Sunday, April 23, 2017
With our new MBT STAR®-Carba IVD kit, Bruker expands the MALDI Biotyper workflow beyond accurate and very broad microbial identification to additional fast functional testing of resistance against selected antibiotics of high clinical relevance. The MBT STAR-Carba IVD kit is the first validated diagnostic assay for mass spectrometry-based resistance testing on the market. It offers rapid turnaround time, and also gives information on the resistance mechanism. Independent of the resistance gene(s) involved, this novel assay detects the bacterial antibiotic resistance mechanism, e.g. the degradation of carbapenems, from isolates or from positive blood cultures. Specifically, the MBT STAR-Carba IVD assay is testing against carbapenem-resistance in Gram-negative bacteria, thus addressing a currently urgent healthcare problem. The MBT STAR-Carba IVD Kit and Software Module for the automated data interpretation are labeled according to EU directive EC/98/79. Bruker is planning to further expand the portfolio of MBT STAR assays in the future for the detection of additional resistance mechanisms.
Bruker is also announcing important enhancements for routine MALDI Biotyper microbiology fast identification workflows, including a MBT Mycobacteria IVD Library and Software Module, labeled according to EU directive EC/98/79, which make mycobacteria identification available for clinical diagnostic purposes. The new library covers 164 out of currently 180 described mycobacteria species, and it is by far the most comprehensive library for MALDI-based mycobacteria identification on the market.
For research use only, Bruker is further broadening its application portfolio of the MBT Subtyping Module. This MALDI subtyping module now also enables the automated differentiation between Mycobacterium chimaera and Mycobacterium intracellulare, and between the pathogenic Listeria monocytogenes and other Listeria species.
Professor Dr. Sören Schubert from the Max-von-Pettenkofer Institute at the Ludwig-Maximilians University in Munich, Germany stated: "I am impressed by the continuous innovations that Bruker offers on the MALDI Biotyper platform. The new diagnostic MBT STAR-Carba IVD assay is of significant clinical relevance, because carbapenemase producing bacteria are a growing healthcare concern and rapid, functional analysis is very important. This novel assay for rapid resistance testing for selected antibiotics can be run on the same MALDI Biotyper platform which has been successfully used for identification of bacteria and fungi in the microbiological lab. This is yet another milestone for the broad introduction of MALDI-TOF technology into clinical routine microbiology."
Moreover, Bruker introduces two novel CE-IVD marked, real-time PCR assays from its recently established Glasgow molecular testing branch:
The new Fungiplex® Aspergillus multiplex, real-time PCR assay in less than 2 hours from extraction identifies the most common pathogens associated with invasive aspergillosis, providing rapid results with high sensitivity and specificity, and without the need for any culture. For this assay, DNA can be extracted from whole blood, serum, plasma and bronchoalveolar lavage (BAL), so that the Fungiplex Aspergillus assay can support clinicians in providing an earlier diagnosis of invasive aspergillosis in order to improve patient outcomes, or alternatively reduce the cost of unnecessary anti-fungal drugs.
The new Carbaplex® assay is a multiplex, real-time PCR assay that detects and differentiates the most important carbapenemase gene families, namely KPC, NDM, VIM, IMP and OXA-48-like, in less than 3 hours from extraction. The assay is validated against DNA extracted from rectal swabs with no need for any culture. The test can also be used to identify these genes from isolates as a confirmatory test. The Carbaplex assay offers the potential to rapidly identify colonization and improve patient management decisions.
Dr. Lewis White, Principal Clinical Scientist at NPHS Microbiology Cardiff, commented on the new Fungiplex Aspergillus assay: "Fungal diseases such as Invasive Aspergillosis pose an extremely serious healthcare risk to immunocompromised patients, especially in the haemato-oncology cohort. Current diagnostic methods, including culture, struggle due to low sensitivity. Expensive prophylactic and empiric drug use is common, whereas PCR, as a key component of combined biomarker surveillance strategies, prevents the overuse of unnecessary antifungals and allows the targeted use of antifungal drugs. Bruker's Fungiplex Aspergillus real-time PCR assay, when combined with international recommendations on DNA extraction, provides a standardised approach that displays excellent clinical sensitivity and specificity, providing a commercial solution with the potential to improve the diagnosis and treatment of at-risk patients."
“We are very pleased to bring the first of our three blood culture identification panels to the European market. Rapid diagnosis of blood stream infections can have significant impact on improving patient outcomes and reducing cost of therapy. GenMark’s approach will enable this by providing the broadest pathogen inclusivity and drug resistance markers of any multiplex molecular solution on the market today,” said Hany Massarany, President and Chief Executive Officer of GenMark.
“Fungal blood stream infections are some of the most critical conditions we face in the clinical laboratory and diagnosing them quickly and accurately has a significant positive impact on patient outcomes. The ePlex Fungal Pathogen Panel brings rapid and essential information regarding fungemia and its ease of use allows a perfect integration in the routine workflow,” stated Dr. Danièle Maubon, MD, PhD, of Grenoble Alpes University Hospital.
Information on the GenMark Sepsis Solution will be highlighted at the 27th European Congress of Clinical Microbiology and Infectious Diseases Meeting (ECCMID) in Vienna, Austria, from April 22-25, 2017, during conference poster sessions and a private customer symposium.
The 240-bottle instrument can simultaneously determine the Gram status and ID of a sample directly in the blood culture bottle in roughly the time it takes current methodologies to only detect the presence of infection. The disposable CSA changes color based on the unique volatile metabolites that a microorganism emits. By obtaining the "fingerprint" of the bacteria during incubation, the system provides ID hands-free, improving workflow while reducing costs and speeding time-to-action, saving patient lives. "This system is the product of years of development by the Specific team," said Paul A. Rhodes, Ph.D., CEO of Specific. "We are looking forward to introducing our first commercial offering to the market, and to sharing news of more transformative products, including our innovative new AST system, which will be introduced at ECCMID."
Sepsis, the byproduct of blood infection, is the number one killer in hospitals, killing more patients than breast cancer, prostate cancer and AIDS combined and costing the healthcare industry over $20 billion to manage. Lives are lost due to slow methodologies requiring many stages of technician involvement. Specific provides a rapid, accurate, automated new alternative paradigm to accelerate results, enabling physicians around the globe to more effectively manage patients.
Specific and its founders have written almost 60 peer-reviewed publications, detailing the successful demonstration of the CSA technology. The Company itself has independently authored over 20 scientific publications and conference abstracts regarding the CSA-powered detection and ID instrument and antibiotic susceptibility testing (AST) system.
Specific will be showcasing two abstracts at ECCMID 2017, one detailing data demonstrating that our novel antibiotic susceptibility testing system provides MIC directly from positive blood culture in 3 hours, with the second reporting a novel and unique CRE signature of E coli which emerges during primary culture. Both capabilities are of significant clinical importance, and will be presented to the field for the first time at ECCMID. Check out "SpecifAST: rapid, low cost and automatable MIC determination directly from positive blood culture" at P0181 from 15:30 – 16:30 on Saturday, 22 April and "A signature of carbapenem resistance observable during growth of Escherichia coli in spiked blood culture obtained with a colorimetric sensor array" at P1575 from 13:30 – 14:30 on Monday, 24 April.
About the rapID DxTM System
During culture, microorganisms produce volatile metabolites unique to each species and in some cases to their strain. Utilizing an inexpensive printed chemical sensor array to obtain a fingerprint that combines detection and identification into a simple, automated single step, the novel rapID DxTM system identifies microorganism from a phenotypic metabolomic signature obtained during growth.
This was the first systematic head-to-head evaluation of the most widely used rapid diagnostic tests. The eight HIV rapid diagnostic tests were evaluated using samples from Cameroon, Democratic Republic of Congo, Guinea, Kenya and Uganda. The main findings, which were published in the Journal of the International AIDS Society in March 2017, were as follows:
- All eight HIV rapid diagnostic tests that were evaluated showed very high sensitivity (i.e. capacity of correctly detecting an individual with HIV infection), ranging from 98.8% to 100%.
- However, the specificity (i.e. the tests’ ability to correctly identify individuals without HIV infection) varied greatly ranging from 90.4% to 99.7%.
- Several factors, including gender, provider-initiated testing and the geographical origin of specimens, were associated with false-positive results. Additional investigations are needed to explore this.
“This publication reports on the performance of individual HIV rapid tests, but not the accuracy of entire HIV testing algorithms,” says MSF’s Dr Cara S Kosack, author of the article in the Journal of the International AIDS Society. “The results underscore the challenges in designing accurate testing algorithms, and the need for local validation to be part of the design process.”
MSF has conducted a complementary analysis on the performance of HIV testing algorithms. This has been submitted for publication in a medical peer-reviewed journal.
For more details about the evaluation, please see: http://www.jiasociety.org/index.php/jias/article/view/21345
PathogenDx, Inc. Launches Disruptive Environmental Screening Technology for Growers and Cultivators in the Legalized Cannabis Sector
The PDx technology provides the only DNA based test that can detect for multiple pathogens simultaneously. Milan Patel, CEO of PathogenDx, commented that the application is easy and simple, with one swab being able to provide the contamination information for up to 30 pathogens. Current environmental screening methods used today takes days for results, and growers would have to apply up to 30 different swabs for the same number of pathogens. The PDx-Es test is ground breaking in that it will be the only test available where results can be delivered within a day’s shift after swabs have been collected.
Damon Nutt, owner and Master Grower of Arizona Cannabis Society, commented that PDx Technology will put his patients at ease because it allows for rapid determination of contamination but also allows him to know his facilities are clean and if there is an issue, he will know within one day! “We have used this test with soil, water, air filters and swabs and we know for sure what we are introducing into our plant’s environment.”
Dr. Carl Yamashiro, the company’s VP of Product Development, stated that this is the second of a number of products to be released by PathogenDx, which will be coming to the market during 2017. Products include testing for pathogens in food, agriculture and water, see www.pathogendx.com. Because PathogenDx uses its proprietary low cost and flexible microarray technology, PDx can keep up with the ever changing microbial testing requirements with few or no adjustments. With this product, the company has focused in simplifying the sample collection process without the need to do overnight enrichment or incubation. Specialized or custom pathogen or microbial panels for environmental testing can be developed in a matter of a few months or less by PathogenDx.
“We’re developing spectral fingerprinting technology that enables real-time testing for pathogens and pesticides on more targets with less expensive equipment.” Craig Carlson, president of sales and marketing for Palo Alto, Calif.-based ScanX Inc., said in an e-mail. “We have strong early-adopter interest in our technology, and our strategic objective is to bring pilot product by the end of the year.”
Carlson said the company’s initial offerings will be centered on pathogen and pesticide testing equipment and software licensing and the company has a planned pilot around listeria detection with a large leafy greens grower. The technology has applications for the entire supply chain, Carlson said.
With several patents pending, the company is in the process of raising $2 million in capital to expand infrastructure to support growth, supplement information systems, and further develop food-testing products and services. Carlson said.
Carlson said the company is working with Washington State University to validate its machinery and testing approach.
Conventional industry methods for detection and identification of foodborne pathogens, according to a news release, are classified as culture and colony counting method, immunology based method, and polymerase chain reaction method.
The downside of those methods, according to the release, is they are labor intensive and time-consuming, since tests typically need to include enrichment, colony isolation, and confirmation. That process can take from two to three days for initial results and as long as seven days for confirmation.
The company uses a Surface-enhanced Raman spectroscopy or surface-enhanced Raman scattering (SERS) for its testing method.
ScanX aims to take lab testing capabilities into the field for “real time” pathogen and pesticide detection, according to a news release.
The company is supported by a partnership with a global spectroscopy company that develops, manufactures, sells and supports new optical measurement technology, Carlson said.
SERS could be applied for different purposes including, detection of foodborne bacteria and viruses, detection of food adulteration, chemical residue, differentiating the bacteria, detecting bacteria in human blood, rapid detecting the contaminations, and using it for rapid detecting the pathogenic bacteria.
The release said the technology offers promise to reduce foodborne illness, trim testing expenses, cut food waste and extend perishable freshness and cut recall expenses. Carlson said the company also plans to develop the first global contamination database to allow growers to see trends other producers are seeing.
Current rapid testing technology for pathogens delivers about a 75% level of certainty in test results; Carlson said ScanX scientists are aiming for 95% certainty or higher.
The company plans to participate in this years June 14-15 FutureTEC Zone at the United FreshTEC Expo, Carlson said.
The 2017 United FreshTEC Expo boasts more than 25 top ag tech start-up companies in the newest show floor destination area, the FutureTEC Zone, June 14-15 in Chicago.
Backed by over €4m of European Commission funding, the new photonics technology employs surface plasmon resonance, a procedure that reads information from a refracted laser beam to provide fast, accurate and inexpensive detection.
The group says the scanner will spot the deadly legionella bacteria in under one hour, a process that normally takes 10 days of cultivation and analysis.
Project POSEIDON (Plasmonic-Based Automated Lab-on-Chip Sensor for the Rapid in-Situ Detection of Legionella) is being coordinated by Clivet in a consortium of businesses from across Europe including Protolab (Italy), Catlab (Spain), Metrohm Applikon (Netherlands), and Uppsala University(Sweden).
“POSEIDON is a first for detecting legionella with light and provides an inexpensive, user-friendly, state of the art early warning system on an air conditioning unit,” said the consortium’s scientific coordinator, Roberto Pierobon of Veneto Nanotech.
“We aim to reduce the time involved in a diagnosis from 10 days to less than 1 hour. In order to prevent outbreaks at critical times of the year, we should be talking about a matter of minutes, rather than days,” he added.
Virtually all of the bacteria cells in the sample are said to be delivered to the sensing unit, giving extremely high sensitivity and specificity.
Hoping to have the technology ready within three years, Clivet CEO Bruno Bellò, the project coordinator, said: “The exciting feature of this device is that with future development, it could be recalibrated to look for other pathogens, which would provide incredible safety options for the environmental, medical or food industries.”