FinancialBuzz.com News Commentary
New York, NY (9/4/2020) – The diagnostics industry is a large and varied market, with new and innovative technology constantly being introduced. There are also various types of diagnostic methods including In Vitro Diagnostics (IVD), Point of Care (POC), Molecular diagnostics, genomic diagnostics and others. Overall, 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 diagnostic tools. The goal is to diagnose cancer as early as possible, to reduce mortality rates and increase treatment management effectiveness. 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. AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Exact Sciences Corp. (NASDAQ: EXAS), Guardant Health, Inc. (NASDAQ: GH), GlaxoSmithKline plc (NYSE: GSK), NeoGenomics, Inc. (NASDAQ: NEO)
The cancer diagnostics market is highly competitive, with 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 benefited the market greatly over the years. As such, the growing prevalence of cancer, the rapid rise in aging population, increasing number of awareness initiatives by governments, and growing government funding are all pushing this segment to new highs. 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) this morning the company announced, “positive results from a successfully completed a multi-year lung cancer prognosis and recurrence study in collaboration with a major hospital in China. The clinical study began in 2014, with the enrollment and completed all follow-up and testing in 2020. Approximately 1,000 confirmed lung cancer patients were tested in the clinical study using AnPac Bio’s cancer differentiation analysis (CDA) technology for prognosis and recurrence utility evaluations throughout initial diagnosis, surgery, chemotherapy and other treatments, and remission (for recurrence monitoring).
Initial results from the study indicate that CDA technology could act as a viable tool for measuring and evaluating (1) lung cancer treatment and efficacy and (2) recurrence following remission. Furthermore, AnPac Bio believes that compared with many competing methods, CDA technology, which is based on bio-physical signals in the blood, is more cost effective. A summary of the results from this multi-year clinical study are as follows:
– CDA value is a good indicator of a patient’s response to treatment. CDA values are statistically different between complete response (CR) patient group and stable disease (SD) patient group, and between CR patient group and progressive disease (PR) patient group, indicating that CDA could be used for cancer prognosis.
– Patient groups with higher CDA values (higher cancer risk or progression) have statistically lower five-year survival probability than patient groups with lower CDA values (lower cancer risk or progression) which shows that CDA values could be a good indicator predicting the outcome of a treatment (survival probability).
– In a number of cases, CDA values increased ahead of the onset of the cancer’s recurrence, indicating that CDA technology could potentially be used as a recurrence monitor.
Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: “We are very pleased with the positive results from this multi-year, major clinical study. The results show that CDA is not only suited for cancer screening and cancer prevention purposes, but can also be a viable tool for cancer prognosis and recurrence monitoring. Additional clinical studies will be carried out to provide further validation for these encouraging results.”
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Exact Sciences Corp. (NASDAQ: 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.”
Guardant Health, Inc. (NASDAQ: GH) announced last month that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor). The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso® (osimertinib). Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options. “The FDA approval of Guardant360 CDx is a landmark decision, demonstrating the value liquid biopsy delivers to oncologists and more importantly, the patients they treat. Traditional tissue biopsy-based tumor profiling, which is often invasive and has longer turnaround times, can contribute to delays in starting treatment and possibly suboptimal therapy. We applaud the FDA for their collaborative review process and for approving the first comprehensive genomic profiling liquid biopsy test,” said Helmy Eltoukhy, Guardant Health CEO. “We are confident that our FDA approval will help accelerate wider adoption of guideline-recommended genomic profiling, increase the number of advanced cancer patients who receive potentially life-changing treatments, and pave the way for new companion diagnostic developments for the Guardant360 CDx.”
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.”
NeoGenomics, Inc. (NASDAQ: NEO) announced on June 29th, the launch of three liquid biopsy tests for advanced non-small cell lung cancer, all solid tumor types (pan-cancer), and certain breast cancer cases. With the addition of these new testing capabilities, physicians can now rely on NeoGenomics to deliver biomarker information from potentially any patient with a solid tumor or hematologic malignancy even when a tissue biopsy is not possible. “Liquid biopsy testing is an increasingly important tool. Being able to return results for solid tumor patients now means oncologists and pathologists can work with a single laboratory for comprehensive diagnostic and management testing,” said Doug VanOort, CEO of NeoGenomics. “The launch of these three liquid biopsy assays exemplifies our commitment to providing the most comprehensive oncology menu for our clients as a one-stop-shop for their testing needs.”
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