Monday, April 22, 2019

Early Detection of Viruses in Biopharma

Researchers in Carnegie Mellon University’s Department of Chemical Engineering (ChemE) are collaborating with leading biotechnology company Genentech, a member of the Roche Group, and LumaCyte, a biotechnology instrumentation company based in Charlottesville, VA, to develop an advanced biomanufacturing technology for adventitious agent testing, or testing for unexpected viral infections during the production of biopharmaceuticals.

The research recently received funding from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to develop and test technologies for improving the safety testing of biologic medicines during production and prior to release. This project, which aims to rapidly and accurately detect viral infectivity in biopharmaceuticals, was one of the first four proposals funded by NIIMBL. The team, which includes Carnegie Mellon, Genentech, and LumaCyte, will receive $1.5 million in funding from NIIMBL over 18 months.

When using biological materials such as mammalian cell lines to produce pharmaceuticals, manufacturers face the risk of viruses infecting the batch. Currently, testing for adventitious agents such as viruses happens late in the manufacturing process—but the research team, which includes ChemE Professor Jim Schneider and Adjunct Professor Todd Przybycien, are developing technologies to test biopharmaceutical batches while they are being produced.

“If you don’t find out about infection until very late in the process, you will have wasted a lot of time and money as more downstream equipment and product becomes infected,” says Schneider. “Current infection detection techniques, such as cell-based assays and polymerase chain reaction, can take days to complete. Our methods can provide readout in less than 15 minutes, which enables a routine, continuous type of testing that could detect infections almost as soon as they take hold.”

Rapid DNA analysis has been in development for a number of years by Schneider and Przybycien, who is also a professor of chemical and biological engineering at Rensselaer Polytechnic Institute. Using a rapid DNA analysis technique developed in Schneider’s lab, the team is detecting viruses and bacteria in process streams used to make biologic pharmaceutical projects. By performing rapid electrophoresis, the researchers can separate tagged and untagged DNA in a sample, indicating the presence of virus or bacteria in biologic process streams.

The researchers aim to combine their method with LumaCyte’s LFC and Radiance technology for a faster, more reliable, and more cost-effective solution. LumaCyte’s Radiance and Carnegie Mellon’s patented rapid DNA analysis platform will combine to rapidly detect the presence of virus and/or bacteria in bio process streams.

“The focus of NIIMBL is to translate existing technologies into biomanufacturing contexts,” said Schneider. “One of the top priorities that the industry has identified is rapid adventitious agent screening. As one of the first four projects funded by NIIMBL, this research with LumaCyte and Genentech shows our commitment to collaboration between academia and the pharmaceutical industry."

NIIMBL is an Innovation Institute designed to revolutionize domestic biopharmaceutical manufacturing. Funded through a $70 million cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce, NIIMBL funds and collaborates on innovative manufacturing technologies that bring life-saving and life-enhancing products to market faster and at reduced cost, while maintaining safety and efficacy.

LumaCyte is an analytical instrument development company headquartered in Charlottesville, VA. LumaCyte produces a label-free cell analysis and sorting instrument called Radiance that does not require the use of antibody or genetic labelling for analysis of cells. Applications of LumaCyte’s label-free platform technology include viral infectivity for vaccine manufacturing, cell and gene therapy, cancer biology, infectious disease, and pre-clinical drug discovery.

Tuesday, April 9, 2019

New Diagnostics to be Highlighted at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam

A number of companies will be highlighting their new technologies at the 29th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). ECCMID is being held on April 13 – 16, 2019 in Amsterdam, Netherlands. Below you will find prep releases from some of these companies.

Mesa Biotech to Introduce Expanded Molecular POC Testing Portfolio at the European Congress of Clinical Microbiology and Infectious Diseases

Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced it will demonstrate its expanded, novel Accula™ Test System at the 29th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). ECCMID is being held on April 13 – 16, 2019 in Amsterdam, Netherlands and the Accula System will be on exhibit in Booth 1.1C. Mesa Biotech has obtained CE Mark in the European Union (EU), as well as 501(k) clearance and CLIA Waiver from the U.S. Food and Drug Administration (FDA) on both its Accula Flu A/Flu B and RSV tests.

The Accula System, recently named 2019 Frost & Sullivan Price/Performance Global Value Leader, is a palm-sized, reusable dock with disposable test cassettes. The novel molecular test system offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes to guide same day treatment decisions. Both the Accula Flu A/Flu B and RSV tests are indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

"We are excited to introduce our expanded PCR test platform at ECCMID," said Hong Cai, Co-founder and Chief Executive Officer, Mesa Biotech, Inc. "As our product offerings continue to increase, we are carefully selecting additional strategic distributors to add to our growing international network."

About Mesa Biotech Inc.

Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ System consists of a portable, palm-sized dock and disposable, assay-specific test cassettes. This patented system enables healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA). Both products are distributed in the US by Sekisui Diagnostics under the Silaris™ brand. Mesa Biotech has also secured a number of strategic agreements for distribution in Europe and Asia.

T2 Biosystems and Clinicians to Share Clinical Data in Integrated Symposium and Poster Presentations at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID)

T2 Biosystems, Inc., an emerging leader in the development of innovative medical diagnostic products for critical unmet needs in healthcare, announced today that the Company will host an integrated symposium highlighting key clinical data about the T2Bacteria® and T2Candida® panels at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam on Monday, April 15, at 16:00-18:00 Central European Time (CET). ECCMID will take place April 13-16 at the Amsterdam RAI Exhibition and Convention Center.

Additionally, seven leading clinicians and users of T2Direct Diagnostics™ will offer scientific presentations during ECCMID that will highlight the most recent scientific data on the Company’s FDA-cleared T2Bacteria and T2Candida Panels. The Company will also present the first patient case studies with the T2Resistance™ Panel, which recently received FDA Breakthrough designation and is pending CE mark for commercial availability in Europe. All presentations will demonstrate the potential for these panels to significantly improve infectious disease management for patients in real clinical settings.

“I have seen firsthand how the rapid detection of bacterial and fungal pathogens with T2Direct Diagnostics can improve patient outcomes, better manage broad-spectrum antimicrobial usage and combat antibiotic resistance,” said Neil Clancy, MD, University of Pittsburgh Medical Center, who is one of the integrated symposium speakers.

The T2Bacteria and T2Candida Panels are able to identify sepsis-causing pathogens within 3 to 5 hours directly from whole blood, instead of days required with blood culture based diagnostics. This gives clinicians actionable information much earlier than was previously possible, allowing them to make more informed treatment plans for escalation or de-escalation of antimicrobial therapy.

Dr. Clancy continued, “When diagnosing and treating infectious diseases, time is of the essence. I am proud to be one of the clinicians here at ECCMID using T2Direct Diagnostics and believe that we must continue to spread awareness about this rapid diagnostic technology to improve patient care.”

T2 Biosystems will showcase its latest innovations at Booth #1.22. The Company will also host an educational event, “Rapid Diagnostics Direct from Whole Blood: A Solution for Fast and Appropriate Antimicrobial therapy,” which will be co-chaired by Prof. Karsten Becker, MD, University Hospital Münster and Prof. Emmanuel Roilides, MD Aristotle University of Thessaloniki; and it will include the following presentations:

Integrated Symposium

-- “Rapid Diagnostics Direct from Whole Blood: A Solution for Fast and Appropriate Antimicrobial Therapy,” on Monday, April 15 from 16:00-18:00 CET in Hall D; presenters include: • Prof. Michael Bauer, MD, Jena University (Jena, Germany) • Dr. Cornelius (Neil) Clancy, University of Pittsburgh Medical Center (Pittsburgh, PA) • Dr. Giulia De Angelis, Institute of Microbiology, UniversitàCattolica del Sacro Cuore, Fondazione Policlinico Universitario Agostino Gemelli (Rome, Italy) • Dr. Thomas Walsh, New York Presbyterian Hospital (New York, NY)

Poster Presentations

-- Development of a highly sensitive assay for the detection of carbapenem-resistance genes from whole blood by T2 magnetic resonance, on Sunday, April 14, from 13:30-14:30 CET (Tom Lowery) -- Real-life diagnostic performance of T2Candida among ICU patients with risk factors for invasive candidiasis, on Tuesday, April 16 from 12:30-13:30 CET (Maiken Arendrup) -- The T2Bacteria assay is a sensitive and rapid detector of bacteraemia that can be initiated in the emergency department and has potential to favourably influence subsequent therapy, on Tuesday, April 16 from 12:30-13:30 CET (Christopher Voigt) -- The T2Bacteria Panel is a rapid detector of bacteraemia and has potential to guide therapy in patients with haematological malignancies and haematopoietic stem cell transplantation: a pilot study of non-culture molecular diagnosis, on Tuesday, April 16 from 12:30-13:30 CET (Thomas J. Walsh) -- Evaluation of a molecular technology magnetic resonance for the direct identification of pathogens from blood samples in paediatric patients with suspected sepsis, on Tuesday, April 16 from 12:30-13:30 CET (Paola Bernaschi)

About T2 Biosystems

T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease.

Sunday, March 31, 2019

Sherlock Biosciences Launches to Provide Better, Faster and More Affordable Diagnostic Testing Worldwide Through Engineering Biology

Sherlock Biosciences, an Engineering Biology company dedicated to making diagnostic testing better, faster and more affordable, announced its launch and initial financing of $35 million. The financing includes a $17.5 million non-dilutive grant and an investment from the Open Philanthropy Project with support from additional undisclosed investors.

Sherlock is using Engineering Biology tools, including CRISPR and Synthetic Biology, to create a new generation of molecular diagnostics that can rapidly deliver accurate and inexpensive results for a vast range of needs in virtually any setting.

“Our founders have created some of the most important breakthroughs in modern science through advances in the field of Engineering Biology, the practice of designing and building biological systems into tools that can enhance human health,” said Rahul K. Dhanda, Sherlock’s co-founder, president and CEO. “We are building Sherlock to transform these breakthroughs into a new and powerful generation of molecular diagnostics that will enable users to make more effective decisions in both clinical and non-clinical settings worldwide – including hospitals, industrial settings, low-resource settings and at home.”

The company takes its name from one of its foundational platform technologies, SHERLOCK™ (Specific High-sensitivity Enzymatic Reporter unLOCKing), which is licensed from the Broad Institute of MIT and Harvard. SHERLOCK was developed by a team led by co-founder and chair of Sherlock’s scientific advisory board Feng Zhang, Ph.D., and collaborators, as a method for identifying specific genetic targets using CRISPR. SHERLOCK can detect genetic fingerprints across multiple organisms or sample types and has been described in four papers published in the journal Science.

The company is also developing INSPECTR™ (INternal Splint-Pairing Expression Cassette Translation Reaction), a Synthetic Biology-based molecular diagnostics platform developed by a team led by co-founder James J. Collins, Ph.D., at the Wyss Institute for Biologically Inspired Engineering at Harvard University. The technology, licensed from Harvard’s Office of Technology Development, can be programmed to distinguish targets based on a single nucleotide without an instrument, at room temperature.

Used as stand-alone tools or in combination, these platforms allow for the detection and quantification of targets without complex instruments and in a variety of potential settings. The flexibility and modularity of these platform technologies open a wide range of potential applications and actionable insights in areas including precision oncology, infection identification, food safety, at-home testing, and disease detection in the field.

The company will employ a strategy of selective partnering and direct product development to apply these technologies into a wide range of settings and applications. The financing will be used to advance development programs and design new assays.

“Engineering Biology-based tools have broad potential to transform not just the treatment of disease but also how diseases are diagnosed,” said co-founder James Collins, Ph.D. “Sherlock Biosciences will make a significant difference in the world by bringing the power of Synthetic Biology and CRISPR to diagnostic development.”

“We believe Sherlock Biosciences offers an enormous opportunity to improve human health worldwide by delivering fast, accurate and simple diagnostic testing. It is especially encouraging that the broad potential of its technologies is matched by co-founders and a team who are deeply experienced scientists, entrepreneurs and clinicians,” said Heather Youngs, program officer for scientific research at the Open Philanthropy Project. “Development of this technology could both reduce viral pandemic threats and benefit healthcare more broadly. We are excited to support Sherlock’s efforts to realize the potential of diagnostics and propel this technology into the mainstream.”

“Our team has the expertise and technology to transform diagnostics with a powerful set of Engineering Biology tools to enable rapid test design and deployment, an essential component of addressing many healthcare needs, including the growing problem of resistant bacteria,” said co-founder Deborah Hung, M.D., Ph.D. “After early experiments, our tools were quickly used in a wide range of geographies with real patient samples, confirming that we can swiftly respond to urgent healthcare needs.”

“We founded Sherlock Biosciences to improve health worldwide through the development of disruptive molecular diagnostics. We are delighted to have the support of the Open Philanthropy Project and our investors as we develop Sherlock’s platforms to achieve that goal,” said co-founder David Walt, Ph.D. “Existing molecular diagnostic tools are often limited in their effectiveness because they are costly, labor-intensive, and are not mobile. We believe that Sherlock is poised to overcome those challenges by creating tests that are faster, less expensive and easier to use than currently available molecular diagnostics.”

Saturday, March 2, 2019

FDA, CDC, and CMS Launch Task Force to Facilitate Rapid Availability of Diagnostic Tests During Public Health Emergencies

The U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.

“Public health emergencies, like Ebola outbreaks, remind us that we’re a global community when it comes to public health protection. Bacteria and viruses don’t respect territorial boundaries. It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. We’re all in this together. To that end, the FDA knows that collaborating with our federal partners to employ our collective expertise, experiences from previous incidents, and resources will better assist in a global response. We also believe that this task force could lead to more innovation for diagnostic tests as developers will see a more predictable federal regulatory response through the agencies’ coordination,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “This task force will help our agencies better collaborate to prepare for, and respond to, public health threats, including identifying threats and ensuring the appropriate diagnostics are in place to support efforts in the field.”

The FDA, CDC and CMS each play a critical role in responding to public health emergencies, including identifying threats, regulating medical products, and providing oversight for laboratories. The agencies have robust teams of scientists, researchers and policy experts that are dedicated to preparing the U.S. for rapid disaster response.

Diagnostic tests—such as those that can detect pathogens like the Ebola and Zika viruses—can be quickly made available to meet response needs during a crisis through the Emergency Use Authorization (EUA) process. The FDA has authority to issue an EUA for the use of diagnostic tests during public health emergencies, provided criteria are met. The CDC is responsible for providing agent-specific subject matter expertise in epidemiology, laboratory expertise and guidance to clinicians and laboratories responding to the emergency. The CDC and other federal laboratories are often the ones developing new tests to respond to emergency needs. CMS has authority to ensure quality testing at laboratories through the Clinical Laboratory Improvement Amendments (CLIA). CMS provides guidance, even during public health emergencies, to laboratories on meeting CLIA requirements to ensure laboratories produce accurate, reliable and timely results.

Prior to this partnership, feedback from the clinical laboratory community indicated that there was uncertainty about how to implement the diagnostic tests once they received an EUA; particularly, the community was uncertain about meeting CLIA regulations under an EUA to allow labs to start testing specimens.

“During public health emergencies, ensuring the health and safety of patients through quality laboratory testing will remain the focus of CMS,” said Kate Goodrich, director of the Center for Clinical Standards and Quality and CMS Chief Medical Officer. “Timely implementation of EUA diagnostic assays in the US healthcare system is dependent upon laboratories understanding the instructions for use and applying them to the patient samples received for testing. As part of this taskforce, it is our goal to provide clear and consistent guidance to laboratories on the application of CLIA requirements for these emergency assays.”

By standardizing collaboration efforts, the federal partners hope to address issues related to implementation of diagnostic tests authorized for emergency use under an EUA, as well as other unmet needs and gaps in preparing and responding to global health threats. The task force will provide a forum for each agency to coordinate, provide consultation, and improve the availability of diagnostic tests during public health emergencies. In addition, to assist in public health preparedness, the task force will work to define, refine and streamline interagency approaches for the implementation of EUA diagnostic tests. The hope is that the task force will enable an even more efficient federal government response for making diagnostic tests available in the event of a public health emergency.

“Time and time again, we’re reminded that disease knows no borders. While our globalized world and modern transportation help promote economic prosperity, these features also facilitate the spread of emerging infectious diseases,” said Chesley Richards, CDC’s Deputy Director for Public Health Science and Surveillance. “In the past 15 years alone, we’ve faced serious global outbreaks of deadly pathogens. During public health emergencies, it is critical for diagnostic tests to be made available and adopted quickly into clinical and public health laboratories for rapid patient care.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.