limited number of them have proven the ability to do so, with many of them still in the R&D phase. AnPac Bio's CDA technology has been demonstrated, in both retrospective and prospective studies, to be able to detect pre-cancer disease and early stage cancer signals with statistical significance. We are proud to be saving lives."

Dr. Chris Yu continued, "Cancer screening markets in both US and China are significant and growing. The current global cancer diagnostics market size is $144 Billion and expected to grow up to $249 Billion by 2026. We believe that AnPac Bio is well positioned to capture these markets with our innovative technology, significant patent portfolio, one of the world's largest clinical sample size among companies offering next-generation early cancer screening and detection technologies, and extensive experience in cancer screening and detection."

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. 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."

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Exact Sciences Corp. EXAS announced on May 5th, new research that uses real-world-adjusted adherence rates in a colorectal cancer microsimulation, the Colorectal Cancer and Adenoma Incidence and Mortality model (CRC-AIM), to reinforce the value of Cologuard (mt-sDNA) as an effective colorectal cancer screening test. Cologuard offers significant advantages over the fecal immunochemical test (FIT) and real-world adherence data further highlights those advantages. Cologuard has higher sensitivity, a longer interval, and higher observed adherence rates in real-world usage. The modeling also highlights the importance of improving access to colonoscopy following a positive Cologuard or FIT test. "Policymakers and other leaders often rely on modeling to make decisions about colorectal cancer screening," said Dr. Paul Limburg, Chief Medical Officer of Exact Sciences' screening business. "Modeling that incorporates real-life patient behaviors, and the impact of those behaviors on health outcomes, is limited. This new suite of abstracts provides insight into the effect that complex and dynamic patient patterns have on colorectal cancer screening outcomes."

Abbott Laboratories ABT announced last year that it has received CE Mark for the world's most sensitive rapid diagnostic test for the detection of hepatitis B surface antigen, the Determine™ HBsAg 2 test for use with serum, plasma or whole blood. This highly sensitive, easy-to-use, rapid lateral flow test enables identification of those with the virus and facilitates linkage to care in every healthcare setting. Hepatitis B is a serious liver infection caused by the hepatitis B virus (HBV). For some people, hepatitis B infection becomes chronic and can lead to liver failure, liver cancer or cirrhosis of the liver, a condition that permanently scars the liver. "To achieve the WHO targets, 107 million HBV-infected people need to be urgently diagnosed, especially in highly endemic regions in Africa and Asia," said Damian Halloran, vice president, Infectious Disease-Emerging Markets, Abbott. "The unparalleled sensitivity, portability and ease-of-use of the Determine HBsAg 2 provides life-changing technology that can dramatically scale up testing services so more infected people can know their status and get treatment earlier."

Biogen Inc. BIIB together MIT and Harvard, and Partners HealthCare announced in April a consortium that will build and share a COVID-19 biobank. The biobank will help scientists study a large collection of de-identified biological and medical data to advance knowledge and search for potential vaccines and treatments. Biogen will help employees who wish to volunteer connect with the project. The volunteers are among the first people in Massachusetts to be diagnosed with and recover from COVID-19, as well as close contacts of those individuals, including people who were not tested or who may not have had symptoms. According to researchers, this unique, clustered group of patients with a common exposure will offer a valuable lens into why some people show signs of disease and others are asymptomatic. It may also shed light on why among those with symptoms, some have more severe symptoms than others. Researchers will also examine blood samples from recovered patients to evaluate the levels of neutralizing antibodies against SARS-CoV-2 and other aspects of their immune profile, which may point the way toward short- and long-term therapeutic options.

Johnson & Johnson JNJ last week that that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. The data, published in Nature, show the Company's investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by "neutralizing antibodies," successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical study. Based on the strength of the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now commenced in the United States and Belgium.

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