Thermo Fisher Scientific | September 03, 2021
Thermo Fisher Scientific's clinical sequencing business and AstraZeneca today announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca's expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement.
"As the pipeline of targeted therapies expands, the availability of diagnostic tools that can interrogate multiple biomarkers simultaneously will ensure patients can be matched with the right therapies more rapidly – this is the promise of precision medicine," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Introduction of diagnostic tools early in the process of drug development can further facilitate the success of companion diagnostic development – and that's what we're doing with AstraZeneca."
NGS-based companion diagnostics are increasingly used to match patients with new therapies for cancer and other diseases. More than 90 percent of AstraZeneca's clinical pipeline, across all main areas from oncology, cardiovascular and renal to metabolic and respiratory disease, are targeted precision medicine therapies.
"Using the latest diagnostic science allows us to match the best treatment to the patient," said Ruth March, senior vice president, precision medicine and biosamples, AstraZeneca. "This collaboration with Thermo Fisher offers the technology, expertise and ability to decentralize CDx tests to local healthcare providers across our global markets, which will help us identify more patients around the world who may benefit from treatments and effective patient care."
Thermo Fisher currently offers the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea and the Middle East, and covering more than 550 million lives globally.
To expand global access to a growing list of precision medicine therapies, in 2019 Thermo Fisher introduced the Ion Torrent Genexus System*, the first fully-integrated NGS platform featuring an automated specimen-to-report workflow that economically delivers results in a single day. The company's complete NGS workflow, powered by Ion AmpliSeq technology, includes multiple solutions for solid tumor biomarkers and liquid biopsy testing.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
NAMSA | August 03, 2021
NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early 2021.
Clinlogix, founded in 1999, is well-recognized for providing comprehensive clinical research services for novel and emerging technologies to the medical device industry. Supporting more than 500 trials across 3,500 sites worldwide, Clinlogix provides an unparalleled breadth and depth of global expertise in the areas of Cardiovascular, Neurology, Nephrology, Urology, Oncology and Venous/Wound Care clinical research.
“Today is an exciting day as the Clinlogix Team joins NAMSA. We are thrilled to partner with an organization that is equally committed to client success, evidenced through Clinlogix’s consistent delivery of reliable clinical outcomes to global device Sponsors,” commented NAMSA President and CEO, Dr. Christophe Berthoux. “NAMSA’s 54-year history of providing successful development results, coupled with the clinical expertise and global reach of Clinlogix, now offers medtech innovators a clear choice when seeking safe, accelerated clinical development and commercialization of life-changing medical products,” Dr. Berthoux concluded.
As the pioneer of the medical device testing industry, NAMSA provides testing services to Sponsors in addition to quality, reimbursement, clinical research and regulatory solutions. The CRO’s end-to-end development services are proven to help Sponsors successfully address varying global regulatory requirements, including recently expanded criteria for medical device and In Vitro Diagnostic research and conduct.
“Clinlogix is extremely pleased to join NAMSA, an organization that shares the same patient-centric, client-focused philosophy as we do. For over 20 years, our focus has been on providing a global ‘innovation pathway’ for Clients developing novel and emerging technologies,” stated Clinlogix CEO, JeanMarie Markham. “Now together, with NAMSA, we are expanding and leveraging our respective services to truly provide end-to end development solutions to our Clients,” Markham concluded.
The acquisition of Clinlogix adds to NAMSA’s rapidly growing global footprint, now serving Sponsors throughout 17 locations in Asia-Pacific, Europe, Latin America and North America.
Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s only 100% medical device-focused, full continuum Contract Research Organization (CRO). Driven by its global expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move Clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes.
Clinlogix is a global Clinical Research Organization (CRO) working to improve human quality of life by supporting and accelerating novel and emerging technologies in the life science industry. Its full suite of clinical research services supports the regulatory and clinical development pathway of medical devices, biotechnologies and pharmaceuticals from bench to bedside. The company delivers this global expertise by way of its regional office locations in the U.S., Germany, Colombia and Japan.
Pfizer | December 29, 2020
After a changed, quick spreading variation of COVID-19 in the U.K. disturbed worldwide travel throughout the end of the week, an upsetting inquiry arose: Will the new antibodies from Pfizer and Moderna neutralize this startling new strain of the infection?
Presently the two organizations, alongside Pfizer's COVID-19 accomplice BioNTech, are racing to quiet an apprehensive public. They're dispatching new investigations intended to demonstrate their mRNA-based shots will fight off the new Covid strain, while at the same time communicating certainty this new antibody innovation is ideal for ensuring against quickly changing infections.
Pfizer and BioNTech have tried their antibody "for its capacity to kill various freak strains. Until now, we have discovered steady inclusion of the multitude of strains tried," they said in an assertion. The organizations are currently gathering information from individuals who have gotten the shot to decide how well they "might have the option to kill the new strain from the U.K.," Pfizer added.
Moderna didn't promptly react to a solicitation for input yet said in an assertion gave to other news sources that it expects "that the Moderna immunization instigated insusceptibility would be defensive against the variations as of late portrayed in the U.K.," and that it "will play out extra tests in the coming a long time to affirm this desire."
Pfizer brought up that when SARS-CoV-2, the infection that causes COVID-19, first arose a year prior, it was clear there was more than one strain of it, and that it was transforming as it spread. SARS-CoV-2 is a RNA infection, and all things considered, it has "astoundingly high [mutation] rates" on the grounds that the chemicals it utilizes for replication are "inclined to mistakes when making new infection duplicates," the organization said.
"One reason Pfizer and BioNTech decided to use a mRNA stage is a direct result of the potential for the adaptability of the innovation in contrast with customary immunization advancements," including the capacity to change the RNA arrangement in the antibody, should a strain arise that is not covered by the current shot," Pfizer added.