GenScript | November 10, 2020
GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2. The conventional method for measuring neutralizing antibodies requires testing to be performed in a high safety-level facility (BSL3) staffed with specialized personnel. Typically, results from the live virus assay are available in several days and due to the unpredictable nature of the live virus and live cells reagents used, these tests are also difficult to standardize. Results from different facilities may vary, even if performed using the same protocol. In contrast, the cPass™ kit utilizes pure proteins that can be produced in a more reproducible way. The detection of the presence of neutralizing antibodies can also be performed in most standard research or clinical diagnostic laboratories with short turnaround time (~1hr), making it broadly available and much more consistent between different facilities. Furthermore, a comparison of the direct clinical performance between the conventional live virus and the cPass™ assay shows results from both tests are strongly correlated.
Lucid Diagnostics | March 25, 2022
Lucid Diagnostics Inc., a commercial-stage cancer prevention diagnostics company and a majority-owned subsidiary of PAVmed Inc, announced that investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center had enrolled their first patient in a Department of Defense ("DoD")- Katarina B. Greer, M.D., an associate professor of medicine at Case Western Reserve University School of Medicine in Cleveland, is the lead investigator of the research. Lucid supplies the study with EsoCheck® Esophageal Cell Collection Devices and will conduct EsoGuard testing on the obtained samples.
We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study, The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test.”
Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer.
Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer, We hope to demonstrate that a strategy that incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improves endoscopy yield and overall cost-effectiveness.”
Only around 10% of at-risk GERD patients advised for esophageal precancer (BE) screening undergo traditional, invasive upper gastrointestinal endoscopy (EGD). Over 80% of people who undergo EGD screening have a negative result, subjecting the overwhelming majority of these patients to a complicated, invasive, expensive, and inconvenient surgery requiring anesthesia in a specialist procedure center or hospital. EsoGuard has been demonstrated to be 90% sensitive and specific for identifying esophageal precancer and cancer when done on EsoCheck samples, potentially removing the bulk of these negative EGDs, benefiting patients, providers, and the healthcare system.
The trial will include up to 100 Cleveland VA patients who meet the American College of Gastroenterology's criteria for esophageal pre-cancer screening. The research compares two screening strategies: (1) regular EGD screening; and (2) EsoGuard testing followed by EGD exclusively in individuals with a positive EsoGuard result. The trial will determine if utilizing EsoGuard to triage patients to EGD improves overall BE screening rates and decreases the number of EGDs with negative screening results. Additionally, the research will analyze the economic implications for the VA system of these two options.
Cytiva, Pall Corporation | June 02, 2021
Danaher Corporation's Life Sciences platform has acquired precision NanoSystems (PNI). PNI is a global leader in technologies and solutions for developing genetic medicines, including mRNA vaccines and therapeutics. PNI will join Danaher's Life Sciences platform and complement other businesses in the forum, including Cytiva and Pall.
"PNI has advanced several exciting innovations, and we're thrilled to welcome this talented team," says Emmanuel Ligner, Danaher Group Executive. "As mRNA has matured as a successful technology in some COVID vaccines, we see huge potential for this technology to accelerate other therapies. The work done thus far by the PNI team will also enable our customers at Cytiva and Pall to take a huge step forward in advancing their science to improve the lives of patients."
James Taylor, co-founder, and CEO of Precision NanoSystems, says: "Over the last ten years, PNI has been a leading technology company, enabling the development of genetic medicines. Joining Danaher's Life Sciences platform allows our world-class team to accelerate and expand the work we do to support our customers with comprehensive technology platforms and the expertise to manufacture transformative medicines for the benefit of humanity. With the global reach of the Danaher Life Sciences platform and customers who are leaders in biotechnology, this is an incredible opportunity to bring PNI's innovations to market and expand our impact."
The overall mRNA therapeutics and vaccines market was growing rapidly and accelerated with the development of COVID-19 mRNA vaccines. It is anticipated that mRNA technology will be used to develop other vaccines and to treat other conditions of high unmet medical need, such as cancer and genetic diseases.
At present, most mRNA therapies and other types of genetic medicines in clinical development are designed to be delivered with the help of lipid nanoparticles (LNPs). PNI's Genetic Medicine Toolkit, including its proprietary GenVoyTM LNP delivery platform and NanoAssemblrTM microfluidic-based nanoparticle manufacturing platform, enables the rapid development of genetic medicines. PNI's validated technologies increase the stability, efficacy, yield, and quality of non-viral genetic medication and lower the barrier to develop these essential medicines.
PNI is developing a new center of manufacturing excellence in Vancouver, which will proceed as planned. When complete, the biomanufacturing center will further advance Canadian therapeutic and vaccine manufacturing capabilities, broaden the domestic life sciences sector, create new jobs in the region, and foster a new generation of scientific talent.
Pall Corporation may be a filtration, separation, and purification leader providing solutions to meet customers' critical fluid management needs across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety, and environmentally responsible technologies. The Company's engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide.
Cytiva is a global life science leader with more than 8,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency, and capacity to research and manufacture workflows, enabling the development, manufacture, and delivery of transformative medicines to patients.