INDUSTRIAL IMPACT, MEDICAL
Molecular Assemblies, Inc. | March 15, 2023
On March 14, 2023, Molecular Assemblies, Inc., a leading life sciences company, made a significant announcement regarding its enzymatic DNA synthesis technology. The company has successfully shipped the first enzymatically synthesized oligonucleotides to leading researchers in biotechnology, academic, and synthetic biology. The capacity to synthesize lengthy, extremely pure DNA promptly utilizing a proprietary Fully Enzymatic Synthesis (FES) technology solves critical unmet demands in DNA synthesis, thus allowing demanding and high-value applications such as CRISPR gene editing.
Long, highly pure single-stranded oligonucleotides are critical in various applications, such as CRISPR gene editing tools used in therapeutic development, research discovery and protein engineering. However, the availability of desired sequences required to make advanced edits has been a significant bottleneck.
Molecular Assemblies' Key Client Program gives chosen researchers priority access to lengthy and customized oligonucleotides synthesized utilizing the company's FES technology. Thanks to this initiative, customers are expected to speed up their research in CRISPR gene editing and other applications needing long oligonucleotides. In addition, key customers can give input to shape the future of enzymatic DNA synthesis. Molecular Assemblies plans to present more details about the technology at the SynBioBeta 2023 conference in Oakland, California, from May 23-25.
Molecular Assemblies' President and CEO Michael J. Kamdar commented, "With the achievement of this significant commercial milestone, we are proving that fully enzymatic synthesis can deliver the DNA that customers want today, without compromise," He further emphasized, "Customers want application-ready DNA, unrestricted by length and sequence-complexity, which we know is essential to power new breakthroughs in scientific research and accelerate innovation for many industries, including next generation medicines and technologies."
(Source – PR Newswire)
About Molecular Assemblies, Inc.
Molecular Assemblies, Inc. is a leading company dedicated to developing enzymatic DNA synthesis technology to address key challenges in DNA synthesis. Its proprietary Fully Enzymatic Synthesis (FES) technology aims to provide an innovative solution to produce long, pure DNA quickly, efficiently, and sustainably. As a result, molecular Assemblies' FES technology has the potential to transform the field of DNA synthesis by enabling the production of high-quality, long oligonucleotides. This development has significant implications for research discovery, therapeutic development, and protein engineering, particularly in the context of CRISPR gene editing. The company was founded in 2013 and is headquartered in San Diego, California. It has received significant funding from various sources, including venture capital firms, angel investors, and government agencies.
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MEDTECH, INDUSTRIAL IMPACT
Prnewswire | April 06, 2023
ConcertAI, LLC a leader in AI Software-as-a-Service (SaaS) technology and Real-world Evidence solutions for life sciences and healthcare, announced the release of its next generation of Clinical Trial Optimization (CTO 2.0).
"Trial sponsors have a range of new imperatives they're trying to meet: assuring that the trial population is reflective of the ultimate population that would have access to the drug; to set and meet diversity goals for those ethnic, racial and economic groups that are uniquely, negatively impacted by a disease; and meeting ever higher productivity imperatives for identifying and activating sites faster and working with those sites most likely to accrue to the pre-activation feasibilities," said Jeff Elton, Ph.D. CEO of ConcertAI. "Meeting these goals requires working with sites and investigators not historically preferred, designing trials for a minimum of burden on research sites and patients and, perhaps most importantly, moving more studies into community-based research settings."
CTO 2.0 now includes a range of features: (1) clinical depth and tools, such as line of therapy assessments, Kaplan-Meier survival curves, and cox-proportional hazard assessments that guide alternative designs with the largest underlying research dataset for oncology; (2) data integrating electronic medical-derived, medical claims, and social determinants of health; (3) site- and investigator-level information on current and previous clinical trials derived from public and private sources; and (4) operational trial metrics and site profile information to highlight performance and capabilities.
The solution's foundation is a study digitization layer that can handle any depth of inclusion and exclusion (I/E) criteria. Protocols can be assessed relative to standard-of-care in different settings and in different time periods, all the way down to the individual event or clinical activity level. There are APIs for integrating past study protocols from any legacy systems of records. Optimizer and recommendations engines can provide study-level optimizations and semi-automate site selection. Additional APIs can integrate past site survey data and investigator databases as a means of simplifying and unifying what are often non-integrated solutions within the clinical analytics and clinical operations organization. The SaaS technology will support researchers and clinicians in selecting the most appropriate sites for clinical trials, balancing potential patients available and previous trial performances at those sites to give the highest likelihood of success for a clinical trial. In assurance that trials can be conducted across settings and utilize the latest digital trial solutions that support direct EMR to EDC, CTO 2.0 leverages the latest clinical informatics integrations and data standards to ensure research can be conducted at scale and meeting, or exceeding, enhanced standards of care.
"In the past, clinicians used previously published protocols and recently approved studies in the same disease to inform trial designs for new studies," said Ronan Brown, ConcertAI's Chief Operating Officer. "Now that is changing. We'll now see greater reliance on large scale, multi-sourced, clinical datasets that have low latency, reflecting the latest treatments, supporting new designs, lower site burden, greater, diversity, and expanded views of relevant sites. It's a significant step forward in clinical trial planning and operations."
About ConcertAI
ConcertAI is a leader in Real-World Evidence (RWE) and AI technology solutions for life sciences and healthcare. Our mission is to accelerate insights and outcomes for patients through leading real-world data, AI technologies, and scientific expertise in partnership with the leading biomedical innovators, healthcare providers, and medical societies.
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MEDTECH, INDUSTRIAL IMPACT
Globenewswire | April 13, 2023
Centogene N.V. the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the launch of NEW CentoGenome®, an enhanced Next Generation Sequencing (NGS)-based assay. Healthcare professionals can leverage NEW CentoGenome to provide more comprehensive diagnostic information, which could accelerate access to potential treatment options.
Serving as a first-line test, NEW CentoGenome is the most comprehensive commercially available Whole Genome Sequencing (WGS) test on the market for both rare and neurodegenerative disorders – covering almost all disease-causing variants, including the most relevant repeat expansions associated with neurological diseases, in a single assay. NEW CentoGenome also detects Copy Number Variations (CNVs) associated with Spinal Muscular Atrophy (SMA), as well as complex disease-causing variants associated with Gaucher Disease (GD) and susceptibility to GBA1-related Parkinson's Disease (PD), with the highest levels of sensitivity.
The newly designed WGS assay leverages a Polymerase Chain Reaction (PCR)-free approach. This significantly diminishes the typical bias induced by PCR and provides higher quality sequencing data across the typically challenging regions of the genome by enabling more uniform coverage and superior performance in variant detection.
“As a pioneer of genetic diagnostics, we are committed to enabling access to high-quality diagnostics and ensuring that cutting-edge data analyses are available to support better patient health outcomes,” said Prof. Peter Bauer, Chief Medical and Genomic Officer at CENTOGENE. “Building on this expertise, CENTOGENE’s enhanced whole genome sequencing is the leading solution on the market, reflecting the latest advanced technologies and unique insights that can’t be found anywhere else to provide maximized disease coverage. Ultimately, this will provide physicians with an unparalleled level of certainty when diagnosing, prognosing, and treating patients.”
CENTOGENE’s NEW CentoGenome - Superior Technology With Market-Leading Clinical Coverage in a Single Test
CENTOGENE’s enhanced WGS solution consists of three seamlessly integrated key features
Advanced Technology for Greater Insights
Implementing PCR-free technology to significantly reduce bias and provide high-quality sequencing information for difficult-to-sequence genetic regions – enabling greater insights into coding, regulatory, and intronic regions
Superior Performance for Enhanced Disease Coverage
Delivering superior performance in variant detection thanks to CENTOGENE’s automated CE-IVD bioinformatics pipeline and medical expert-based analysis of the CENTOGENE Biodatabank, which consists of approximately 700,000 patients representing over 120 highly diverse countries
Integrated Variant Reclassification and Confirmatory Testing for a Life-Long Commitment to Patients
Demonstrating CENTOGENE’s unique commitment to improving the lives of patients with rare and neurodegenerative diseases, NEW CentoGenome is paired with life-long diagnostic support and a free-of-charge and proactive diagnosis confirmation and reclassification program
About CENTOGENE
CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
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