Biotechnology Leader LuminUltra Submits COVID-19 Clinical Diagnostic Testing Kit for Regulatory Authorization in U.S., Canada

LuminUltra | September 14, 2020

Canada-based biotechnology front-runner LuminUltra announced today that it has submitted its GeneCount® COVID-19 RT-qPCR Assay Kit (COVID-19 Assay) to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and to Health Canada for an Interim Order (IO). With authorization to use this key testing component, LuminUltra, a leader in field-based molecular diagnostic testing for over 20 years, will provide a complete clinical COVID-19 testing solution that can be customized for testing facilities throughout North America. LuminUltra's accurate GeneCount® COVID-19 RT-qPCR Testing Solution comprises multiple components that together make up an end-to-end solution, including: sample collection kits; isolation reagents; the COVID-19 Assay; and a range of quick-detection qPCR testing devices with software for simple interpretation of COVID-19 test results in under two hours. With the authorization of the COVID-19 Assay, LuminUltra will be able to offer flexibility to appropriate facilities around the world by providing some or all of the necessary COVID-19 testing components from a single, reputable company. This reduces the need to source components from multiple suppliers, allowing facilities to onboard additional testing capacity quickly. Underscoring its reliable supply chain, LuminUltra responded promptly to the Government of Canada's testing needs earlier in the year, and has been a key supplier of the isolation reagents for the national testing program since April, providing 500,000 tests a week.

Spotlight

To convert a piece of cloned DNA into a centromere-containing human artificial chromosome (HAC), an array of repeated LacO sequences is incorporated into the DNA.

Spotlight

To convert a piece of cloned DNA into a centromere-containing human artificial chromosome (HAC), an array of repeated LacO sequences is incorporated into the DNA.

Related News

CELL AND GENE THERAPY

Terumo Blood and Cell Technologies to Collaborate with CSL Plasma on U.S. FDA Clearance of Plasma Collection Technology

CSL Plasma | March 11, 2022

CSL Plasma, a division of global biotherapeutics pioneer CSL Behring, announced the Rika Plasma Donation System created by Terumo Blood and Cell Technologies, a medical technology company based in Lakewood, Colorado, has received regulatory approval. The new plasmapheresis system is expected to provide technologies to support a safe, efficient, and better experience for plasma donors and an improved experience for CSL Plasma personnel, according to Terumo Blood and Cell Technologies. Additional characteristics of the new Rika system, according to CSL Plasma, will allow for the collection of more plasma in less time, hence improving quality and safety and, in turn, better serving patients who rely on plasma-based therapies. These advantages include: On average, Rika completes one plasma collection in 35 minutes or less: Compared to previous average CSL Plasma donation timings, this might mean a nearly 30% reduction in donor donation time. It assures that no more than 200 milliliters of blood are ever removed from the donor's body. This is believed to make the donor more comfortable during the donation process and lessen the risk of red cell loss deferral. It has a sophisticated user interface that helps CSL Plasma front-line personnel operate the equipment. This milestone helps bring to life how we demonstrate innovation, collaboration, and patient-focus, part of the CSL Values that underpin our commitment to manufacturing and delivering life-saving and life-extending medicines around the world, We continue to evolve as a leading biotechnology company, investing in our core plasma business. Continued innovation that benefits our employees and plasma donors speak to how we are driven by our promise to save and improve lives around the world." CSL Chief Operating Officer Paul McKenzie. CSL Plasma will begin installing the new technology at locations in the Denver, Colorado, area in the following months. There is a critical and ongoing need for human plasma to produce life-saving medicines for people with serious and rare diseases, CSL Plasma's decision to work with Terumo Blood and Cell Technologies is consistent with our business goals to improve the donor and employee experience through innovation and remain the plasma donation center of choice. We look forward to rolling out this new technology." CSL Plasma General Manager Michelle Meyer.

Read More

MEDICAL

Peptilogics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Trial of PLG0206 in Periprosthetic Joint Infection

Peptilogics | January 11, 2022

Peptilogics, a biotech company that engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases, announced that the U.S. Food and Drug Administration as accepted the company's Investigational New Drug Application for PLG0206 to treat periprosthetic joint infection allowing the Phase 1b study to proceed. Peptilogics will evaluate the safety and efficacy of PLG0206 in a Phase 1b open-label, dose-escalating study in patients undergoing debridement, antibiotics and implant retention surgery for the treatment of PJI occurring after total knee arthroplasty. “PJI is a devastating condition with limited treatment options, since systemic antibiotics frequently fail to eliminate the infection and surgery to remove the infected hardware is then required. Based on our promising preclinical efficacy and healthy volunteer Phase 1 study data with PLG0206, we are excited to explore its safety and efficacy as a potential treatment for patients with PJI.” Jonathan Steckbeck, Ph.D., Founder and CEO of Peptilogics PLG0206 is an investigational broad-spectrum, anti-biofilm, anti-infective peptide therapeutic. The current standard of care for PJI includes numerous high-risk surgical procedures coupled with systemic antibiotic treatment, which are often ineffective due to device-associated biofilms. PLG0206 was designed with a unique mechanism of action that allows it to directly addresses biofilm bacteria and persistent pathogens that evade standard of care antibiotics by targeting and disrupting bacterial membranes to trigger bacterial cell death. PLG0206 has demonstrated best-in-class, rapidly bactericidal, broad-spectrum activity against a variety of pathogens, regardless of resistance phenotype, identified by the World Health Organization and the Centers for Disease Control as critical, urgent or high priority targets. PLG0206 has previously been granted FDA Orphan Drug Designation for the treatment of PJI and has been designated as a Qualified Infectious Disease Product (QIDP) as well. In December, Peptilogics announced the publication of two peer-reviewed studies on PLG0206. Data from a first-in-human Phase 1 study of PLG0206, published in Antimicrobial Agents and Chemotherapy, showed the investigational therapeutic was safe and well tolerated and has favorable pharmacokinetics when intravenously administered as a single dose. These data were presented in September at ID Week. Data from a clinical proxy study of PLG0206, published in Microbiology Spectrum, showed the investigational therapeutics’ ability to reduce bacteria on chronically infected prosthetic knee joints, which may translate to improved clinical outcomes. About Periprosthetic Joint Infection (PJI) More than one million total joint replacements are performed annually in the U.S., a number that is expected to grow to four million annual procedures by 2030 due to an aging and active population. Following joint replacement, 1-2% of patients will develop a PJI, a serious life-threatening condition which often necessitates continuous antibiotic usage and high-risk surgical procedures with limited ability to resolve the infection. The current standard of care has up to a 60% failure rate and results in a substantial number of patient deaths, evidenced by a 25% five-year mortality rate. About Peptilogics Peptilogics engineers peptide therapeutics to radically improve the treatment landscape for patients with life-threatening diseases. Through biological and pharmaceutical expertise, novel artificial intelligence algorithms, and purpose-built super-computing, Peptilogics is developing an extensive therapeutic pipeline and accelerating discovery efforts at a pace and scale that was previously impossible. Peptilogics is backed by visionary investors in life science and technology including Peter Thiel, Presight Capital, CARB-X, and Founders Fund.

Read More

CELL AND GENE THERAPY

Thermo Fisher Scientific Announces its Complete Acquisition of Mesa Biotech

Thermo Fisher Scientific | March 01, 2021

Thermo Fisher Scientific Inc. (NYSE: TMO), the world chief in serving science, today reported it has finished its recently declared obtaining of Mesa Biotech, Inc., a secretly held purpose of-care sub-atomic analytic organization. Plateau Biotech has built up the Accula System, a moderate, simple to-utilize, purpose of-care PCR-based testing stage for irresistible infection conclusion. The stage empowers fast, exceptionally precise testing at doctor workplaces, drug stores and different settings, giving outcomes quickly. Past COVID-19 testing, Mesa Biotech's current stage incorporates tests for influenza, respiratory syncytial infection (RSV), and Strep A. "The Accula System complements our existing offerings and immediately provides our clinical customers with more options and flexibility for COVID-19 testing. And, as the point-of-care diagnostic market expands globally, we're well-positioned to deliver a broader menu of tests to meet increasing demand," Stevenson continued. 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.

Read More