MEDTECH, INDUSTRIAL IMPACT
QIAGEN | January 06, 2023
QIAGEN recently announced an exclusive strategic partnership with Helix, a California population genomics leader, to advance companion diagnostics for hereditary diseases.
The requirement for companion diagnostic devices and tests capable of detecting clinically relevant genetic abnormalities grows along with the accelerated development of precision medicines. These tests helps in making decisions by showing patients that are most likely to benefit from a specific therapeutic product or be at risk. Although companion diagnostics that use whole exome sequencing have primarily been used in oncology so far, they are widely believed to have a great deal of potential in hereditary disease areas like cardiovascular, metabolic, neurodegenerative, and auto-immune diseases.
According to the agreement, QIAGEN will be Helix’s exclusive marketing and contracting partner in the United States. This partnership will use the Helix® Laboratory Platform, the first whole exome sequencing platform, to get a de novo class II authorization from the U.S. Food and Drug Administration.
As a leader in precision medicine, QIAGEN has more than 30 master partnership agreements with multinational pharma and biotech firms to develop and commercialize companion diagnostic tests for their drug candidates. Its companion diagnostic offerings include next-generation sequencing (NGS), polymerase chain reaction (PCR), and digital polymerase chain reaction (dPCR), sample types ranging from liquid biopsy to tissue, and disease areas such as cancer and Parkinson's, including 11 FDA-approved PCR-based companion diagnostics.
Helix has developed an end-to-end platform that enables health systems, life sciences firms, and payers to enhance genomic research and expedite the integration of genomic data into clinical care. It has teamed with major health systems to enable population genomics programs across the United States. These programs significantly improve the identification and recruitment of patients for clinical trials in hereditary diseases such as Parkinson's and cardiovascular or inflammatory diseases such as non-alcoholic steatohepatitis (NASH).
About QIAGEN
QIAGEN is a leading provider of sample-to-insight solutions, enabling clients to get significant molecular insights from samples containing life's building elements. Its sample technologies are used to isolate and process DNA, RNA, and proteins from blood, tissue, and other materials. The company serves over 500,000 customers worldwide in molecular diagnostics (human healthcare) and life sciences (academia, pharma R&D, and industrial applications, primarily forensics).
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MEDTECH, INDUSTRIAL IMPACT
SOPHiA GENETICS | March 01, 2023
On February 28, 2023, SOPHiA GENETICS, a leading cloud-native software solutions provider in the healthcare space, announced that Synergy Oncology, a part of Synergy Laboratories based in Mobile, Alabama, will utilize SOPHiA DDM™ to develop a new cancer profiling solution. Synergy Oncology is a specialist in innovative platforms that improve patient care.
The use of SOPHiA DDM™ for Hereditary Cancers Solution in Synergy Oncology's state-of-the-art laboratory technologies will lead to the launch of Totality, a comprehensive end-to-end solution for tumor profiling that will assist clinical studies, cancer research and patient care.
Next-generation sequencing (NGS) is commonly used to detect biomarkers for hereditary cancers, but the resulting datasets are vast and complex, requiring sophisticated analysis. The SOPHiA DDM™ for Hereditary Cancers Solution leverages machine learning and Artificial Intelligence (AI) with patented technologies to evaluate raw NGS data, simplifying interpretation and expediting reporting. As Synergy Laboratories seeks to expand into other oncology offerings, the SOPHiA DDM™ platform could serve as a one-stop solution.
Synergy's new product, Totality, examines genes from solid tumor tissue and, by using SOPHiA DDM™ for Hereditary Cancers, provides physicians with a consolidated report that matches detected molecular alterations with clinical trials and FDA-approved therapies. By combining SOPHiA DDM™ for Hereditary Cancers with Synergy Oncology's technology, experts will be able to analyze and interpret findings from NGS data confidently, transforming high-quality data into valuable insights for researchers and care providers.
Synergy Oncology provides the most comprehensive NGS kit of its kind, including hereditary testing, liquid biopsy testing, and myeloid malignancies. The combination of Synergy Oncology and SOPHiA GENETICS technology will expand Synergy's oncology portfolio while helping to further the U.S. oncology market.
About SOPHiA GENETICS
SOPHiA GENETICS is a leading cloud-native software solutions provider in the healthcare space. It aims to establish data-driven medicine as the standard of care for life sciences research. The company combines expertise in life sciences, data computing and medical disciplines to bring data analytics solutions to market. SOPHiA GENETICS achieve its mission through the global adoption of SOPHiA AI, which uses pattern recognition, statistical inference and machine learning to provide equal benefits to all users. SOPHiA AI also encourages expert knowledge sharing for a sustainable impact on future patients. The company believes digital technologies are the key to unlocking the era of Data-Driven Medicine, where secure data pooling and knowledge sharing will be precious for patients. The company also focuses on combining the first two pillars of Data-Driven Medicine, Radiomics and Genomics, to ensure that the data used to help patients today will also benefit tomorrow's patients.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
The Center for Breakthrough Medicines | March 13, 2023
Nucleus Biologics and Stoic Bio have teamed up to form a supply agreement with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization that aims to accelerate the development and manufacture of advanced therapies. Under the agreement, Nucleus Biologics will become CBM's selected supplier of cell culture media and other biological solutions, ensuring a consistent supply of this critical material with tighter quality control measures.
Nucleus Biologics' approach to cell culture media, which sees it as a critical raw material that can drive desired attributes of cells crucial to the success of cell and gene therapy research, is complementary to CBM's focus on transparency, technology, and end-to-end solutions. By working together, they hope to expedite cell and gene therapy breakthroughs.
In addition, CBM will be an early adopter of Stoic Bio's innovative family of point-of-use media makers, Krakatoa™, which allows scientists to manufacture their own media with 65% fewer CO2 emissions than conventional media. By demonstrating that developing and manufacturing lifesaving therapies doesn't have to come with a high environmental cost, CBM hopes to set an example for the industry.
With over 2,200 cell and gene therapies in development, collaborations like this one are needed to speed up the process of getting these therapies to the clinic and ultimately approved. The CBM, Stoic Bio and Nucleus Biologics collaboration aim to create a unique service offering that introduces a paradigm shift in development and manufacturing, showing how technology and sustainability can converge to make better therapies sustainably.
About The Center for Breakthrough Medicines
The Center for Breakthrough Medicines (CBM) is a CDMO focused on accelerating the development and manufacture of advanced therapies to save lives. It offers end-to-end solutions such as process development, manufacturing, and quality control for cell and gene therapies, gene editing, and immunotherapies. In addition, CBM collaborates with pharmaceutical companies, academic institutions, and healthcare providers to make advanced therapies more accessible while ensuring compliance with regulatory standards. The company also prioritizes sustainability by implementing green initiatives and sustainable technology and strives to positively impact the communities it operates in.
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