Researchers Look for New Ways to Boost Diagnostic Capabilities

NEW YORK, Oct. 2, 2020 /PRNewswire/ -- The global cancer diagnostics market is of the more innovative segments of the global diagnostics industry today. Cancer is one of the leading causes of death across the world, and its prevalence has been growing at an alarmingly fast rate. Early detection is a key factor to successfully combat cancer. Although various screening procedures, such as lab tests, imaging, and endoscopy, enable disease detection at an early stage, there are certain risk factors posed by medical imaging. As a result, medical professionals and innovators are focusing on development of effective diagnostic and treatment solutions in order to increase early detection rates. And, overall, the global cancer diagnostics market size is expected to reach USD 249.6 Billion by 2026, according to a new report by Grand View Research, Inc., while exhibiting a CAGR of 7.0% during the forecast period. AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Exact Sciences Corporation (NASDAQ: EXAS), Bluebird bio, Inc. (NASDAQ: BLUE), GlaxoSmithKline plc (NYSE: GSK), Exelixis, Inc. (NASDAQ: EXEL)

The cancer diagnostics market is highly competitive, including a large number of big and small players operating in various market segments. Technological advancements in various fields such as biomarkers, imaging, biopsy, and endoscopy have generally benefited the market greatly over the years. For example, earlier in September, the Association for the Advancement of Artificial Intelligence (AAAI) awarded a MIT professor USD 1 Million for work in cancer diagnosis and drug synthesis. "The recipient, Regina Barzilay, the Delta Electronics Professor of Electrical Engineering and Computer Science at MIT and a member of MIT's Computer Science and Artificial Intelligence Laboratory (CSAIL), is being recognized for her work developing machine learning models to develop antibiotics and other drugs, and to detect and diagnose breast cancer at early stages," according to MIT News.

AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) announced breaking news yesterday that, "the Company has entered into an agreement with Keystone Capital Partners ("Keystone") for a preferred stock investment of US$7.0 Million. Additional details on the transaction are outlined in the accompanying Registration Statement filed on September 30, 2020 (File No. 333–249170).

The investment provides AnPac Bio with additional access to growth capital to expand its operations in China and continue to commercialize in the United States. Additionally, the Company intends to use the funding proceeds to advance its CDA (Cancer Differentiation Analysis) technology to provide cost-effective early-detection cancer screening and testing.

The information contained in this press release shall not constitute an offer to sell or the solicitation of an offer to buy the shares of our preferred stock discussed herein, nor shall there be any offer, solicitation, or sale of the shares in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. A registration statement relating to these securities has been filed with the U.S. Securities Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.

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 Corporation (NASDAQ: EXAS) reported back in June 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."

Bluebird bio, Inc. (NASDAQ: BLUE) and Bristol Myers Squibb announced on July 29th, the submission of their Biologics License Application to the U.S. Food and Drug Administration for idecabtagene vicleucel (ide-cel; bb2121), the companies' investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma. This submission provides further details on the Chemistry, Manufacturing and Controls module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020.  The submission is based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of ide-cel in relapsed and refractory multiple myeloma patients exposed to an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Results from the study were shared during an oral presentation as part of the American Society of Clinical Oncology 2020 Virtual Scientific Program.

GlaxoSmithKline plc (NYSE: GSK) announced on July 24th, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of belantamab mafodotin as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.  Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "Today's positive opinion from the CHMP is an important step in helping patients suffering from relapsed or refractory multiple myeloma who currently have limited options and poor outcomes. If approved, belantamab mafodotin will provide patients and physicians across much of Europe with a first-in-class anti-BCMA treatment option that works differently from other available therapies for this incurable disease."

Exelixis, Inc. (NASDAQ: EXEL) announced on July 20th, the initiation of CONTACT-03, a global phase 3 pivotal trial of cabozantinib in combination with atezolizumab in patients with inoperable, locally advanced or metastatic renal cell carcinoma who progressed during or following treatment with an immune checkpoint inhibitor as the immediate preceding therapy. CONTACT-03 is part of a clinical trial collaboration between Exelixis and Roche that includes two additional phase 3 pivotal trials – CONTACT-01 in patients with metastatic non-small cell lung cancer who have been previously treated with an immune checkpoint inhibitor and platinum-containing chemotherapy and CONTACT-02 in patients with metastatic castration-resistant prostate cancer who have been previously treated with one novel hormonal therapy – both initiated in June 2020. "The treatment landscape for metastatic kidney cancer is rapidly evolving as the use of immune checkpoint inhibitor-based regimens move to earlier lines of therapy," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "More data are needed to better understand the sequential use of treatments for this patient community, and we look forward to learning more about the potential role of the combination of cabozantinib and atezolizumab following checkpoint inhibitor therapy in this pivotal trial with our partner Roche."

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