Prenetics Owned ACT Genomics Receives FDA Clearance for ACTOnco, the First Asia-Based Company to Receive Clearance for a Comprehensive Genomic Profiling Test for All Solid Tumors ACN Newswire

Prenetics Owned ACT Genomics Receives FDA Clearance for ACTOnco, the First Asia-Based Company to Receive Clearance for a Comprehensive Genomic Profiling Test for All Solid Tumors

11 1 月, 2023
LONDON AND HONG KONG, Jan 11, 2023 - (ACN Newswire via SEAPRWire.com) - Prenetics Global Limited (NASDAQ: PRE) a leader in genomic and diagnostic testing, today announced that ACT Genomics, a company which Prenetics recently acquired a majority stake in, has received clearance from the U.S. Food and Drug Administration (FDA) for ACTOnco, the company's comprehensive genomic profiling test for solid tumors. ACTOnco is intended for use by healthcare professionals to help them inform clinical management decisions in accordance with professional guidelines for cancer patients with solid tumors. This is the first and only Asia-based company to receive FDA clearance for a comprehensive genomic profiling test. ACTOnco is a diagnostic test which:-- provides a comprehensive genomic profiling test that looks at 440 cancer-associated genes;-- provides information to help guide clinical management decisions on the use of targeted oncology therapies, including immunotherapies;-- is intended as a pan-cancer test including breast, colon, endometrial, lung, and other cancers;-- is an FDA-cleared platform for comprehensive genomic profiling assay development for biopharma companies developing precision therapeutics.The ability to perform a comprehensive genomic profiling test on an individual tumor helps open the door for personalized medicine, and a future where a person is matched with a treatment that targets the specific weaknesses in his or her cancer."Today's landmark clearance by the FDA represents a significant advancement in personalized cancer care in Asia and may lead to reimbursement and coverage by private insurers and healthcare systems. The clearance by the FDA further validates our status as a pioneer in the industry and we will continue to invest further in R&D efforts, especially related to early detection of cancer in healthy populations." Said Danny Yeung, Chairman of ACT Genomics and Chief Executive Officer of Prenetics. Dr. Hua Chien Chen, Chief Executive Officer of ACT Genomics, said "It was a tremendous team and scientific effort to develop ACTOnco. Asia contributes 48% of the new cancer cases and 55 % of the cancer deaths in the world. The disease imposes a serious burden on Asia. While precision medicine provides an advantage in disease diagnosis and treatment planning and has become a routine clinical practice in the west, it is not the case in Asia. ACT Genomics is the first biotech company in Asia that received market authorization for a cancer comprehensive genomic profiling assay. Unlike most of the currently marketed tests developed by US companies using mainly clinical samples from Western countries, the ACTOnco assay was developed and validated using half of the Western clinical samples and half of the Asia clinical samples. ACTOnco enables physicians to gain better insights into the genetic underpinnings of each patient's illness and helps them to formulate the best treatment decisions. Having ACTOnco cleared by the FDA will open new opportunities for patients to get the best cancer care. With this incredible milestone achieved, we will continuously promote precision medicine in Asia and our company mission to turn genomics into action." About ACT GenomicsACT Genomics is an innovation-driven cancer solution provider with offices in Taipei, Hong Kong, Singapore, Tokyo, Bangkok, and the United Kingdom. With its Next-Generation Sequencing (NGS) technology, CAP-accredited laboratories, experienced bioinformatics team, and proprietary AI algorithms, ACT Genomics provides optimal cancer treatment planning, immunotherapy evaluation, cancer relapse & drug resistance monitoring, as well as cancer risk assessment services to medical professionals. Its mission is to "Turn Genomics into Action". To learn more about ACT Genomics, visit www.actgenomics.com.About PreneticsFounded in 2014, Prenetics is a major global diagnostic and genetic testing company with the mission to bring health closer to millions of people globally and decentralize healthcare by making the three pillars - Consumer Health, Clinical Care and Medical & Cancer Genomics - comprehensive and accessible to anyone, at anytime and anywhere. Prenetics is led by visionary entrepreneur, Danny Yeung, with operations across nine locations, including the United Kingdom, Hong Kong, India, South Africa, and Southeast Asia. Prenetics develops consumer genetic testing and early colorectal cancer screening and provides COVID-19 testing, rapid point of care and at-home diagnostic testing and medical genetic testing. Prenetics is listed on NASDAQ with the ticker PRE. To learn more about Prenetics, visit www.prenetics.com.Investor Relations Contact:investors@prenetics.comICR Westwicke:Caroline Corner +415 202 5678 Email: caroline.corner@westwicke.comForward-Looking Statements In addition to historical information, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. These statements are based on estimates and forecasts and reflect the views, assumptions, expectations, and opinions of Prenetics and ACT Genomics. Any such estimates and assumptions, expectations, forecasts, views or opinions, whether or not identified in this press release, should be regarded as indicative, preliminary and for illustrative purposes only and should not be relied upon as being necessarily indicative of future results. These statements include, but are not limited to, statements by our management or the board regarding expectations for the closing of the acquisition, statements of plans, objectives, and expectations of synergy between Prenetics and ACT by our management or the board or by ACT or ACT's management or board. Our expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Because of these uncertainties, you should not make any investment decisions based on our estimates or forward-looking statements. All information provided in this press release is as of the date of this press release. Prenetics does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as required under applicable law. Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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Dammam Valley and Arcensus GmbH to establish Saudi-German Genomic Center in Riyadh ACN Newswire

Dammam Valley and Arcensus GmbH to establish Saudi-German Genomic Center in Riyadh

8 9 月, 2022
DAMMAM, SAUDI ARABIA, Sep 8, 2022 - (ACN Newswire via SEAPRWire.com) - Dammam Valley, in partnership with other investment partners, and Arcensus GmbH announce the establishment of a high-throughput Saudi-German Genomic Center in Riyadh. The Saudi-German Genomic Center will begin operations immediately, providing comprehensive genomic diagnostic services for the GCC region based on exclusive next-generation sequencing technologies.Based on the expertise of a cross-functional, international team of geneticists, medical experts, and data scientists, the Riyadh center will reflect one of the world's most innovative genetic biotechnology organizations, provide its knowledge to clinical colleagues, collaborate with all medical decision-makers, and support the further improvement of the Saudi healthcare infrastructure in line with the Saudi Health Vision 2030. In addition, the partners believe that with the global adoption of Whole Genome Sequencing as the first line of genetic testing, the genomic era will begin in full force and conquer the molecular medicine market in a short period of time.The initiative to establish this state-of-the-art genomic center stems from the Kingdom's goal to accelerate the implementation of genetic testing for the early diagnosis of diseases, particularly cancer and rare genetic disorders, but also address the preventive element in personalized medicine. The financial investment led by Dammam Valley will enable the partners to penetrate regional markets faster with their innovative solutions.Dr. Abdulrahman Al-Olayan, CEO of Dammam Valley, said, "The establishment and short-term opening of a state-of-the-art genetic center is central part of the Saudi Vision 2030 and a key element to establishing knowledge and expertise in the region. Furthermore, it is a crucial element in the continuous improvement of the regional healthcare systems to the benefit of the entire population. All the knowledge we accumulate here will be used in the next step for the strategic development of a dynamic and vital pharmaceutical and biotech scene. We are pleased to have Arcensus GmbH as an internationally experienced partner at our side. Especially for the Arab world it is a great pleasure to have Dr. Arndt Rolfs, a highly accomplished, experienced and visionary multi-entrepreneur as a partner."Dr. Arndt Rolfs, Arcensus Founder and CEO, said, "Especially after Dammam Valley's investment in the company I founded in 2020, Arcensus GmbH, it is a logical and purposeful step to go along the path of establishing a regional center for improving genomic diagnostics with such a proven and reliable partner. The Arab countries have the challenge of improving the early and targeted diagnosis of the numerous genetic diseases. But exactly this knowledge, which can be developed here with the local medical partners, can also serve to establish a dynamic and creative regional and, in a further step, international biotech scene. We are extremely pleased to be able to contribute with our knowledge to this success in the coming years."Under the terms of the agreement, Dammam Valley along with other investors, will make a substantial investment in establishing the Saudi-German Genomic Center. The parties agree that Arcensus will fully operate the center. The integrity of the protected patient data will be maintained, as will the dedicated sales, marketing and life science business activities.About Dammam ValleyEstablished in 2021, Dammam Valley is a semi-government Investment company, solely owned by Imam Abdulrahman bin Faisal University in Damman, Saudi Arabia, with a raised capital of 100,000,000 SAR. It strives to be a source and destination for biotechnology innovation and healthcare in the Middle East and is the Nation's premier hub for evaluating and incubating biotech innovations. It aims to stimulate investment, support projects, and forge quality partnerships in the fields of Health & Biotechnology, in addition to focusing on numerous other sustainable investments in various fields of interest. Please see https://dammamvalley.sa/.About Arcensus GmbHArcensus GmbH is a digital healthcare and diagnostics company that empowers people to take control of their health. The company provides the highest-standard, secure, trusted, and comprehensive diagnostic service based on Whole Genome Sequencing. Arcensus analyses the complete genetic information in human DNA and identifies the predispositions and reasons for unclear symptoms with the help of cutting-edge bioinformatic technology, including artificial intelligence. The interpretation of the genomic data suggests better treatment options and helps individuals take preventive measures to live a healthier and longer life. From offices in New Jersey, U.S., and Rostock and Berlin, Germany, a cross-functional team of genetic experts, medical doctors, and data scientists works to make the most sophisticated and best genetic interpretation with medical and health prevention applications accessible to everyone. Please visit https://arcensus-diagnostics.com/.Contact information:Arcensus GmbHAhmad MalikCommunication ManagerEmail: Ahmad.malik@arcensus-diagnostics.comDammam ValleyDalal AlsarawiCommunication ManagerTel: +966 13 333366Email: dalal.alsarawi@dammamvalley.saThis press release is issued through EmailWire(TM) (www.emailwire.com) - the global newswire service that provides Press release distribution with guaranteed results. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Dammam Valley/KSA to acquire the majority of Arcensus GmbH/Germany to accelerate the global implementation of Whole Genome Sequencing in genetic diagnostics and delivery of breakthrough technologies in genomic bioinformatics ACN Newswire

Dammam Valley/KSA to acquire the majority of Arcensus GmbH/Germany to accelerate the global implementation of Whole Genome Sequencing in genetic diagnostics and delivery of breakthrough technologies in genomic bioinformatics

6 9 月, 2022
ROSTOCK, Germany & DAMMAM, KSA, Sep 5, 2022 - (ACN Newswire via SEAPRWire.com) - Dammam Valley in partnership with other investment partners, announce to acquire a majority stake in Arcensus GmbH/Germany. Arcensus, founded by Dr. Arndt Rolfs, a multi-entrepreneur in biotechnology, CEO and founder of several innovative biotech companies, is a digital health and diagnostics company providing comprehensive genomic diagnostic services based on Whole Genome Sequencing.With a cross-functional, international team of geneticists, medical experts and data scientists, Arcensus, one of the world's most innovative genetic biotechnology companies, offers its knowledge and bioinformatic expertise in genomic interpretation together with cutting-edge medical and preventive health applications. The management of Arcensus is convinced that with the worldwide implementation of Whole Genome Sequencing as the first line of genomic testing, the genomic era will start quickly and will conquer the molecular medicine market in a short time.The initiative for the take-over comes from the Kingdom's aim to improve the global speed in implementing genomic testing for the early diagnosis of genetic diseases, mainly in cancer and rare genetic disorders. The financial investment led by Dammam Valley will allow Arcensus to speed up the penetration of the worldwide markets with its innovative solutions. It will be the backbone for developing a comprehensive multi-omic strategy.Dr. Abdulrahman Al-Olayan, CEO of Dammam Valley said, "This is an important step in our global healthcare strategy for KSA, as we believe that the early diagnosis and preventive testing based on real-life genomic expertise with Whole Genome Sequencing is a key ingredient to accelerate the development of, and access to, new future treatments. As a leading technology company in genomic testing, Arcensus GmbH, founded by the visionary multi-entrepreneur, Dr. Arndt Rolfs, is best positioned to provide a deep understanding of bioinformatic technologies and data analytics infrastructure needed not only for the Kingdom of Saudi Arabia but for medical research and development efforts across the globe. A key principle of this is to preserve Arcensus' autonomy. We are delighted that the founder of Arcensus, Dr. Arndt Rolfs, will continue to manage operations, sit on the board and remain a significant shareholder."Dr. Arndt Rolfs, Arcensus founder and CEO, said, "Dammam Valley will be a tremendous partner for the global expansion to us and shares our vision for building a worldwide healthcare platform in modern preventive medicine as well as early diagnostics of all genetic diseases. This important partnership will allow us to increase the investments in our modern technology and services platform, as well as our knowledge-based data extraction of the genomic data."Under the terms of the agreement, Dammam Valley along with other investors will make a double-digit million Euro payment on a fully diluted basis. The parties agree Arcensus to continue its current business model, a network of partnerships and overall objectives following the transaction's closing. The integrity of the proprietary patient data will be maintained, as will the dedicated sales, marketing, and life sciences business activities.About Dammam ValleyEstablished in 2021, Dammam Valley is a semi-government Investment company, solely owned by Imam Abdulrahman bin Faisal University, and with a raised capital of 100,000,000 SAR. It strives to be a source and destination for biotechnology innovation and healthcare in the Middle East and is the Nation's premier hub for evaluating and incubating biotech innovations. Aiming to stimulate investment, support projects, and forge quality partnerships in the fields of Health & Biotechnology, in addition to focusing on numerous other sustainable investments in various fields of interest.About ArcensusArcensus is a digital healthcare and diagnostics company that empowers people to take control of their health. The company provides the highest-standard, secure, trusted, and comprehensive diagnostic service based on Whole Genome Sequencing. Arcensus analyses the complete genetic information in human DNA and identifies the predispositions and reasons for unclear symptoms with the help of cutting-edge bioinformatic technology, including artificial intelligence. The interpretation of the genomic data suggests better treatment options and helps individuals take preventive measures to live a healthier and longer life.From our offices in New Jersey - United States, Rostock and Berlin - Germany, a cross-functional team of genetic experts, medical doctors, and data scientists works to make the most sophisticated and best genetic interpretation with medical and health prevention applications accessible to everyone. For more information, visit https://arcensus-diagnostics.com/.Important Notice and DisclaimerThis press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws. Statements contained herein that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "continues," "expect," "estimate," "intend," "project," and similar expressions and future or conditional verbs such as "will," "would," "should," "could," "might," "can," and "may," are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause Arcensus' actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates, our ability to streamline cash usage, our requirement for additional financing and our ability to continue as a going concern, or other factors.Contact information:Arcensus GmbHAhmad Malik Communication ManagerTel: +49 381 20267000 Email: Ahmad.malik@arcensus-diagnostics.com Dammam Valley Dalal AlsarawiCommunication ManagerTel: 013 333366Email: dalal.alsarawi@dammamvalley.sa www.dammamvalley.saThis press release is issued through EmailWire(TM) (www.emailwire.com) - the global newswire service that provides Press release distribution with guaranteed results. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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