Bruker Introduces New Clinical Microbiology Assays and Kits

At the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Bruker introduced important new clinical microbiology assays and consumables kits to further enhance the MALDI Biotyper® (MBT) platform.  Bruker also introduced novel, real-time PCR assays and kits for fast molecular testing of invasive aspergillosis and carbapenem resistance.

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."

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GenMark Diagnostics Announces CE Mark for ePlex Blood Culture Identification Fungal Pathogen Panel

GenMark Diagnostics, Inc. announced it has achieved CE Mark under the European In‐Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel. BCID-FP is the first panel in the GenMark Sepsis Solution, which will also include BCID Gram-Positive and Gram-Negative panels.

“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.

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Specific Unveils Instrument Providing Detection, Gram Status and Identification for Blood Culture

Specific, which has developed innovative paradigms for detection, identification (ID) and antibiotic susceptibility testing (AST) of microorganisms growing in culture, announces today that the Company will showcase its initial commercial instrument and consumable offerings at ECCMID in Vienna, Austria from April 22-25. This marks the introduction of the first instrument that will leverage the innovative Colorimetric Sensor Array (CSA) technology pioneered by Specific to accelerate time to result by combining detection with Gram status determination and ID of blood infection.  Specific will be exhibiting at booth 13B in Hall B.

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.

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MSF Publishes Study on the Accuracy of HIV Rapid Diagnostic Tests

An evaluation of the accuracy of HIV tests in five sub-Saharan African countries has been carried out by Médecins Sans Frontières (MSF). The study was conducted in collaboration with the Institute of Tropical Medicine in Antwerp, and co-investigators from the respective ministries of health. It confirmed the need to carefully select multiple HIV rapid diagnostic tests (RDTs) in an algorithm/sequence for making an HIV diagnosis.

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.  

These findings confirm that the diagnosis of HIV should not be based on results from a single HIV rapid diagnostic test. A combination of HIV tests, and more specifically an algorithm/sequence of tests of two or three different HIV rapid tests, is required to make an HIV-positive diagnosis. This is recommended by the World Health Organization (WHO) and followed by MSF in its programmes.

“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

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PathogenDx, Inc. Launches Disruptive Environmental Screening Technology for Growers and Cultivators in the Legalized Cannabis Sector

PathogenDx is pleased to announce that it has developed an Ultra-Rapid Environmental Screening test for the Cannabis Sector. This is the second product offering from the company after the launch of its PDx-C technology for regulated microbial testing within the medical and recreational cannabis sector. The product to be branded as PDx-Es for Environmental Screening, will specifically target growers and cultivators who are at major risk of contamination during their grow cycles. The testing services offered with this product would be available either through partnering labs carrying the PathogenDx technology, or growers directly interested in acquiring the capability. The PDx-Es technology is extremely simple and easy to administer. Swabs of working surfaces, ancillary equipment, and mechanicals are taken, and then sent to a local lab for testing. Within 48 hours of receipt, results of detection of human pathogen will be available. The value of the rapidity and frequency of this data will allow growers to identify contamination levels within the surroundings of the cultivation, and know where to sterilize and clean those areas and take preventive action from spreading.

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.

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ScanX Looks to Accelerate Rapid Testing Technology

Increasing the speed, scope and simplicity of pathogen and pesticide testing is the goal for ScanX Inc.

“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.

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Clivet to Begin Legionella Detection Research Project

Italian air conditioning equipment manufacturer Clivet is behind the development of a new process for the rapid detection of legionella.

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.”

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Alere Achieves FDA Clearance for Alere™ Reader Platform and Alere BinaxNOW® Influenza A & B Card 2

Alere Inc., a global leader in rapid diagnostics, announced that its Alere™ Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510(k) marketing clearance from the US Food and Drug Administration (FDA). The Alere Reader will be initially available for use with the BinaxNOW® Influenza A & B Card 2, with other lateral flow applications and assays to follow. This reformulated test card is the first rapid antigen influenza test to achieve 510(k) clearance as a Class II assay under the new FDA reclassification requirements.                  

This announcement represents the introduction into the US market of the Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a wide variety of lateral flow immunoassay formats. This follows a successful release of the Alere Reader into Europe and select Asian markets since In-Vitro Diagnostic (IVD) CE marking in August 2016.

With the intent to expand the settings in which this platform can be deployed, Alere expects to promptly submit an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere BinaxNOW Influenza A & B Card 2 test for use on the Alere Reader.

"The Alere BinaxNOW Influenza A & B Card 2 test with the Alere Reader, improves what is already a leading rapid testing solution for influenza diagnosis in two key ways: by eliminating operator subjectivity and by connecting test results with information management systems," said Avi Pelossof, Alere Global President of Infectious Disease. "The Alere Reader platform, paired with Alere's market-leading lateral flow portfolio, will ensure that over time this novel technology will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings."

The Alere Reader helps support key goals of healthcare and regulatory stakeholders by ensuring the accuracy and reproducibility of test results. By utilizing the Alere Reader at the point-of-care, providers can obtain highly accurate results within an actionable timeframe and then administer the appropriate treatment quickly. In addition to the Alere Reader, Alere's extensive flu portfolio includes: Alere™ i Influenza A & B, the first-ever CLIA-waived molecular flu test, and the Alere™ Influenza A & B dipstick test.

With the Alere Reader, physicians, lab technicians and other healthcare personnel insert test cards into the platform, which detects, identifies and analyzes the completed lateral flow assay. Results are displayed on an intuitive touch screen, can immediately be linked to patient electronic medical records and back-end information systems, or can be printed. Further, the Alere Reader provides the user additional confidence in the results with an automated function that ensures quality controls have been tested.

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Scientists Unveil CRISPR-based Diagnostic Platform

A team of scientists from the Broad Institute of MIT and Harvard, the McGovern Institute for Brain Research at MIT, the Institute for Medical Engineering and Science at MIT, and the Wyss Institute for Biologically Inspired Engineering at Harvard University has adapted a CRISPR protein that targets RNA (rather than DNA), for use as a rapid, inexpensive, highly sensitive diagnostic tool with the potential to transform research and global public health.

In a study published in Science, Broad Institute members Feng Zhang, Jim Collins, Deb Hung, Aviv Regev, and Pardis Sabeti describe how this RNA-targeting CRISPR enzyme was harnessed as a highly sensitive detector — able to indicate the presence of as little as a single molecule of a target RNA or DNA. Co-first authors Omar Abudayyeh and Jonathan Gootenberg, graduate students at MIT and Harvard, respectively, dubbed the new tool SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing); this technology could one day be used to respond to viral and bacterial outbreaks, monitor antibiotic resistance, and detect cancer.

The scientists demonstrate the method’s versatility on a range of applications, including:

• detecting the presence of Zika virus in patient blood or urine samples within hours;
• distinguishing between the genetic sequences of African and American strains of Zika virus;
• discriminating specific types of bacteria, such as E. coli;
• detecting antibiotic resistance genes;
• identifying cancerous mutations in simulated cell-free DNA fragments; and
• rapidly reading human genetic information, such as risk of heart disease, from a saliva sample.

Because the tool can be designed for use as a paper-based test that does not require refrigeration, the researchers say it is well-suited for fast deployment and widespread use inside and outside of traditional settings — such as at a field hospital during an outbreak, or a rural clinic with limited access to advanced equipment.

“It’s exciting that the Cas13a enzyme, which was originally identified in our collaboration with Eugene Koonin to study the basic biology of bacterial immunity, can be harnessed to achieve such extraordinary sensitivity, which will be powerful for both science and clinical medicine,” says Feng Zhang, core institute member of the Broad Institute, an investigator at the McGovern Institute, and the James and Patricia Poitras ’63 Professor in Neuroscience and associate professor in the departments of Brain and Cognitive Sciences and Biological Engineering at MIT.

In June 2016, Zhang and his colleagues first characterized the RNA-targeting CRISPR enzyme, now called Cas13a (previously known as C2c2), which can be programmed to cleave particular RNA sequences in bacterial cells. Unlike DNA-targeting CRISPR enzymes (such as Cas9 and Cpf1), Cas13a can remain active after cutting its intended RNA target and may continue to cut other nontargeted RNAs in a burst of activity that Zhang lab scientists referred to as “collateral cleavage.” In their paper and patent filing, the team described a wide range of biotechnological applications for the system, including harnessing RNA cleavage and collateral activity for basic research, diagnostics, and therapeutics.

In a paper in Nature in September 2016, Jennifer Doudna, Alexandra East-Seletsky, and their colleagues at the University of California at Berkeley employed the Cas13a collateral cleavage activity for RNA detection. That method required the presence of many millions of molecules, however, and therefore lacked the sensitivity required for many research and clinical applications.
The method reported today is a million-fold more sensitive. This increase was the result of a collaboration between Zhang and his team and Broad Institute member Jim Collins, who had been working on diagnostics for Zika virus.

Working together, the Zhang and Collins teams were able to use a different amplification process, relying on body heat, to boost the levels of DNA or RNA in their test samples. Once the level was increased, the team applied a second amplification step to convert the DNA to RNA, which enabled them to increase the sensitivity of the RNA-targeting CRISPR by a millionfold, all with a tool that can be used in nearly any setting.

“We can now effectively and readily make sensors for any nucleic acid, which is incredibly powerful when you think of diagnostics and research applications,” says Collins, the Termeer Professor of Medical Engineering and Science at MIT and core faculty member at the Wyss Institute. “This tool offers the sensitivity that could detect an extremely small amount of cancer DNA in a patient’s blood sample, for example, which would help researchers understand how cancer mutates over time. For public health, it could help researchers monitor the frequency of antibiotic-resistant bacteria in a population. The scientific possibilities get very exciting very quickly.”

One of the most urgent and obvious applications for this new diagnostic tool would be as a rapid, point-of-care diagnostic for infectious disease outbreaks in resource-poor areas.

"There is great excitement around this system," says Deb Hung, co-author and co-director of the Broad's Infectious Disease and Microbiome Program. "There is still much work to be done, but if SHERLOCK can be developed to its full potential it could fundamentally change the diagnosis of common and emerging infectious diseases."

“One thing that’s especially powerful about SHERLOCK is its ability to start testing without a lot of complicated and time-consuming upstream experimental work,” says Pardis Sabeti, also a co-author in the paper. In the wake of the ongoing Zika outbreak, Sabeti and the members of her lab have been working to collect samples, rapidly sequence genomes, and share data in order to accelerate the outbreak response effort. “This ability to take raw samples and immediately start processing could transform the diagnosis of Zika and a boundless number of other infectious diseases,” she says. “This is just the beginning.”

Additional authors include Jeong Wook Lee, Patrick Essletzbichler, Aaron J. Dy, Julia Joung, Vanessa Verdine, Nina Donghia, Nichole M. Daringer, Catherine A. Freije, Cameron Myhrvold, Roby P. Bhattacharyya, Jonathan Livny, and Eugene V. Koonin.

Source: MIT News

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Specific Technologies Announces Faster Detection and ID of Yeast in Blood Culture

Specific Technologies, which has developed SpecID™, an innovative paradigm for detection and identification of pathogenic microorganisms based on their volatile metabolic signatures, announces today the publication of a study in PLOS ONE detailing the demonstration of the SpecID™ system to detect and identify pathogenic yeasts in simulated blood culture.

In the study, Cleveland Clinic researchers identified 7 species of pathogenic yeasts in blood culture with 95% accuracy, faster than current methodologies that can only detect the presence of infection. These key findings further demonstrate the SpecID™ system's unique capabilities to provide a faster identification of the cause of sepsis. Sepsis is the most expensive condition and leading cause of deaths in U.S. hospitals, costing more than $20 billion annually.  Sepsis occurs in about 10% of U.S. hospital patients, but contributes to up to 50% of all hospital deaths. Early diagnosis of sepsis is critical to improving patient survival rate, which decreases every hour without effective antibiotic treatment.

The authors of the study compared Specific's colorimetric sensory array (CSA) technology to the industry standard, bioMérieux's BacT/ALERT® system, and reported that SpecID™ accurately detected the presence of yeasts 6.8 hours (17%) faster than BacT/ALERT® on average. Further, the metabolomic "fingerprint" obtained by the sensor enabled discrimination of distinct species with 95% accuracy.  The SpecID™ system thus combines earlier detection with the identification (ID) of species into a single, fully automated step.  This contrasts with conventional culture systems that require a separate Gram stain, growth of colonies and then ID. SpecID™ thus saves time, labor, reduces handling-related contamination and above all, speeds the availability of actionable information about deadly yeast-based blood infections to the hospital staff.

"This announcement continues to establish SpecID™ as the only technology to combine detection with ID during primary blood culture. By extending this paradigm, which we have reported for bacterial and mycobacterial infection, now to the clinically important case of yeast infection, we demonstrate a general and novel paradigm for microbiology diagnostics that promises to streamline the lab, by combining the detection, Gram status and ID of pathogens as they grow in blood culture," said Paul A. Rhodes, Ph.D., CEO of Specific.

"Improving microbiology diagnostics to better detect and characterize the causes of fungemia is important to guide antifungal therapy," said Gary W. Procop, M.D., Medical Director of Enterprise Laboratory Stewardship Committee, and Molecular Microbiology, Virology, Mycology & Parasitology Laboratories at the Cleveland Clinic Foundation.  "We look forward to evaluating new systems for not only blood culture but rapid antibiotic susceptibility testing as well in the coming months."

To view the manuscript, "The Combined Rapid Detection and Species-Level Identification of Yeasts in Simulated Blood Culture Using a Colorimetric Sensor Array," published in PLOS ONE, please visit the following link: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0173130.

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Alere Receives FDA CLIA Waiver for Alere™ i RSV Rapid Molecular Test

Alere Inc., a global leader in rapid diagnostics, announced that its Alere™ i RSV test has been granted CLIA (Clinical Laboratory Improvement Amendments) waiver by the U.S. Food and Drug Administration (FDA) for the detection of RSV (respiratory syncytial virus) infection in children and adults. The Alere i RSV test, which was cleared for marketing by the FDA in August 2016, is the first molecular test that can be used at the point-of-care to detect RSV in 13 minutes or less.

With CLIA waiver, the Alere i RSV test will be available in physician offices, hospital emergency rooms and walk-in clinics throughout the United States.

"Our innovative Alere i platform now offers the key trio of respiratory assays for rapid molecular detection of RSV, Influenza A & B and Strep A in a broad range of healthcare settings," said Avi Pelossof, Alere Global President of Infectious Disease. "Healthcare providers can now deploy the power of rapid molecular testing to quickly and accurately differentiate these potentially serious infections and link patients to the appropriate treatment."

In acute care settings, every minute counts when assessing symptomatic patients. Arming healthcare personnel with a simple-to-use, point-of-care RSV test that offers speed and molecular accuracy facilitates early and appropriate supportive care, the avoidance of unnecessary antibiotic treatment, and the rapid initiation of infection control measures to help control the spread of RSV, a highly contagious and potentially life-threatening infection.

"As of February 28, 2017, we have installed approximately 7,500 Alere i instruments across the globe. Achieving a third CLIA-waived assay on the platform demonstrates our ability to successfully bring transformational new technology to market and we look forward to further expanding the assay content and disease states of the Alere i platform," said Pelossof.

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