Tuesday, February 21, 2017
The company's GenoAmp Real-Time PCR Leptospirosis is a multiplex PCR kit that detects pathogenic Leptospirosis in human and environmental samples. It is designed for the fast and early screening of Leptospirosis using a single reaction.
"The kit is intended for rapid and early diagnosis in clinical samples such as blood and urine, as well as for use in environmental surveillance," said the company in a statement. "The kit can be used to test for the disease within the first 3-7 days after initial symptoms, which offers a huge advantage over some of the tests currently available, which can only detect the disease after 7 days." Early detection is critical for better treatment outcome, before the progression of the disease.
GenoAmp Real-Time PCR Leptospirosis detects most of the recommended serovars by WHO, namely Canicola, Pomona, Australis, Bataviae, Pyrogenes, Tarrasovi, Icterohemorrhagiae, Hebdomadis, Ballum, Autumnalis and Javanica and additional tropical serovars like Copenhageni, Hardjo Pratjino, Celledoni & Djasmiman that are commonly found in tropical countries.
Leptospirosis is transmitted by the urine of an infected animal and is contagious as long as the urine is still moist. Leptospiral infection in humans causes a range of symptoms with some infected persons showing no symptoms at all. The disease begins suddenly with fever accompanied by chills, intense headache, muscle ache, abdominal pain, red eye, and occasionally a skin rash. There are two phases to the disease. The first symptoms appear after a period of incubation of 7-12 days. The first phase (acute or septic phase) ends after 3-7 days of illness. The disappearance of symptoms coincides with the appearance of antibodies against Leptospira in the bloodstream.
In 2016, Florida saw 1,272 cases of Zika, which is usually associated with mild symptoms, although severe symptoms may also occur, including Guillain-Barré syndrome and birth defects in babies, according to the U.S. Centers for Disease Control and Prevention. Of those, 256 were locally acquired. So far this year, four more cases have been reported, all travel-related.
Barry Alto, a UF/IFAS assistant professor of medical entomology, said scientists need better diagnostic tools to detect Zika virus to meet challenges to public health. He is working with collaborator Steven Benner at Firebird Biomolecular Sciences LLC to develop methods they hope should take about an hour – far less time than current testing methods. Existing methods require specialized equipment and highly trained personnel, so samples must be transported to specialized laboratory facilities to perform the tests.
Alto will work with Benner, a former UF chemistry distinguished professor and founder of Gainesville-based Firebird Biomolecular Sciences LLC. Together, they plan to develop an inexpensive, user-friendly and rapid diagnostic Zika test.
“The project has the potential to impact the health of Floridians,” said Alto, a faculty member at the UF/IFAS Florida Medical Entomology Laboratory in Vero Beach, Florida. “It can improve surveillance by advanced warning of Zika transmission through tests of mosquito samples, allow for strategic deployment of limited resources by mosquito control to reduce incidence and prevalence of Zika and improve health care to Floridians by rapid diagnosis in human samples.”
Alto and Benner will combine current Zika-detection techniques with innovations in synthetic biology. Those include AEGIS (artificially expanded genetic information system), which allows pathogen nucleic acid-targeted tests to be ultra clean, and SAMRS (self-avoiding molecular recognition systems) that allow ease of multiplexing of pathogen nucleic acid-targeted test so other arboviruses can be detected in addition to Zika virus.
During the one-year project, scientists will travel to Florida’s public health service labs to demonstrate the technique and to test their method to detect Zika and other arboviruses.
“We are interested in getting feedback from individuals involved in mosquito control and public health,” Alto said.
Zika can be transmitted when a female mosquito, most likely an infected Aedes aegypti, bites a human. The virus can cause birth defects, including microcephaly, or a smaller-than-normal head, in babies as well as Guillain-Barré syndrome, a condition in which the immune system attacks your nervous system. Currently there is no vaccine available for Zika virus.
To try to avoid mosquito bites, UF/IFAS Extension faculty urge people to stay indoors or wear long-sleeve shirts and pants if they’re outdoors, especially during the day, when mosquitoes that might transmit the Zika virus are more likely to bite. They also urge people to apply mosquito repellent containing DEET and remove mosquito-breeding habitats by removing water from containers because that’s where mosquitoes lay their eggs and the immature stages develop.
Antimicrobial agents – such as antibiotics – have dramatically reduced the number of deaths from infectious diseases since their introduction 70 years ago. However, through their overuse and misuse, many micro-organisms have become resistant to them. It is estimated that each year this growing antimicrobial resistance (AMR) causes around 25,000 deaths and accounts for over EUR 1.5 billion in healthcare costs and productivity losses in Europe alone, making it one of the greatest challenges facing society today. To boost development and bring new and innovative players to AMR research, the EU issued a prize for the individual or team that most effectively meets the following challenge: ”to develop a rapid test that will allow healthcare providers to distinguish at the point of care between patients with upper respiratory tract infections that require antibiotics and those that can be treated safely without antibiotics”.
“This prize is a great recognition of how collaboration can lead to innovative diagnostic solutions that improve patient care,” said Marcel van Kasteel, CEO of Handheld Diagnostics at Philips. “The HNL program for detection of bacterial infections perfectly fits with our ‘open platform’ strategy of bringing innovative biomarker content onto the Minicare I-20 platform in order to offer healthcare professionals a panel of relevant tests for acute settings. Activities are ongoing to further develop the HNL test for eventual implementation in routine clinical practice.
“In various studies, HNL has demonstrated superior performance compared to biomarkers currently used to diagnose bacterial infection,” said Per Venge, CEO of P&M Venge AB. “I am therefore very excited that we have been able to successfully demonstrate the detection of HNL on the Minicare I-20 using blood samples from patients with upper respiratory tract infections in the Uppsala University hospital, where within a few minutes patients with a bacterial infection could clearly be distinguished from those with viral infections or other conditions.”
Based on Philips’ proprietary biosensor technology, the Minicare I-20 handheld diagnostics platform is designed to detect multiple target molecules at very low concentrations in a single ‘finger-prick’ blood sample, and display the results on a handheld analyzer within minutes. Philips already has CE marking for its Minicare I-20 based cardiac troponin I (cTnI) blood test for the rapid point-of-care diagnosis of heart attack, and it is currently developing further tests for acute care settings.
Minicare I-20 is simple and easy to use by non-laboratory staff. The analyzer’s built-in connectivity allows direct transfer of the data to laboratory and hospital information systems to update patient files, while integrated calibration and fail-safe functionalities ensure the robustness and accuracy needed for confident on-the-spot decision making.
TruQuick(TM) is a qualitative lateral flow chromatographic immunoassay menu of over 60 products. TruQuick(TM) rapid tests can aid in the diagnosis of infectious pathogens and other important acute diseases in 10 to 20 minutes with high levels of accuracy and speed to results. Meridian understands the clinical testing requirements in Asia and other emerging markets for speed, sensitivity, specificity, and breadth of product line.
Lourdes Weltzien, Ph.D., President of Meridian Asia Pacific commented, "We are excited to launch the new TruQuick(TM) brand of rapid tests for the rapidly growing point-of-care market in the Asia Pacific region. As for other regions of the world, Meridian will quickly introduce the TruQuick(TM) brand of products based on regional demands and registration priorities."
Richard L. Eberly, President, Chief Commercial Officer, stated, "One of Meridian`s key strategies over the past few years has been to expand our global commercial operations in emerging markets around the world. Meridian has expanded operations in China, Singapore, Australia, Africa, and South America. The product portfolio for these emerging markets is rapidly expanding. We are delighted to add the TruQuick(TM) brand of rapid point-of-care products to our commercial channels in these important markets."
"The GenePOC CDiff test will fulfill the increasing market need for affordable, fully automated and easy to use testing at Point of Care as early detection of C. difficile can lead to better control and management of the infection, which in turn can improve patient health, reduce the risk of transmission, and potentially lower mortality and morbidity", Patrice Allibert CEO of GenePOC commented. "We are also delighted to start our commercialization with the signing of these additional collaborations. We have seen first-hand the enthusiasm of our partners during our first distributors' meeting in Q4 of 2016 and in recent pre-launch interactions. We expect the combination of exceptional products and partners to lead to rapid adoption of the revogene™ platform", he continued.
The commercial partners signed up today are Astra Formedic S.r.l. in Italy , bestbion dx GmbH in Germany /Austria, Biosynex Group in France, EMM Life Science AB in Sweden/ Denmark / Finland /Nor-way/ Iceland , Fannin Ltd in Ireland , Mediphos Group BV in Netherlands / Belgium / Luxembourg , Near Patient Diagnostics Ltd in the UK, Vitro S.A.B. de C.V. in Spain / Portugal , Sedeer Medical direct or through partners in Qatar , Iran , United Arab Emirates , Bahrain , Kuwait and Oman , and Bühlmann Laboratories in Switzerland . Negotiations are ongoing for those countries not listed yet and GenePOC expects to sign on additional distributors in the coming months to best serve customers initially in the EMEA region and later in the year globally.
The procedure utilizes luminescent magnetic microparticles, which are coated with selected bacteriophages to quickly identify potential bacterial species in patients.
Current methods to identify bacterial infections take several days while samples are taken to see if bacteria grow in a petri dish in a laboratory.
"Faster, better, cheaper - we managed to achieve all of these objectives," Dr. Jan Paczesny, who led the research project, said in a press release. "This can be seen by any interested party as, in full awareness, we relinquished patent protection."
Researchers used a flow cytometer, a simple and inexpensive device used in blood tests, to identify bacteria. A sample is passed through the cytometer via a narrow nozzle that forces larger particles, such as cells, to travel through one by one. The stream flowing through the cytometer is lit by lasers and uses detectors to record the light reflected from individual particles.
In order to easily label the bacteria to be intercepted and identified, researchers created special bioconjugates, or complexes formed by combining microparticles with biomolecules. The biological element to do this was bacteriophage, or a virus infecting a particular species of bacteria.
The bacteriophages were combined with microparticles that could emit light to easily be registered on the cytometer along with showing magnetic properties.
"We started by searching for inexpensive, commercially available microparticles that met our requirements," Marta Janczuk-Richter, Ph.D. student, said in a press release. "It turned out that appropriate particles were already available on the market - and exactly the ones we were looking for. Their surface was covered with just those chemical functional groups we needed to place virtually any type of bacteriaphage on them."
Researchers found that several bioconjugates attach to each bacteria allowing for the detection of a single bacterium. This procedure could easily be adapted by hospitals to test for a variety of bacteria.
The study was published in Bioconjugate Chemistry.
PathogenDx and Emerald Scientific Enter Into Distribution Agreement to Supply PDx-C Ultra-Rapid Pathogen Detection Kits to Cannabis Testing Labs
The PDx technology provides the only DNA-based test that can detect for multiple pathogens simultaneously. The increased throughput enables cannabis producers to more rapidly move product through the supply chain. Milan Patel, PathogenDx CEO, commented, "This agreement is ground breaking for PathogenDx because it combines the unmatched reach of Emerald Scientific with the PathogenDx technology allowing each to leverage the strengths of each company." Emerald Scientific will officially release the PDx-C kits at the Emerald Conference on February 2nd and 3rd in San Diego. "The Emerald Conference is the premier scientific cannabis conference, showcasing the latest scientific products in the industry, so it really provides us with an excellent opportunity to present this new technology," said Kirsten Blake, Director of Sales and Business Development for Emerald Scientific.
Dr. Carl Yamashiro, VP for Product Development, stated that this is the first of a number of products to be released for PathogenDx, which will be coming to the market during 2017. Products include testing for pathogens in food, agriculture and water.