NEW YORK, Aug. 3, 2020 /PRNewswire/ -- Cancer biomarkers have gained significant importance in the drug-development process in recent years. In particular, microarray technologies provide analysis of tens of thousands of molecules for a variety of assays, including drug binding, molecular interactions, enzyme activity and pathway identification. According to a research by BCC Publishing, these microarrays, which include DNA microarrays, protein microarrays, tissue microarrays, low complexity microarrays and carbohydrate microarrays, are excellent tools for gene expression profiling, biomarker profiling and diagnostics. As a result, pharmaceutical and biotechnology companies and researchers use these microarrays to modernize drug target identification and testing. Furthermore, the swift growth in the clinical research and diagnostic devices markets has strong influence on applications of microarray technology, including for clinical trials and diagnostic devices. And, data by BBC Publishing specifies that the global market for cancer profiling technologies should grow from USD 45.2 Billion in 2018 to USD 90.6 Billion by 2023 while experiencing a compound annual growth rate (CAGR) of 14.9% for the period of 2018-2023. AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC), Seattle Genetics, Inc. (NASDAQ: SGEN), Bristol-Myers Squibb Company (NYSE: BMY), NeoGenomics, Inc. (NASDAQ: NEO), Merck & Co., Inc. (NYSE: MRK)
Early diagnosis is crucial for improving chances of survival in cancer patients. Over the decades, great strides in oncology diagnostics technology have been achieved. For example, a new research published in Nature Communication Biology indicates that a way of identifying cancer biomarkers has been developed by researchers at Lund University in Sweden. The new technology allows very sensitive, quick and cost-effective identification of cancer biomarkers. Professor Carl Borrebaeck, director of CREATE Health Cancer Center at Lund University explained that, "We have for years been developing advanced diagnostic approaches for multiplexed analysis of serum proteins, using a single drop of blood, for the purpose of early diagnosis of complex disease, in particular cancer. There is massive amount of information in blood and our combination of proteomics and genomics will open up for rapidly associating early tumor development with protein signatures. This in turn will benefit the patients with a more favorable outcome and overall survival. We are very excited with this novel next generation of biomarker discovery tool."
AnPac Bio-Medical Science Co., Ltd. (NASDAQ: ANPC) announced breaking news last week 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."
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Seattle Genetics, Inc. (NASDAQ: SGEN) reported back in April an update on the phase 1b/2 multicohort EV-103 trial (also known as KEYNOTE-869) of PADCEVTM (enfortumab vedotin-ejfv) in combination with anti-PD-1 therapy pembrolizumab for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. Based on recent discussions with the U.S. Food and Drug Administration (FDA), data from the randomized cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States. PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. "We are excited that EV-103 provides PADCEV with a potential pathway for U.S. accelerated approval in first-line metastatic urothelial cancer," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "Our initial data on the combination of PADCEV and pembrolizumab in previously untreated patients who could not receive cisplatin are encouraging."
Bristol-Myers Squibb Company (NYSE: BMY) announced back in May that Opdivo
(nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.1 The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.1 This application was reviewed under the FDA's Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.2 On May 15, the FDA approved Opdivo + Yervoy as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L1≥1% as determined by an FDA-approved test.
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."
Merck & Co., Inc. (NYSE: MRK) announced last month that the U.S. Food and Drug Administration (FDA) had accepted two new supplemental Biologics License Applications (sBLAs) for KEYTRUDA, Merck's anti-PD-1 therapy. The FDA has accepted and granted priority review for a new sBLA seeking accelerated approval for KEYTRUDA in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), based on the Phase 3 KEYNOTE-355 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 28, 2020. The FDA also accepted for standard review a new sBLA for KEYTRUDA for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as neoadjuvant treatment, and then as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. The PDUFA date for this application is March 29, 2021. "There is a real need to advance new treatment options for triple-negative breast cancer, an aggressive form of the disease. The FDA's acceptance of these KEYTRUDA applications for review is an important step toward helping patients with both early-stage and metastatic disease," said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
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