The diagnostics industry is highly diverse, with a vast number of testing methods already on the market and a consistent flow of new technologies. In fact, diagnostics are no longer just about the detection of diseases, and now play a major role in the entire healthcare process - from screening, diagnosis and prognosis to patient stratification and treatment monitoring. Now, the role of artificial intelligence (AI) in diagnostics is also expected to change the market. AI platforms are expected to boost the growth of clinical diagnosis by scaling up healthcare services globally, leading to better patient safety, outcome analysis, and data collection. For example, a report by Grand View Research, Inc. indicates that IBM's Watson competes with human intelligence and has been proven to have enormous potential in the healthcare industry. AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Quest Diagnostics Incorporated (NYSE: DGX), GenMark Diagnostics, Inc. (NASDAQ: GNMK), Chembio Diagnostics, Inc. (NASDAQ: CEMI), Natera, Inc. (NASDAQ: NTRA)
Early diagnosis can increase the chances of a positive outcome, helping to improve the lives of patients and save costs of further treatment. According to a report by Asian Hospital & Healthcare Management, "Diagnostics can enable the shift from reactive, episodic treatment to predictive and integrated care. Earlier, personalised interventions can reduce health problems; help avoid adverse outcomes; decrease time spent in hospital; and help to avoid the cost of late-stage or unnecessary treatment... Increasing the use of appropriate diagnostic testing provides one of the greatest cost-savings opportunities around the world. In the US, for example, it has been estimated that earlier detection of certain cancers could save around USD 26 Billion per year. Closer home, a study in South Korea found that the early detection and treatment of common cancers can result in considerable savings in treatment costs. Advanced stage at diagnosis was associated with a 1.8-2.5 fold increase in total cost."
AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) announced earlier this week 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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Quest Diagnostics Incorporated (NYSE: DGX) announced earlier this week a new innovation in advanced genetic sequencing automation which will now enable individuals to access highly accurate genetic testing providing insights into inherited diseases including cancers of the breast, colon and other conditions through AncestryHealth(R). Quest developed a faster and cheaper way to perform next generation sequencing (NGS) to power AncestryHealth, a new consumer genetics offering launched by Ancestry(R) on August 3. AncestryHealth provides genetic screening of risks for an expanded set of health conditions -- such as heart disease, breast cancer, colon cancer and blood disorders. AncestryHealth powered by NGS looks at more regions in a person's genome than microarray-based testing technology.
GenMark Diagnostics, Inc. (NASDAQ: GNMK) a provider of automated, multiplex molecular diagnostic testing systems, announced back in June that its ePlex(R) Respiratory Pathogen 2 (RP2) Panel is now available for U.S. commercial distribution and clinical use. The ePlex RP2 Panel is one of the first rapid-result multiplex panel tests that can identify 21 pathogens, including SARS-CoV-2, to be made available for clinical use. The company also submitted an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration for the ePlex(R) Respiratory Pathogen 2 (RP2) Panel earlier this month. "The ePlex RP2 Panel is designed to enable clinicians to quickly determine the cause of infection and the best course of treatment. This is especially vital for individuals who are vulnerable, such as the elderly, people with compromised immune systems, and children, and therefore at increased risk for the new coronavirus and other common and often serious respiratory illnesses," said Scott Mendel, President and CEO of GenMark. "One recent study highlighted that about 20% of COVID-19 patients are also infected with other respiratory pathogens.2 Syndromic panels that provide broad coverage of viruses and bacteria from one patient sample will be critical this flu season, which is expected to coincide with continued SARS-CoV-2 infections."
Chembio Diagnostics, Inc. (NASDAQ: CEMI) is a point-of-care diagnostics company focused on detecting and diagnosing infectious diseases. The Company reported back in April that it has received Emergency Use Authorization (EUA) for its DPP COVID-19 System. The DPP COVID-19 System is a serological test and analyzer that provides numerical readings for both IgM and IgG levels within 15 minutes from a simple finger stick drop of blood. Both Chembio's Micro Reader 1 and Micro Reader 2 analyzers are compatible with the test. "We are very pleased with the continued progress our teams are making to address the market demands with our DPP COVID-19 serological system," stated Rick Eberly, Chembio's Chief Executive Officer. "The flexibility of having two analyzers and a system that provides high sensitivity and specificity that is generally consistent with the performance of Chembio's other DPP platform tests as part of our offering places us in a unique position to serve a variety of markets. Additionally, we are pleased to announce that our manufacturing team has produced and shipped our first lots of the COVID-19 Systems, and we look forward to providing further product within the US and abroad."
Natera, Inc. (NASDAQ: NTRA) announced earlier last 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(TM), 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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