Rigaku Analytical Devices, the market leader in handheld 1064nm Raman laser technology, is demonstrating its portfolio of analyzers – the Rigaku Progeny ResQ and Rigaku ResQ CQL this week at the International Association of Chiefs of Police (IACP) Conference in Chicago, Illinois in booth #5345.
The IACP Conference is a four-day event offering education and networking opportunities among more than 16,000 public safety professionals.
Based on the combination of an award-winning platform and proven performance, the Rigaku family of Raman solutions offers law enforcement an advanced method for identifying illegal drugs and other potential threats. Users can easily perform chemical analysis of powders, gels, liquids and mixtures through packaging, thus avoiding exposure to potentially hazardous substances – such as fentanyl. By utilizing 1064nm Raman technology, sample-induced fluorescence is eliminated when analyzing colored substances or through colored packaging with identification results in seconds.
In addition, visitors can see a demonstration of Rigaku’s new QuickDetect advanced automated colorimetric solution that provides detection of trace or non-visible amounts to its existing ResQ® CQL handheld Raman analyzer.
The Rigaku series of handheld Raman analyzers are supported by a global sales and support distribution team, offering 24//7 Reachback support, library updates and software upgrades for the life of the analyzer.
The Yersinia genus covers a vast range of bacteria that are distinguished by criteria such as whether or not they are able to cause disease (their pathogenicity). For instance, Yersinia pestis causes plague, while the bacteria Yersinia enterocolitica and Yersinia pseudotuberculosis are responsible for bowel diseases. Researchers at the Institut Pasteur have developed a new genomic analysis method for classifying and identifying all Yersinia strains and estimating their pathogenicity.
The Yersinia genus, part of the family Enterobacteriaceae, currently includes 19 species and three pathogens affecting humans:
the plague pathogen Yersinia pestis;
and the foodborne pathogens Yersinia enterocolitica and Yersinia pseudotuberculosis, which cause enteric yersiniosis, a disease that is transmissible by food.
Yersinia enterocolitica is the third biggest cause of bacterial diarrhea in temperate and cold countries after Salmonella and Campylobacter. In France, infections mostly occur in isolated cases or affect small groups. "Previously, strains were identified using biochemical methods, which sometimes lack precision. They rely on metabolic reactions, leading to misidentification in the event of atypical reactions," says Cyril Savin, Deputy Director of the National Reference Center (CNR) for Plague and other Yersinia Infections, hosted by the Institut Pasteur.
More accurate identification needed
In such circumstances, an identification strategy applicable to all species of Yersinia, including those that have not yet been described, is a useful asset. Scientists in the Institut Pasteur Biodiversity and Epidemiology of Bacterial Pathogens Unit therefore joined forces with the CNR and the Bioinformatics and Biostatistics Hub in the Department of Computational Biology to develop a genome-based method of identifying strains of the Yersinia genus (a genome includes all the genes contained in DNA). "We developed a method for analyzing the genome sequence, enabling it to be translated quickly and comprehensibly," explains Sylvain Brisse, head of the Biodiversity and Epidemiology of Bacterial Pathogens Unit. "When we scanned the sequence of numerous genes in the Yersinia genome for each strain, we realized that each bacterium has its own unique genetic profile. The method involves transforming this genetic profile into a sort of standardized 'barcode'." By applying this method to the Yersinia genus, over 3,000 barcodes were identified, some of which revealed new species. "Our work culminated in a standardized language enabling all labs to recognize these codes," continues Sylvain Brisse. To disseminate the method, public access was provided to a database of "barcodes" (genomic profiles) and associated identification details, enabling labs throughout the world to identify Yersinia strains using their own genomic sequences.
Using an automated classification algorithm, each genomic profile is linked to its species and genetic lineage. "Our comparison of the genetic profiles of Yersinia strains revealed an unexpected level of biodiversity including several new and previously unknown species. Strains can now be identified extremely reliably based on their genomic profile", says Alexis Criscuolo, a bioinformatician in the Department of Computational Biology. "Using this method, we can also more accurately define the pathogenicity of strains sent to us at the CNR. Approximately 33% of them are not pathogenic!" emphasizes Cyril Savin. Accurate identification of strains is, in fact, essential since pathogenicity differs among Yersinia strains: "It enables more effective patient monitoring and can also be used to guide the rollout of public health initiatives," explains Javier Pizarro-Cerdá, head of the Yersinia Research Unit at the Institut Pasteur.
Strain taxonomy – a major challenge within the field of bacterial infection
The analysis of microbial strain diversity plays a key role in addressing infectious diseases. As part of its 2019-2023 Strategic Plan, the Institut Pasteur is seeking to expand its expertise of microbial strain taxonomy (a branch of biology aimed at classifying living organisms into groups known as taxons with a view to identifying them). This genomic taxonomy project is part of a broader program. In order to increase the impact of research on health, the Institut Pasteur is engaged in a project aimed at organizing, better characterizing, and promoting the Institut Pasteur's biological collections in partnership with the National Reference Centers (CNR) and member institutes of the Institut Pasteur International Network. This vision links in with the concept of global health based on the idea that health should be addressed at global level and also that human, animal, and environmental health, which are interdependent and form a whole (concept of "one health") should be addressed jointly. Within this framework, other genomic taxonomy projects have already been successfully completed, enabling monitoring, classification and decoding of strains of other bacteria researched at the Institut Pasteur such as Listeria, Leptospira, Klebsiella, and the rarer Elizabethkingia. Unrestricted sharing of baseline genomic profiles and their associated barcodes will facilitate research on genetic relationships between strains, enabling the detection of outbreaks and improved understanding of how strains are transmitted at global level and between the environment, animals, food, and humans.
Themis Bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI) announced today the first administration to healthy volunteers in a Phase 1 clinical trial wth Themis’ vaccine candidate against Lassa fever. The MV-LASV Lassa fever vaccine candidate, is based on Themis’ proprietary measles vector platform and exclusively-licensed discoveries made at Institut Pasteur. The MV-LASV Lassa fever vaccine program is funded through a global partnership with CEPI that will support the candidate vaccine’s development up to the end of Phase 2, which is designed to provide clinical safety and immunological data. The investment, which was the first in CEPI’s portfolio, will also help establish investigational stockpiles of Themis’ vaccine candidate that will be ready for clinical efficacy trial testing during outbreaks.
“Themis’ versatile technology platform and our ability to rapidly advance candidates into the clinic has been demonstrated previously through the discovery, development and production of a Phase 3-ready vaccine candidate against Chikungunya as well as our recently announced trial for a novel Zika vaccine,” commented Erich Tauber, MD, CEO of Themis. “Our partnership with CEPI for Lassa fever further validates our capabilities and represents our combined commitment to tackle diseases that remain a public health threat globally.”
Dr. Melanie Saville, Director of Vaccine Development at CEPI added: “Themis was the first company CEPI partnered with to develop a vaccine against Lassa fever and MERS, two of our priority pathogens. Lassa fever remains a serious public health threat across West Africa, with Nigeria alone experiencing its largest ever outbreak of the disease this year1. This first in-human trial for Themis’ MV-LASV Lassa candidate is an important first step in its evaluation in the clinic and toward developing an effective vaccine which will be available to at-risk populations during outbreaks of this deadly emerging infectious disease.”
The MV-LASV vaccine candidate is a recombinant, live attenuated, viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection. The Phase 1 trial with MV-LASV is a randomized, placebo-controlled, dose-finding study in 60 healthy adult participants to investigate the safety, tolerability and immunogenicity of MV-LASV after administration of two different dose levels. The study, sponsored and led by Themis, is being conducted by the Centre for the Evaluation of Vaccination in Antwerp, Belgium, under the direction of Pierre Van Damme, MD, PhD, Professor at the University of Antwerp, Faculty of Medicine and Health Sciences. More information about the trial can be obtained using the ClinicalTrials.gov Identifier, NCT04055454.
Dr Arnab Basu, chief executive at Kromek Group, picked up the Innovation accolade at the national final of the Institute of Directors’ (IoD) Director of the Year Awards. His triumph follows success in the same category at the IoD’s Yorkshire and North East heat earlier this year.
Dr Basu has overseen the continued growth of Durham University spin-out Kromek, which is known for supplying radiation detection technology for the medical, security screening and nuclear markets. Its D3S family of products is particularly regarded for identifying terrorist threats.
Praising Dr Basu, who is a council member of Innovate UK, judges said “there is an undeniably strong link between this director’s leadership and the development of the organisation as a highly innovative one.”
The world’s lightest and smallest gas analyzer GT5000 Terra (9.4 kg with battery) knows what’s in the air. The user-friendly analyzer can be operated wirelessly for measuring up to 50 gases simultaneously in a matter of seconds. The analyzer is capable of identifying a total of more than 300 gases.
GT5000 Terra is a gas analyzer designed for field use. It utilizes cutting-edge FTIR technology which allows the analyzer to identify and measure airborne gases easily and reliably even in the most demanding conditions. The analyzer has an innovative highly integrated optical structure: the number of moving parts has been minimized to maximize the stability. As GT5000 Terra is IP54 rated, it is suitable for versatile, carefree outdoor use in any weather – even in subfreezing temperatures.
The compact and durable multigas analyzer can be used for measuring both natural and harmful airborne gases in numerous applications. Toxic gases can be easily identified with GT5000 Terra for example in containers, laboratories, production facilities and accident sites. In addition, the analyzer is excellent for measuring natural greenhouse emissions in outdoor environments. The device is equipped with an integrated pump and an internal battery. It can be equipped with optional accessories according to the application or client’s needs.
“As a response to users’ wishes, we reduced the gas analyzer’s size to a minimum and invested in user-friendliness without compromising performance. The analyzer’s wireless functions are particularly useful in hazardous or uncomfortable conditions as the analyzer can be controlled remotely from a safe distance,” explains Anna Leino, Product Engineer at Gasmet.
Intuitive user interface for measuring over 300 gases
GT5000 Terra is easy to setup and the measurement is initiated with the press of a single button. The updated, intuitive Calcmet Easy software can be run by a tablet, enabling easier interpretation of results on site. Both the device and the software have been designed to be used by anyone, with minimal training. The tablet’s touch screen can be used even when wearing protective gloves.
“The software guides the user in making analyses and warns if the sample contains too high concentrations of, for example, hazardous gases or if the sample contains unknown components,” Leino states.
The Calcmet Expert is the choice when identification of unknown compounds or deeper analysis of the results is required. The Calcmet Expert software provides additional tools for more thorough analysis of measurement results. Calcmet Expert provides access to Gasmet’s list of over 300 gases, enabling the identification of unknown gases in the sample.
Key features of GT5000 Terra
The world’s lightest and smallest portable multigas analyzer (9.4 kg with battery)
Weather-proof, IP54 rated
Measures up to 50 gases simultaneously using the FTIR technology (Fourier Transform Infrared Spectroscopy) Capable of measuring over 300 gases
Dimensions: 450 x 287 x 166 mm (17.7 x 11.3 x 6.5 inches)
Integrated pump and battery
Operating temperature: –5…40°C (23…104°F)
Intuitive Calcmet Easy user interface for field operation and more versatile Calcmet Expert for further analyses at the office
Can be operated remotely: Wifi station, Wifi Access point, Bluetooth, Ethernet, HID (USB)
SwabTek, leaders in the narcotics and explosives presumptive testing industry, will introduce the world's ONLY DRY reagent narcotics and explosives field test kits developed for the law enforcement community (federal, state and local as well as School Resource Officers and the aviation industry) at the 2019 IACP (International Association of Chiefs of Police) Conference and Exposition in Chicago, IL, October 26–29. In attendance will be members of the company's advisory board, including Tom Ridge, the former Governor of Pennsylvania and first U.S. Secretary of Homeland Security.
Meeting some of the most daunting challenges facing society today head on, including the current alarming opioid and vaping crises, SwabTek will present the brand's soon-to-be-released products that are poised to help solve those issues. Among SwabTek's innovative solutions: Presumptive testing kits for the detection of Fentanyl to curb overdoses; detection of Nicotine and other harmful substances in vaping pens to protect children and adults who vape; and a test to discern between THC and Hemp, specifically developed in response to requests from federal, state and local agencies, including the DEA.
Currently-shipping SwabTek products include test kits for the detection of Marijuana, Amphetamines, Cocaine and Heroin, and test kits for the detection of dry and liquid explosives. These products are already in use by multiple law enforcement agencies, schools and airports worldwide.
On his role as a SwabTek advisory board member, Governor Ridge stated, "It is gratifying to be part of a company that will have a profound impact on our nation's security, while also specifically protecting schools and our communities."
CEO Bobby Betros will be on hand at the IACP Conference and Exposition to do live demos of the SwabTek Marijuana Test Kit, specifically designed for detection on surfaces and in substances, including vaping pens and edibles. As sponsors of the Conference, SwabTek is providing 2 of the Marijuana Test Kits in each attendee bag distributed to Conference attendees.
With its disruptive, patent-protected technologies implementing a single-use spot test utilizing a paper strip with dry reagent test zones applied to the strip surface, and a cotton swab to transfer the suspect residue to the paper strip test zone with minimal disruption, SwabTek test kits provide a safe, 100% recyclable, non-hazardous alternative to the old industry standard of complicated, multi-step test sequences. By basing its products on dry powdered reagents, the brand has done away with bulky and hazardous liquid reagent dropper bottles, breakable ampoules and pressurized spray cans, and does not require any special neutralizers or disposal procedures.
"The launch of the SwabTek brand comes at a very exciting time for presumptive field testing, an industry that has been stagnant for more than 30 years now," says Betros. "Over the past decades, law enforcement professionals have found themselves underequipped as traditional presumptive field tests have fallen out of use due to concerns over officer safety and reliability."
"Now, SwabTek's safe, easy, and intuitive form factor puts field test kits safely back in the hands of officers, and into new spaces such as classrooms and homes where, due to the toxic and dangerous kits of incumbents, field testing has never been possible before. The company is also aggressively working on products tailored to serve other markets, targeting public health and safety and consumers, including concerned parents and caregivers."
See how SwabTek's safe, one-step presumptive field test kits deliver results in seconds HERE.
Conference attendees will find the SwabTek team at Booth #1336. For more information on SwabTek and how to obtain products, visit www.swabtek.com.
GlaxoSmithKline plc has announced the divestment of travel vaccines Rabipur (tradename Rabavert in the US) for the prevention of rabies, and Encepur for the prevention of tick-borne encephalitis, to Bavarian Nordic.
The decision to divest these brands, acquired from Novartis in 2015 as part of the acquisition of its vaccines business, supports GSK’s strategic intent to increase focus and reinvest in growth assets, innovation and a simplified supply chain in its vaccines business.
Roger Connor, President, Global Vaccines at GSK, said: “This agreement with Bavarian Nordic will enable us to commit greater resources to our key growth assets and to our R&D pipeline, while also ensuring the continued supply of these important and successful vaccines.”
GSK will receive an upfront payment of approximately EUR301 million (£259m) and will also receive milestone payments of EUR495 million and additional proceeds from the sale of inventory over the course of the supply arrangements for a total consideration of up to EUR 955m. The value of inventory at the anticipated closing date is estimated to be EUR 159 million. EUR 25m (£22m) of the total consideration is conditional upon future sales performance of the two vaccines. Milestones are payable upon successful technology transfer, marketing authorisation transfers and the fulfilment of GSK’s supply commitments until Bavarian Nordic obtains regulatory approval to manufacture the vaccines.
To ensure supply continuity both vaccines will continue to be manufactured primarily at GSK’s Marburg site in Germany until full production is transferred to Bavarian Nordic. The staged technology transfer is expected to commence in Q1 2020 with completion anticipated within 5 years.
No employees or manufacturing facilities are being transferred as part of this transaction. The transaction is expected to close by the end of 2019 and is conditional upon anti-trust approval as well as approval of Bavarian Nordic’s rights issue by its shareholders.
About Rabipur (Tradename Rabavert in US and Canada)
Rabipur is a well-established life-saving vaccine (rabies virus causes acute invariable fatal disease) with 30 years of market experience supported by extensive clinical and safety evidence and WHO pre-qualification. It is indicated both in persons bitten by suspect animals (PEP[1]) and non-immune subjects at risk of rabies (PrEP[2]).
About Encepur
Encepur is indicated for active immunization of high-risk populations against tick-borne encephalitis (TBE). It has unique dosing flexibility supported by proven efficacy and long-term persistence data.
Cincinnati Reds Begin Installation of Multi-Sensor Threat Detection Platform
Patriot One Technologies Inc.developer of the PATSCAN™ Multi-Sensor Covert Threat Detection Platform, is pleased to announce the sale of its PATSCAN Multi-Sensor Covert Threat Detection Platform with its security system to integrator/reseller partner Ginter Electrical Contractors, LLC (“Ginter Electrical”) of Cincinnati, OH and Major League Baseball franchise, the Cincinnati Reds.
“We’re extremely excited to be deploying our PATSCAN Platform with Ginter Electrical and the Cincinnati Reds, Major League Baseball’s first professional team,” said Martin Cronin, Patriot One CEO. “Working with our reseller Ginter and the Reds’ security team has been a fantastic experience. Both organizations are focused on creating a safe venue without making it feel like a fortress so fans can enjoy the game of baseball.”
The PATSCAN Multi-Sensor Covert Threat Detection Platform was shipped this week to Ginter Electrical in Cincinnati, Ohio, where they will be joined by Patriot One engineers and the Cincinnati Reds security teams to begin deploying the solution. Specific location of the Platform’s deployment will not be disclosed.
“Both the Cincinnati Reds security team and our security specialists and engineers at Ginter Electrical were impressed with the PATSCAN Platform,” shared T.J. Dooley, Ginter Electrical’s Systems Integration Manager. “This is the type of covert threat detection solution our team and clients have been looking for to ensure the safety of their entire organizations, from staff to vendors to clients. It’s exciting to begin deploying the solution with the Reds organization - one of the most recognized and celebrated sport franchises in the US.”
“We pride ourselves in providing a safe environment for our fans and employees. A covert threat detection solution like Patriot One’s PATSCAN Platform offers us the opportunity to detect threats early enough to prevent any issues,” explained Cincinnati Reds’ Director of Public Safety, John Cordova. “Major League Baseball games are fun and entertaining. Our entire organization is focused to keep it that way today and for years to come.”
Following the initial deployment of the PATSCAN Platform at a Cincinnati Reds undisclosed location, Patriot One and Ginter Electrical will work to broaden deployment of the solution within the Reds organization, as well as with other Ginter Electrical clients who have expressed interest in the multi-sensor threat solution because of its covert deployment capabilities.
Porton Biopharma Ltd (PBL) has today announced that it has signed a modification to its contract (HHSN272201600045C) with the US National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to advance a next generation intra-nasal anthrax vaccine into the clinical-trial phase. The contract modification is worth US $4.5 million and follows approval by the US Food and Drug Administration (FDA) of the investigational new drug (IND) application.
PBL is working with US clinical-stage company Blue Willow (Ann Arbor Michigan) who will be responsible for the execution of the clinical study. The phase 1 clinical study is expected to begin enrolment this year and combines Blue Willow’s novel intra-nasal NanoVax® system with PBL’s recombinant protective antigen for anthrax. The combination of technologies produces a more effective product than currently licensed vaccines by enabling immunity to be achieved in fewer doses and via intra-nasal delivery, instead of injection
PBL’s contract supports the advanced development of candidate vaccine components and technologies that accelerate the immune responses for use in post-event settings following the intentional release of the Category A priority pathogen Bacillus anthracis, the bacterium that causes the disease anthrax, or in response to naturally occurring outbreaks of the disease.
The total costs of the work being performed under contract HHSN272201600045C is 100 percent financed by NIAID. The total value of the contract could be worth up to US $24million over its 8-year term, if all options are exercised.
Commenting on the award, Dr Roger Hinton Managing Director of PBL said “We are delighted that we are able to progress into the clinical phase of the contract and this latest award is a recognition of all the hard work of staff at PBL and its partner Blue Willow, especially in writing, reviewing and gaining approval for the IND from the FDA.
This is a pivotal study that builds on the research and development that has been used to progress this novel product to date by PBL and its partners in collaboration with NIAID’s technical team. It is a recognition of the knowledge and expertise within the company and demonstrates the ability of PBL to further deliver on our track record of developing and manufacturing life-saving products for world-wide markets.”
FLIR Systems, Inc. today announced the launch of the FLIR identiFINDER R425, the next-generation of its field-trusted R400 handheld radionuclide identification device (RID). The identiFINDER R425 provides responders with increased sensitivity, flexible power management, and advanced communication features that enable them to safely locate and measure radioactive sources with confidence.
A new single cubic detector design, sourceless stabilization, advanced heuristics, and hybrid identification techniques enable the FLIR identiFINDER R425 to deliver high-performance detection in all directions. It delivers three times the gamma and two times the neutron sensitivity of currently-fielded systems, so responders can detect radiological threats from farther away and behind heavier shielding. Where other systems can become inoperable in extremely high gamma fields, the identiFINDER R425 remains fully operational, delivering pinpoint accuracy.
“Our next-generation R425 means better detection in all directions and builds on the R400’s successful legacy of identifying and measuring radioactive sources with precision,” said Dennis Barket, Jr., vice president and general manager of FLIR Systems’ Detection division. “With more than 25,000 devices deployed, responders trust the accuracy and reliability of FLIR identiFINDER, and the R425 will be a powerful tool for military, homeland security, public safety agencies, and commercial entities around the world that watch over this vital mission area.”
At 15% lighter weight than the previous generation RID, the identiFINDER R425 provides ergonomic balance for a variety of scenarios, including surveying, emergency response, and environmental monitoring. The internal battery delivers 12 hours of use, with power options that include disposable or rechargeable batteries that can be hot-swapped for up to four more hours of extended operations. The system boasts an IP67-rating and features a fully enclosed solid-state detector to withstand harsh environments.
When threat detection occurs, rapidly communicating results is critical. Remote data viewing, operation, and reach-back is made possible on the R425 through communication features including dual USB-C ports, the FLIR web interface and RAD Mobile App, and a universal API that enables integration with user deployed networks such as the Mobile Field Kit, ATAC, Sigma Edge, and Safe Environment Gateway. The identiFINDER R425 also has built-in Bluetooth and GPS technology. The single-hand operation via three-button control is a familiar interface for existing identiFINDER users, simplifying deployment and training requirements.
FLIR will unveil the FLIR identiFINDER R425 at the IACP Annual Conference and Exposition, October 26-29 in Chicago, Illinois and at the IEEE Nuclear Science Symposium, October 26-November 2 in Manchester, United Kingdom. The FLIR identiFINDER R425 is available for order now and will begin shipping by the end of 2019. To learn more about the product, visit:http://www.flir.com/r425
Researchers from the Center for Applied NanoBioscience and Medicine (ANBM), The University of Arizona, College of Medicine have developed a lood self-collection device to quickly estimate a person’s exposure to radiation in the event of a nuclear accident or attack.
The Led by Jian Gu, PhD the study reports development of a system for packaging critical components of a traditional blood-collection kit to create an integrated fingerstick blood collector for radiation countermeasures. An easy-to-use, self-administered blood test that quickly could evaluate a person's radiation exposure would help triage emergency medical treatment in the event of a radiological or nuclear event. The U.S. Department of Health and Human Services long has sought ways to monitor a population's radiation exposure following such an event.
Using 3-D printing, a miniaturized vacuum tube, coupled with integrated capillaries and a lancet, were fabricated into a self-collection device that can process the blood specimen for both cytogenetic and gene expression biodosimetry that then would be analyzed in a centralized bioanalytical laboratory. Cytogenetic biodosimetry measures the response of circulating blood lymphocytes in the body to accurately estimate the absorbed radiation dose. Gene expression biodosimetry measures the expression levels of a panel of radiation-sensitive genes for the absorbed dose. Results could be returned in one day in the gene expression tests and three days with the cytogenic tests.
"The integrated collector will alleviate the sample collection bottleneck for radiation countermeasures following a large-scale nuclear event, and may be useful in other applications with its self-collection and liquid reagent sample preprocessing capabilities," Dr. Gu said. The study is part of a core National Institutes of Health program, led since 2005 by Frederic Zenhausern, PhD, MBA, ANBM center director, in partnership with Columbia University and Georgetown University, under a U19 National Institute of Allergy and Infectious Diseases grant, sponsored by the Center for Medical Countermeasures Against Radiation. Teams at the UA College of Medicine - Phoenix and Columbia University have co-developed three major assay platforms for high-throughput biodosimetry, including gene expression, cytogenetics (a branch of genetics concerned with how chromosomes relate to cell behavior during mitosis and meiosis) and metabolomics (the study of small molecules, or metabolites within cells, blood or tissues).
The full research article is availble to read here
Jamaah Ansharut Daulah, or JAD, an Islamic State-affiliated terror group based in Indonesia, has been making bombs using not only high-explosive materials but also poisonous ingredients, according to police statements follwing a series of arrests of the group's members.
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on Thursday allowed the marketing of the first rapid diagnostic test for the Ebola virus that has not been authorized via the agency’s Emergency Use Authorization (EUA) pathway.
OraSure Technologies’ OraQuick Ebola Rapid Antigen Test, which provides a rapid, presumptive diagnosis that must be confirmed, gained market entry via CDRH's De Novo review pathway less than five months after its request for classification was submitted (FDA's De Novo performance goal review time is 150 days). The test was also granted a Breakthrough device designation.
“This marketing authorization may provide additional assurances to health care professionals seeking to use these types of rapid diagnostics. The ability to use this test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients and begin treatments that can be potentially life-saving,” acting FDA Commissioner Ned Sharpless said.
The Ebola outbreaks in the Democratic Republic of Congo and in West Africa dating back to 2014 have killed more than 11,000.
Previously, FDA worked quickly with the CDC and test developers to make diagnostic tests, including the OraQuick Ebola Test, available via the EUA pathway to address this public health emergency.
“For the OraQuick Ebola Test submission, the FDA reviewed data from multiple clinical studies of blood samples and cadaveric oral fluid from the 2014 West African outbreak and from a variety of analytical studies. Based on these data, the FDA determined that general and special controls were necessary to provide a reasonable assurance of the safety and effectiveness of the OraQuick Ebola Test when intended to identify antigens associated with Ebola virus in blood from symptomatic patients and oral fluid of cadavers,” FDA said.
And the agency notes that the test is not intended for general Ebola infection screening (e.g., airport screening) or the testing of individuals at risk of exposure without observable signs of infection.
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