Tuesday, November 20, 2012

Takara Bio Partners with Pathogenica For HAI Sequencing Service in Japan

Takara Bio Inc. has announced an agreement with Pathogenica Inc., based in Boston, to market and distribute the Pathogenica HAI (Hospital Acquired Infection) BioDetection Kit in Japan. The kit is currently being sold for research use and is the first DNA sequencing analysis product that enables identification of infectious diseases with sequence-specific resolution at a scale that makes hospital-wide screening practical.

Hospital acquired infections are a globally recognized health problem, and Pathogenica's HAI BioDetection Kit enables health care providers to rapidly characterize, track, and deal with the causative agents, preserving the health of patients and helping hospitals reduce the cost of care.

Current methods for pathogen identification can take days to obtain results or are limited to a few organisms. The Pathogenica solution quickly identifies what species are present in a sample and also provides sequence data (including strain identity and resistance genes), which is critical information for understanding and containing or preventing outbreaks. The kit can detect 12 bacteria commonly associated with HAIs and 15 resistance gene families in a single assay and 12 samples can be processed per sequencing run. The kit offers an impressive "sample to result" turnaround of less than 12 hours and detects co-infections with a high degree of reliability.

In addition to selling kits, Takara Bio is offering sequencing services through its state-of-the art Dragon Genomics Center, enabling doctors and epidemiologists to send samples out to Takara, have them sequenced, and receive back the interpreted information on microbial characterization. The Pathogenica HAI solution combined with Takara Bio's sequencing service allows healthcare and research facilities of all sizes to leverage sequencing technology for obtaining useful findings to track HAIs, control outbreaks, and improve quality of care.

All products referenced are for Research Use Only and not intended for diagnostic purposes.

Abacus Diagnostica Receives CE Mark for its Rapid Direct PCR Test for Toxigenic Clostridium difficile

Abacus Diagnostica Ltd announced that it has received the CE mark for the GenomEra™ C. difficile assay for the detection of toxin-producing Clostridium difficile directly from stool samples. C. difficile is the leading cause of infectious nosocomial diarrhea in Europe and North America.

Rapid changes in the epidemiology and increasing incidence have taken the focus on methods to diagnose toxigenic C. difficile faster and more efficiently. Accurate and rapid diagnosis of C. difficile infection is crucial for patient care but also for preventing transmission and reducing the overall disease burden.

The GenomEra C. difficile assay is the newest test of Abacus Diagnostica's expanding line of easy-to-use and cost-efficient molecular diagnostics products. The C. difficile test is extremely simple to perform directly from stool specimen through a straightforward sample preparation process without extraction, heating or centrifugation steps. The assay is built on rapid and reliable target amplification and end-point detection technology that allows for high quality results in 50 minutes.

"Abacus is committed to providing a continuum of diagnostic products for key infectious diseases to meet the needs of various laboratory settings," said Tom Palenius, CEO of Abacus Diagnostica. "Along with our earlier CE marked MRSA/SA assays this PCR test will help to meet the testing and resource challenges of many different types of labs. During next year we will continue to expand our molecular test offering for critical blood stream and perinatal infections."

About the GenomEra CDX™ System Molecular Diagnostic Platform

The GenomEra CDX system is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GenomEra CDX system is designed for clinical routine use for identification of target nucleic acid sequences directly from crude clinical samples and delivering reliable non-confusing answers in less than in one hour. The GenomEra CDX system combines minimal sample preparation with rapid and high-performing PCR (polymerase chain reaction) amplification and end-point detection for fully integrated and automated nucleic acid analysis. GenomEra CDX system is the first commercial homogenous PCR platform to use thermally stable, intrinsically fluorescent time-resolved fluorometric (TRF) labels combined with a proprietary assay and measurement technology with effective elimination of background effects originating from e.g. crude clinical samples.

Saturday, November 17, 2012

DNA Sequencing of MRSA Used to Stop Outbreak

An outbreak of the hospital superbug MRSA has been brought to an end by UK doctors cracking the bacterium's genetic code. It led to them finding one member of staff at Rosie Hospital, in Cambridge, who may have unwittingly carried and spread the infection. They say it is the first time rapid genetic testing has been used to track and then stop an outbreak. One expert said this would soon become "standard practice" in hospitals.

Doctors were concerned after MRSA was detected in 12 babies during routine screening.

However, current tests could not tell if it was one single outbreak being spread around the unit or if they were separate cases being brought into the hospital. About one in 100 people carry MRSA on their skin without any health problems.

To find out, researchers at the University of Cambridge and the Sanger Institute embarked on more sophisticated version of a paternity test. They compared the entire genetic code of MRSA bugs from each baby to build a family tree. It showed they were all closely related and part of the same outbreak. After two months without a case and deep cleaning the ward, another case appeared. Analysing the DNA showed that it was again part of the outbreak and attention turned to a carrier.

Tests on 154 members of staff showed that one was also carrying MRSA, which may have been spread to babies in the unit. They were treated to remove the infection.

"We believe this brought the outbreak to a close," said Dr Julian Parkhill, from the Sanger Institute. "This is really exciting for us because it gave the hospital the opportunity to intervene. We think this is the first case where whole genome sequencing has actually led to a clinical intervention and brought the outbreak to a close."

The cost of working out the entire genetic code of a bacterium has plummeted from millions of pounds to about £50. The time it takes has also fallen dramatically from months to hours. Dr Parkhill said it could get even cheaper: "People are talking about the thousand dollar human genome. "If you can do the human genome for a thousand dollars you can do a bacterial genome for one dollar."

Commenting on the research Prof Ross Fitzgerald, from the Roslin Institute at the University of Edinburgh, told the BBC: "The study clearly highlights the power of whole genome sequencing for resolving the source and the spread of an epidemic of hospital acquired infection such as MRSA.

"It will ultimately, within a small number of years, be standard practice for any hospital outbreak. I fully expect this to be rolled out as a standard approach in UK hospitals in the very near future."

Prof Sharon Peacock, from the University of Cambridge, said she wanted to develop a simple system that could be used easily by hospitals. She said she envisioned a "black box" where the genetic sequence goes in and a simple report that can be used by hospital staff comes out.

"It could, for example, determine the species of the bacterium; it could determine antibiotic susceptibility, and it could provide information about what genes are present that are often associated with poor outcomes in patients."

Sir Mark Walport, director of the Wellcome Trust, said: "This is a dramatic demonstration that medical genomics is no longer a technology of the future - it is a technology of the here and now."

Thursday, November 15, 2012

Alberta Innovates Bio Solutions: Proposals Invited for a Smarter, Cheaper, Faster Way of Detecting Pathogenic E. Coli

A consortium of Canadian research organizations has combined efforts to fund development of an innovative test for the presence of pathogenic E. coli bacteria during food production. This funding program aims to foster continuous improvement in the safety of the Canadian food supply and create long-term health benefits for Canada.

"Food safety is always a top priority and I am pleased to support this research initiative through Genome Alberta and the Alberta Livestock and Meat Agency," said Verlyn Olson, Minister of Agriculture and Rural Development. "We must continuously explore new technology and ideas to enhance our food safety processes to ensure we are providing consumers with the safest, high quality food products available. Improving E. coli detection methods will result in important safety enhancements for our meat processing industry."

More than $1 million is available over 18 months for one or two projects to develop a genomic- based detection methodology that is rapid, sensitive, specific, affordable and field-deployable. Current turn-around time for most testing methods is about 10 hours and is typically conducted in a laboratory. "This applied research initiative will demonstrate how new genomics-based technologies can be used to help detect pathogens in meat production and food processing," said Dr. David Bailey, Chief Executive Officer of Genome Alberta.

Research teams are invited to apply to the "2012/13 Program on Research and Innovation Leading to Rapid Detection of Pathogenic E. coli." While an investigator associated with a Canadian academic institution will lead or co-lead the project, the team may tap into the best expertise globally and engage scientists within academic institutions, provincial or federal research centres, private industry or non-profit research establishments.

"Drawing together the brightest minds from multiple scientific disciplines in a team environment is a good way to stimulate ideas," said Dr. Stan Blade, Chief Executive Officer of Alberta Innovates Bio Solutions. "That's the strength of this funding initiative, and we're confident this research will lead to a rapid test that will assist the food processing industry with real time decision-making to ensure that Canadian food products are safe."

The deadline for submission of a letter of intent (LOI) is January 14, 2013, 2:00 p.m. MST. Forms and additional information are available at www.genomealberta.ca . Only the most competitive LOIs demonstrating a clear benefit to the Canadian meat industry will be invited to submit a full application.

"We expect this work will provide social and economic benefits for Canadians by ensuring a safer, more secure food supply, protecting and creating new jobs in the food industry, and safeguarding a key export commodity," said Pierre Meulien, President and CEO, Genome Canada. "This is another step forward for the Canadian bioeconomy."

Supporting enhancements to Canada's food safety system is an important priority for all funding partners, which include: Alberta Innovates Bio Solutions ($250,000), Genome Alberta on behalf of ALMA ($500,000), Genome Canada ($250,000) and additional support from the Ontario Ministry of Agriculture, Food and Rural Affairs. New testing methods and technologies arising from this program will complement other national and international research initiatives and contribute to the development of national baselines, surveillance and monitoring of E. coli across Canada.

New Biosensor for Rapid Diagnosis of Infectious Diseases Debuts at MEDICA

UK-based OJ Bio will be at MEDICA 2012 for the first time (Hall 1, F11) to showcase a new mobile phone enabled biosensor for the rapid diagnosis of infectious diseases like flu.

The state-of-the-art technology combines specialist bio-sensor materials with advanced electronics in a small hand held device for the accurate detection of illnesses from patient supplied samples.

Importantly, the device can be used at the patient's bed side or other point of care, such as a GP surgery or pharmacy, with the results being available within minutes and without samples being sent for laboratory analysis.

The quick diagnosis of diseases moved a step closer after the biosensor company secured government funding for further development work into its innovative new technology.

For the last three years OJ-Bio has worked with the UK's Health Protection Agency (HPA) to develop and test the new biosensor device. This has proven its ability to successfully detect three potent respiratory viruses much more quickly than current methods.

Included are the Influenza A and B viruses, common flu strains previously linked to some major epidemics, and Respiratory Synctyial Virus (RSV), a major cause of coughs and chest infections.

OJ-Bio has secured funds from the Biomedical Catalyst programme towards its Pounds1 million-plus project to develop the device and sees MEDICA, where it will be demonstrating a working model attached to an android phone, as an important platform to launch to international customers.

Dale Athey, chief executive of Newcastle upon Tyne-based OJ-Bio, said: "Early diagnosis is vital in the treatment of diseases for millions of people. Drugs are only effective in the first few days after symptoms appear and current tests which involve laboratory analysis of samples simply aren't fast enough.

"Our new device provides a low cost test that dramatically improves the speed of diagnosis and treatment that should hit the disease at source and limit its ability to spread."

OJ-Bio is a joint venture between the Newcastle-based biotechnology company Orla Protein Technologies Ltd. and the Japan Radio Company (JRC). Orla provides the specialist biosensor materials that are combined with JRC's advanced electronics capability to create the new 'biochip' technology platform.

The biochip allows the diagnostic device to analyse samples from the patient, with the results being displayed on a complementary hand held reading device such as a mobile phone. JRC's expertise in wireless technology also means that the detection devices can be wireless enabled allowing connectivity to healthcare networks.

OJ-Bio will now embark on a programme that will involve new product design work and multi channel biochip development, alongside further investigation into the results reader and associated software needs.

This work will involve extensive input from doctors, nurses and other healthcare staff and will result in the development of a fully working device that can be used in extensive clinical trials.

Advencis: Lynx Technology in Beta Testing

Advencis, an engineering company specializing in instrumentation for the healthcare sector and the life sciences, has announced that its rapid microbiology technology, Lynx, has entered the beta testing phase.

"After having completed our funding plan, we are now entering into a phase of testing with potential clients in the pharmaceutical and food & beverage sectors," says Joseph Pierquin, president of Advencis. "The objective of the tests, which will run until the start of 2013, is to confirm the potential of the technology for high value-added applications."

The Lynx system is a rapid microbiological platform that is unique in its ability to rapidly detect microbial contaminations, regardless of the support used (culture medium, membranes...). Completely automated, it produces results in less than 48 hours in the majority of cases, as compared to a number of days with traditional methods. Thanks to its modular design, it can handle up to 240 samples. The Lynx System is also characterized by an absence of reagents or complex staining procedures, making it remarkably easy to use and validate for users.

Wednesday, November 14, 2012

Boulder Diagnostics Announces the European Market Launch of Its SpiroFind™ Lyme Disease Diagnostic Test

Boulder Diagnostics Inc. announced today the European market launch of the CE marked SpiroFind in vitro diagnostic test for the detection of active Lyme Borreliosis. The SpiroFind test is offered as a diagnostic service by the company's clinical diagnostic service laboratory in Mellrichstadt, Germany.

The novel SpiroFind test can detect active Lyme Borreliosis through all stages of disease from early disease to late and persistent manifestation. The test is based on measuring the cellular immune response to a specific challenge with the Borrelia organism. The effectiveness of the SpiroFind test was confirmed in a clinical study at the Radboud University Nijmegen Medical Centre, which is submitted for peer-reviewed publication and for presentation at the ECCMID conference in Berlin, Germany in April 2013.

"We are proud to offer this important new tool for the correct diagnosis of Lyme disease," comments Dr. Wolfgang Pieken, CEO of Boulder Diagnostics Inc., and adds, "the SpiroFind test is the first method to query the trained immunity to Borrelia infection as a signal for active disease."

"At our clinical laboratory in Mellrichstadt, Germany, we now accept whole blood samples for testing by the SpiroFind method," states Dr. Anton Waldherr, laboratory physician of Boulder Diagnostics Europe GmbH.

Two Tests for Rapid Diagnosis of Resistance to Antibiotics Developed

Two new tests for the diagnosis of resistance to antibiotics, which have excellent sensitivity and specificity, would allow us to adapt antibiotic treatments to the individual's needs and to be more successful in controlling antibiotic resistance particularly in hospitals on a world-wide scale, researchers say.

These diagnostic tests will allow rapid identification of certain bacteria that are resistant to antibiotics and hence allow us to better adapt the treatment to the infected patients, avoid the inappropriate use of certain antibiotics, thus avoiding the over-use of certain wide-spectrum antibiotics and isolate patients infected with these resistant bacteria and thus avoid the development of epidemics in hospitals.

There is an ever-increasing number of emerging bacteria that cause cross-border epidemics. Researchers all agree on the fact that it is not the number of bacteria that is the problem, but their increasing resistance to antibiotics. The situation is particularly dramatic for certain species of bacteria, Gram-negative bacilli like enterobacteriacae.

Whereas certain antibiotics like wide-spectrum cephalosporins used to be reserved for the most serious cases, now there are cases where they are totally inactive against certain bacterial germs and consequently there is no effective antibiotic treatment for these.

Hence, we are now faced with situations where the treatment of banal infection such as urinary or intra-abdominal infections has no effect. And this puts the life of the patients at risk. Every year, an estimated 25,000 deaths in Europe are due to multi-resistance to antibiotics.

Furthermore, the development of resistance to antibiotics affects an entire aspect of modern medicine that needs efficient antibiotics.

Undetected importation of multiresistant strains from foreign countries can also considerably accelerate the diffusion of this multiresistance phenomenon.

In an attempt to slow down these increasing resistances, the Inserm researchers have developed a system that can rapidly detect the two enzymes responsible for causing resistance to the bacteria of two classes of common antibiotics: wide-spectrum cephalosprins and carpabenems.

In these tests, the presence of an enzyme indicates the presence of a resistant bacteria.

These tests are based on the acidification properties generated by the activity of the enzymes when they are in the presence of an antibiotic. If any one of these enzymes is present, the medium becomes acid and the acidity indicator (pH) turns from red to yellow.

At present, these tests can be performed using bacteria isolated from urine samples taken during a detected infection, or from bacteria present in stools.

The result is obtained in less than 2 hours as compared to 24 to 72 hours using current techniques. These tests are highly sensitive and 100 percent reliable. They are totally inoffensive since they are carried out on bacteria isolated from patients or on biological products such as urine.

"These tests are currently being assessed in order to ascertain their sensitivity directly from infected sites such as blood or urine," Patrice Nordmann, Inserm Research Director and main author of the study, said.

The findings of the study have been published in two international reviews - Emerging Infectious diseases and The Journal of Clinical Microbiology.

Delhi University Develops Inexpensive Kit to Rapidly Detect Sexually Transmitted Bacteria

Delhi University has signed an agreement with the Department of Biotechnology, Union Ministry of Science and Technology, for transferring technology to develop a diagnostic kit for “inexpensive and rapid detection” of two of the most common sexually transmitted bacteria — Neisseria and Chlamydia.

The kit is developed by Daman Saluja, a professor at Dr BR Ambedkar Centre for Biomedical Research in DU, after 10 years of research, a statement from DU Registrar Alka Sharma said on Monday.

“The university has received a signing amount of Rs 5 lakh as first installment of the Rs 15 lakh and royalty offered by the industry,” the statement said.

Tests with imported kits cost between Rs 1,200 and Rs 1,500 per examination. The kit developed by the DU professor will be much cheaper.

“An estimate will be drawn by DSS Tech Private Limited. It will take at least a year for the kits to reach the market because of the regulatory norms,” Saluja said.

“Infections from Neisseria and Chlamydia are completely treatable. But the symptoms are so obscure that people do not pay attention to them. There is no proper test or diagnosis available in the country,” Saluja said. If the infection persists, the person might suffer from infertility.

Saluja said there are cases of over-treatment in some patients. “This happens because the symptoms are similar to other diseases. As a result, the bacteria develop resistance to some of the antibiotics,” she said.

“Close to 2,000 samples from hospitals were used during the research to develop the test kit. Our test will show results within three hours and any clinical laboratory can do it,” Saluja said.

New Test Increases Diagnoses Of Drug-Resistant TB And Shortens Time To Treatment Initiation

Results from the largest multi-country implementation of a new rapid tuberculosis (TB) diagnostic test reveal a growing global crisis of drug-resistant TB (DR-TB), the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) announced today.

The data, presented at the forty-third annual Union World Conference on Lung Health in Kuala Lumpur, were collected from 25 MSF projects in 14 countries over a nearly 18-month period, where the new diagnostic test, Xpert MTB/RIF, was utilized. The new testing method resulted in an average 50 percent increase in laboratory-based diagnosis of TB, compared to sputum smear microscopy, the most commonly used TB test.

“This new TB test is helping expose the true size of the drug-resistant TB epidemic and get people on treatment faster,” said Dr. Helen Bygrave, HIV/TB specialist with MSF in South Africa. “But patients and doctors alike still struggle with the long and painful treatment for drug-resistant TB that only manages to cure about one in two people.”

The Xpert MTB/RIF test, which provides results within two hours, also detects resistance to one of the primary TB drugs, rifampicin. In an MSF project in Zimbabwe, preliminary results showed that the introduction of the test resulted in a near quadrupling of DR-TB diagnoses. In an MSF project in Swaziland, the delay between collecting a patient’s sample and starting DR-TB treatment was reduced by 79 percent, from 65.9 days to 13.9 days.

While data from the implementation of Xpert MTB/RIF revealed problems with inconclusive test results, and a simpler and easier-to-use "point-of-care" test is still needed, the test clearly represents a significant advance for timely TB and DR-TB diagnosis, and its roll-out should be encouraged.

However, the treatment of DR-TB continues to be woefully inadequate. Patients must undergo a two-year treatment with drugs that cause intolerable side effects, such as persistent nausea, psychosis and deafness. Results from MSF’s cohort of DR-TB patients show a cure rate of only 53 percent, which is slightly higher than the global average of 48 percent.

Two new drugs to treat TB—the first to be developed for the disease in almost 50 years—are expected to come to market in 2013 and are both active against drug-resistant forms of the disease. Their introduction represents a critical opportunity to improve DR-TB treatment and every effort should be made to ensure they are used in a way that allows treatment to be made more tolerable, affordable, and accessible to patients in developing countries.

“With new medicines for drug-resistant TB at the doorstep for the first time in half a century, the global health community can’t afford not to seize the opportunity of a lifetime by stopping drug-resistant TB from spiraling out of control,” said Dr. Manica Balasegaram, executive director of MSF’s Access Campaign.

MSF has been treating TB for 25 years. In 2011, 26,600 TB patients were treated in MSF-supported projects in 39 countries. Half of these projects involved treating multidrug-resistant TB (MDR-TB), with a total of 1,300 patients in 21 countries. MSF is now one of the biggest nongovernmental providers of MDR-TB care worldwide.

Monday, November 12, 2012

Quidel Receives CE Mark for Its Sofia® Legionella Fluorescent Immunoassay (FIA)

Quidel Corporation, a leading provider of diagnostic testing solutions and cellular-based virology assays, announced today that it has received the CE Mark for its Sofia Legionella FIA for use on the Sofia Analyzer for the rapid detection of Legionnaires' disease, also known as legionellosis.

The Gram-negative bacterium, Legionella pneumophila, is the cause of this life-threatening respiratory illness. The symptoms of Legionnaires' disease mimic those commonly associated with influenza, including headache, fever, muscle pain, and chills in the first day, but gradually expand to include cough and shortness of breath by day three. If diagnosed early in the infection, this disease can be effectively treated with antibiotics, but if left untreated, the disease can be fatal, especially among elderly and immunocompromised patients. In 2009, the European Center for Disease Prevention and Control reported nearly 6,000 cases of Legionnaires' disease, but stated that the actual number of cases in Europe was likely significantly under-reported.(1) In the United States, where the incidence of Legionnaires' disease has tripled in the last decade, the disease accounts for nearly 8,000 to 18,000 hospitalizations per year.(2)

Sofia is the brand name for Quidel's next generation, immunoassay system that was launched earlier this year. The Sofia Analyzer and Sofia Legionella FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, highly accurate, diagnostic result within ten (10) minutes of application of the patient's specimen. The Sofia system was 510(k) cleared in October of 2011, and its first test, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the U.S. FDA in April of 2012.

The CE Mark allows Quidel to launch its new Sofia Legionella FIA in Europe.

"We are extremely pleased to announce the CE Mark and impending launch of our fourth Sofia assay in Europe," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The Sofia Legionella FIA will provide customers with an accurate, ten-minute solution for the diagnosis of Legionnaires' disease. Receiving the CE Mark is another milestone testifying to the promise of the aggressive development program we instituted nearly three years ago -- one achievement of which is the unique Sofia immunofluorescence platform and system."

The Sofia Legionella assay uses the Sofia Analyzer, an instrument that is designed to easily incorporate new analyte-specific algorithms -- an important feature as the Sofia menu of products expands. The other Sofia immunoassays presently for sale in Europe include FIAs for Influenza A+B, Strep A and RSV.

(1) Risk for Travel-associated Legionnaires' Disease, Europe, 2009 http://wwwnc.cdc.gov/eid/article/18/11/12-0496_article.htm#r6
(2) Patient Facts: Learn More about Legionnaires' disease http://www.cdc.gov/legionella/patient_facts.htm

Disco Bacteria

Disease-causing bacteria will light up like a fluorescent shirt on a nightclub dance floor in a new rapid detection technique currently under development at the University of Sydney's Faculty of Pharmacy.

Over the last couple of decades multi-resistant bacteria, such as methicillin resistant Staphylococcus aureus, or MRSA for short, have become a serious global public health concern.

Professor of Medicinal Chemistry in the Faculty of Pharmacy, Paul Groundwater, who will lead the project titled 'Novel Fluorogenic Probes for the Selective Detection of Pathogenic Bacteria', says that his team will use fluorogenic substrates to identify specific bacterial enzymes.

In the UK, unlike Australia all patients admitted to hospital must be tested for MRSA colonisation or infection, and the methods developed in this project should allow simpler and faster identification of such pathogenic bacteria.

"At the moment, detection methods require the use of either expensive instrumentation or expert analysts, or are simple but time consuming, requiring one to two days for bacteria to be identified."

Of particular concern is that this delay gives bacteria the opportunity for cross-infection of patients, says Professor Groundwater.

"The transmission of bacterial resistance could ultimately lead to new strains of bacteria which have limited or no susceptibility to current antibacterial agents."

Building on previous work, the research team will develop growth media containing fluorogenic compounds which will only generate fluorescence in the presence of specific bacteria.

Co-investigator David Hibbs, Professor of Bio-Pharmaceutical and Structural Chemistry at the University, says: "New surveillance methods are key components of effective infection prevention and control. The rapid identification of bacterial pathogens would facilitate a more effective directed clinical treatment of the infection."

"The rapid detection of the bacterium has the potential to halt and prevent the spread of bacterial infections in a range of healthcare settings."

"There are over 200,000 cases of healthcare-associated infections, including multi-resistant organisms, in Australian acute healthcare facilities each year," he says.

Friday, November 09, 2012

BD Diagnostics, Diagenode Introduce Breath Test Kit FLU A/B for Use on BD MAX

BD Diagnostics, a global leading technology company specializing in medical technology, and Belgium-based Diagenode SA, an international biopharmaceutical company, have launched kit of primers and probes respiratory FLU A/B Diagenode for use on the BD MAX in Europe. Kit primers and probes respiratory FLU A/B Diagenode got the CE and has been validated for use on the BD MAX with RNA extraction kit BD MAX RNA-3 reagent system opened, offering customers a fully automated system that standardizes the process of extraction and a friendly laboratory workflow and improved.

"As the first joint test validated for use on the BD MAX, launch kit respiratory FLU A/B Diagenode illustrates the flexibility and versatility of the BD MAX Open System and reagents to facilitate the rapid development molecular assay tests, "said Gregory Meehan , vice president of product planning at BD Diagnostics - Diagnostic Systems.

Through collaborations with developers of diagnostics in vitro (IVD) as leading Diagenode, Comics plans to expand its range of molecular biology tests by providing diagnostic tests in vitro for several clinically relevant syndromes. "The test FLU A/B Diagenode is the first in a series of tests that we plan to launch fully validated as products bearing the CE marking on the BD MAX. The uniqueness of the BD MAX system compared to other platforms is its ability to leverage the functionality of the instrument system open throughout the validation process, "said Didier Allaer CEO Diagenode.

The expanded menu of BD MAX System and its features open, full automation and standardized workflow will enable laboratories to consolidate and standardize a broad range of molecular tests to build programmes that meet both their clinical needs present and future.

PositiveID Corporation Announces Teaming Agreement With SAIC to Pursue Defense Threat Reduction Agency Contracts

PositiveID Corporation, an emerging growth company and developer of airborne bio-threat detection systems for America's homeland defense industry as well as advanced technologies for diabetes management and rapid medical testing, announced it has signed a Teaming Agreement ("Teaming Agreement") with Science Applications International Corporation ("SAIC") (NYSE:SAI) to pursue the Defense Threat Reduction Agency ("DTRA") Indefinite Delivery/Indefinite Quantity ("IDIQ") Multiple Award Contracts supporting the Weapons of Mass Destruction ("WMD") - Defeat Technology, Arms Control, and Nuclear Technology Electromagnetic Research and Development/ Survivability and Infrastructure programs.

The Teaming Agreement pairs SAIC's system engineering and integration capabilities with PositiveID's bio-threat detection technologies. PositiveID will offer both its Dragonfly™ Rapid MD-x Cartridge-based diagnostic system (" Dragonfly") as well as its M-BAND (Microfluidics-based Bioagent Networked Detector) airborne bio-threat detector as part of the Teaming Agreement.

PositiveID's Dragonfly system is designed to deliver molecular diagnostic results from a sample in less than 30 minutes, which would enable accurate diagnostics leading to potential treatment scenarios at the point of care that are not possible with existing systems. Dragonfly is being developed further for a broad range of biological detection situations including radiation-induced cell damage within the human body, strains of influenza and other common pathogens and diseases such as E. coli, methicillin-resistant staphylococcus aureus ("MRSA") and human papilloma virus ("HPV").

PositiveID's M-BAND, developed under contract for the Department of Homeland Security Science and Technology Division, is a bioaerosol monitor with fully integrated systems with sample collection, processing and detection modules that continuously analyze air samples for the detection of bacteria, viruses, and toxins with results in as little as two hours. Results from individual M-BAND instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in the aggregate.

William J. Caragol, Chairman and CEO of PositiveID, stated, "We are very pleased to team with SAIC through this agreement, and demonstrate the value and capabilities of our Dragonfly and M-BAND technologies."

Veredus Laboratories Launches Powerful Multiplexed Molecular Diagnostic Lab-on-Chip Targeting Global Threat of Multi-Drug-Resistant Tuberculosis

Veredus Laboratories, a leading supplier of innovative molecular diagnostic tools, has launched VereMTBTM, a multiplexed molecular diagnostic chip capable of fast and accurate detection of Mycobacterium Tuberculosis Complex (MTBC) and its mutations, as well as 9 other clinically relevant non-tubercular mycobacterium. These mutations are responsible for resistance to multiple drugs and are reinvigorating the global spread of Tuberculosis.

The rise of multi-drug-resistant Tuberculosis (TB) is a global healthcare challenge. Effective treatment of TB involves accurate and fast diagnosis followed by a strict regimen of the right drugs. Shortcomings in this treatment can cause the TB infection to mutate into drug-resistant strains that can become increasingly difficult and expensive to treat. Conventional methods of accurately identifying TB infections can take up to 8 weeks. In contrast, VereMTB can complete the diagnosis and identify the specific mycobacterium causing the infection and drug resistance in less than 3 hours from natural samples*, avoiding the need for culturing, the most time-consuming part of the traditional method. Additionally due to its compact size, the system can be deployed in a wide range of settings at point-of-need.

"In 2011, 8.7 million people were diagnosed with TB and 1.4 million people died from the disease. With its ranking by the World Health Organization as the second greatest killer from a single infectious agent worldwide[1], faster diagnosis and appropriate treatment of this highly infectious disease is critical," said Dr Rosemary Tan, Chief Executive Officer of Veredus Laboratories. "We believe VereMTB fulfills a crucial need in the timely diagnosis of TB and its multi-drug resistance thus ensuring proper treatment."

The VereMTB multiplexed molecular diagnostic Lab-on-Chip was designed and tested through the TM-REST** program, as part of the European 7th Framework to develop new diagnostics to fight TB and malaria.

"STMicroelectronics is at the forefront of creating silicon technology targeted at healthcare applications," said Benedetto Vigna, Executive VP & General Manager, Analog, MEMS & Sensors Group, STMicroelectronics. "Our sensor and power-related technologies have enabled numerous innovations in healthcare, ranging from personal and portable to miniaturized and minimally-invasive devices. Using ST's Lab-on-Chip technology, VereMTB is a clear demonstration of ST's ability to leverage its technology portfolio as a strategic solution to address a global healthcare burden."

Based on STMicroelectronics' industry-proven Lab-on-Chip technology, the VereMTB chip is currently undergoing evaluations by the Chinese Center for Disease Control and Prevention in Beijing, China as part of their ongoing program to assess new technologies for TB diagnostics. According to the 2012 World Health Organization report on TB, India and China combined have almost 40 percent of the world's TB cases, and nearly 60% of multi-drug resistant cases in 2011 were in India, China, and the Russian Federation.

"At the main CDC National TB Reference Lab in Beijing, we have been evaluating VereMTB using samples, collected from across China with a special interest in detecting challenging multi-drug resistant strains that are difficult to detect using other methods," said Professor Zhao Yanlin Director of National TB Reference Laboratory and Vice Director of the National Center for Tuberculosis Control and Prevention at the Chinese Center for Disease Control and Prevention. "The speed, accuracy and comprehensiveness of the results have been very promising. We look forward to continuing our collaboration with Veredus for new breakthroughs in diagnosing TB."

VereMTB will be on display at the 43rd Union World Conference on Lung Health in Kuala Lumpur, Malaysia on 13 - 17 Nov 2012 - Booth 67, Kuala Lumpur Convention Centre. Veredus Laboratories is the Singapore-based subsidiary of STMicroelectronics (NYSE: STM), a global semiconductor leader in sensor technologies, including biosensors such as the Lab-on-Chip.

Wednesday, November 07, 2012

bioMérieux Launches VIDAS® LPT, a Fast, Ground-breaking Listeria Detection Method

VIDAS® UP Listeria (LPT) utilizes recombinant bacteriophage (phage) proteins, which offer best-in class specificity and sensitivity for the targeted and rapid detection of Listeria species in food and environmental samples. VIDAS LPT complements the company's VIDAS® UP E. coli O157 (including H7) and VIDAS® UP Salmonella, all based on phage technology.

The new VIDAS LPT assay is one of the most rapid and easy-to-use Listeria spp. screening tests for food and environmental samples. Based on phage protein technology, it is able to detect low contamination levels and provides an extremely simple enrichment protocol, which reduces laboratory hands-on time, and delivers next-day results as compared to reference methods, which require up to five days.

VIDAS LPT has already been ISO 16140 certified by AFNOR for all human foods and production environment samples. AOAC-RI validation has been initiated.

Tuesday, November 06, 2012

Rapid Flu Tests Not Always Accurate

Most rapid influenza diagnostic tests (RITDs) perform well when viral concentrations in a sample are high, but accuracy declines at lower concentrations, researchers found.

Of 11 FDA-cleared rapid tests that were commercially available during the 2011-2012 flu season, most detected viral antigens in samples with the highest concentrations, according to Roxanne Shively, MS, of the Department of Health and Human Services (HHS), and colleagues.

Detection varied, however, when the viral concentrations in a sample were lower, the researchers reported in the Nov. 2 issue of Morbidity and Mortality Weekly Report.

And one rapid test -- SAS FluAlert Influenza A from SA Scientific -- did not consistently detect the pandemic H1N1 virus or other influenza A viruses even at high concentrations.

"Clinicians should be aware of the variability of RIDTs when interpreting negative results and should collect test samples using methods that can maximize the concentration of virus antigen in the sample, such as collecting adequate specimens using appropriate methods in the first 24 to 72 hours after illness onset," Shively and colleagues wrote.

"The use of these tests for clinical management and public health practice can be improved by continually updating guidance, educating clinicians on best practices, and enhancing test design for better performance," they wrote, noting that the Joint Commission is offering two online courses dealing with strategies to improve rapid influenza testing in ambulatory settings.

The analysis was conducted as part of a collaboration between the CDC, the Biological Advanced Research and Development Authority at HHS, and the Medical College of Wisconsin. The CDC provided 16 influenza A viruses and seven influenza B viruses representative of those circulating since 2006 to the Medical College of Wisconsin.

In a controlled laboratory setting, researchers there performed three separate tests for each combination of virus and rapid test.

Shively and colleagues said that the variation in performance observed between the tests could be related to differences in their design.

"Manufacturers use different antibodies in their [rapid influenza diagnostic tests] to capture nucleoprotein antigen, and this difference in antibody selection might account for some of the variation in performance," they wrote, noting that periodic evaluation of performance might "identify needed updates in antibodies."

Because of the demonstrated variability in performance, especially at low virus concentrations, a negative test result might not exclude influenza infection, they noted.

"Therefore, antiviral treatment, if indicated, should not be withheld from patients with suspected influenza because they have a negative [rapid influenza diagnostic test] result," the authors wrote.

Primary source: Morbidity and Mortality Weekly Report
Source reference: Beck E, et al "Evaluation of 11 commercially available rapid influenza diagnostic tests -- United States, 2011-2012" MMWR 2012; 61: 873-876.

Bacteria Test Could Prevent Deadly Infections In Newborns

Researchers have developed a small cartridge that can identify harmful microbes in a newborn or the mother. It is extremely easy to use and does not require much clinical microbiological expertise.

The health worker simply adds a sample from the baby, mother, or both, and waits ten to fifteen minutes for the result. This simple, cheap and rapid test gives health care professionals useful data so that they can decide quickly what treatments to recommend.

When a baby is born, they move from the protection of the womb to an environment with literally trillions of microscopic organisms.

Douglas Weibel, biochemistry professor at the University of Wisconsin-Madison, said "While that microbial environment in the gut is still developing, the introduction of one of many of the wrong kinds of bacteria may cause a severe immune response. In an infant, the immune system could just ravage the intestines."

In remote parts of Africa, the risk of the infant's immune system ravaging the intestines is even greater. The Bill & Melinda Gates Foundation awarded Wiebel and team a Grand Challenges Explorations grant to get a simple bacterial test out on the field; one that could detect necrotizing enterocolitis - a common and often fatal infection in Uganda, Rwanda and Kenya.

Weibel said "We get many of the beneficial microbes that take up residence in our bodies from our mothers at birth. But if there are pathogens that are transmitted from mother to baby as well, they can be identified and treated."

Treating those pathogens often means administering an antibiotic after the infant has developed vague symptoms. As the mother nears labor, she may be given antibiotics as a preventive measure - the problem is that the antibiotic itself causes the very problem it was designed to prevent.

Weibel said "An approach like that can indiscriminately destroy almost all of the bacteria in a baby's intestines - including the helpful types -leaving harmful bacteria the space and resources to flourish. And you're back where you don't want to be, working against a high mortality rate."

By knowing whether harmful bacteria are present before or after birth, antibiotic usage can be narrowed down to just those who really need it. However, verifying who the needy ones are has meant, until now, using complex and expensive genome sequencing equipment that only exists in well funded laboratories.

Wiebel's group configured the cartridge system and managed to keep the cost per unit below one dollar.

Wiebel said "Nate Cira, a really smart undergrad who worked in our lab, developed a small cartridge that we have adapted to carry almost everything needed to identify harmful microbes. It is extraordinarily simple. It doesn't require someone that has a lot of clinical microbiology expertise."

The team plans to adapt the technology so that it can be used with smartphones and the results may be processed and shared through a wireless connection. The analysis data could be shared with health care providers nearby and centers that monitor disease globally. Weibel said "The doctor gets information on the specific organism that could cause very serious health problems for a baby, and disease centers can use it for epidemiological research."

The Grand Challenges Explorations has funded over 80 projects, at $100,000 each for one year's research. They all have to option of then submitting their work for further funding, which may be up to $1 million.

Chris Wilson, director of the Global Health Discovery and Translational Sciences program at the Gates Foundation, said "Investments in innovative global health research are already paying off. We continue to be impressed by the novelty and innovative spirit of Grand Challenges Explorations projects and are enthusiastic about this exciting research. These investments hold real potential to yield new solutions to improve the health of millions of people in the developing world, and ensure that everyone has the chance to live a healthy, productive life."

Weibel will visit Uganda with James Ntambi, a fellow biochemistry professor, as well as a group of UW-Madison students. They will set up a lab where they can test the cartridges.

Invisible Sentinel Awarded AOAC Approval for Its Veriflow™ Campylobacter Assay

Invisible Sentinel Inc., a life sciences company that develops rapid diagnostics for the detection of foodborne pathogens, announced today that its first-in-class rapid diagnostic for the detection of Campylobacter jejuni and Campylobacter coli in poultry received Performance Tested Methods(SM) accreditation from the Association of Analytical Communities (AOAC). The AOAC is a global standardization organization that validates analytical test methods for the food industry. The AOAC Performance Tested Methods(SM) designation is recognized by the USDA and FDA, as well as numerous global regulatory agencies.

"This approval marks a tremendous milestone for Invisible Sentinel and introduces our first-in-class pathogen detection system to the food industry. The Company's Veriflow(TM) Campylobacter Assay (Veriflow(TM) CA) is a rapid, molecular based detection system designed to provide easy-to-interpret results," said Ben Pascal, co-founder and CEO of Invisible Sentinel.

Invisible Sentinel's Veriflow(TM) CA is a unique molecular detection system and is the first hand-held molecular diagnostic to be approved by the AOAC for the detection of foodborne pathogens. This test is among the fastest commercially available assays for the detection of Campylobacter from poultry rinsates and offers a multitude of competitive advantages over alternative detection methods. The Veriflow(TM) system features the robustness, ease of use, and speed of detection that was previously absent from competing testing methodologies.

"We are now providing Veriflow(TM) CA to targeted customers and are initiating discussions with potential partners for its further distribution in the United States, Europe and other territories," said Nick Siciliano, co-founder and COO of Invisible Sentinel. "Veriflow(TM) CA is an excellent demonstration of Invisible Sentinel's technology and we are advancing Veriflow(TM) assays for the detection of Listeria, Salmonella, and Shiga toxin-producing E. coli (STEC) through the AOAC approval process. We intend to provide a comprehensive suite of pathogen detection solutions to the food industry," said Siciliano.

Invisible Sentinel has commenced manufacturing of its Veriflow(TM) assays and is preparing for a formal product launch. The Company believes their Veriflow(TM) technology will create a paradigm shift in the food industry by providing a diagnostic solution that combines the practicality and versatility of traditional methods with the speed and sensitivity of molecular based detection.

Monday, November 05, 2012

Assay Identifies Lethal Clostridium difficile Pathogen

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), has announced that it obtained CE Marking of the BD MAX™ Cdiff Assay. The assay detects the toxin B gene (tcdB), which has been shown to be present in all toxigenic C. difficile and is essential for disease.

Run on the fully automated BD MAX™ System, the assay is designed to rapidly and accurately identify patients with Clostridium difficile infection (CDI), including those caused by hypervirulent strains. Rapidly and accurately identifying these patients enables appropriate treatment and infection control measures to be implemented quickly, which may improve patient outcomes.

"As CDI rates continue to increase in healthcare facilities worldwide, rapid molecular testing for detection of toxigenic C. difficile can help expedite appropriate treatment, reduce length of stay, and improve patient outcomes," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "The BD MAX Cdiff Assay launch is another important milestone in our effort to deliver a range of clinical tests on the BD MAX System, offering laboratories improved efficiency, turnaround time, and productivity."

According to a recent study in the American Journal of Infection Control, nucleic acid amplification tests provide better sensitivity over enzyme immunoassay and glutamate dehydrogenase testing algorithms for detection of toxigenic C. difficile. C. difficile is a gram-positive bacterium that is responsible for the development of antibiotic-associated diarrhoea and colitis that can progress to toxic megacolon, sepsis and death. More than 95% of antibiotic-associated pseudomembranous colitis cases are caused by CDIs, resulting in more than $1 billion in healthcare costs annually.

Tiruchi Health Officials Seize Dengue Rapid Card Test Kits

Health officials of the Tiruchi Corporation seized dengue rapid card test kits from diagnostic laboratories of three hospitals in the city.

The seizures were made during surprise inspections conducted by the officials led by Corporation Commissioner V.P.Thandapani at the Vasan Hospital at Puthur, Deepan Hospital and Gitanjali Hospital in the city. The move comes in the wake of reports of rising cases of dengue over the past week in the city.

According to the officials, the government has advised hospitals and laboratories not to conduct rapid card tests for the time being as only ELISA test could confirm dengue. However, some hospitals were found to be carrying out the rapid test, spreading panic.

Sources said that the hospital staff informed the officials that they have stopped conducting the rapid tests . Nevertheless, the officials seized the kits. The hospital authorities were also cautioned that closure notices would be issued if they continued to conduct the rapid test.

Dr.Senthil Kumar, City Health Officer (in-charge), and other health officers were present.

Mr.Thandapani told The Hindu that the rapid test was only an indicative one and there were three approved labs in the city conducting ELISA test, including the Mahatma Gandhi Government Hospital, the Public Health Department’s lab at the office of the Senior Entomologist, and Doctor’s Diagnostics, a private lab.

The Commissioner also affirmed that the Corporation was continuing its awareness measures against dengue, and mosquito breeding sources at households were being removed.

HiberGene Diagnostics Appoints New CEO

HiberGene Diagnostics, a diagnostics company utilising the latest medical technology to develop, market and manufacture molecular diagnostic tests for human infectious diseases, has announced the appointment of Tony Hill as chief executive officer.

HiberGene is based at NovaUCD, the Centre for New Ventures and Entrepreneurs at University College Dublin.

Hill joins HiberGene from Innogenetics, an international diagnostics company, where he was global sales director. Prior to this, Hill was vice-president at OraSure Technologies, and earlier roles included a number of positions at Sigma Aldrich.

Hill has a wealth of experience from more than 20 years in the diagnostic and life science industries. He brings with him expertise in general management and marketing and sales, coupled with a strong track record in growing domestic and international markets.

Brendan Farrell, executive chairman of HiberGene, said: "I am delighted to have secured someone of Tony's calibre to lead HiberGene. He has a great range of experience across diagnostics and life sciences, coupled with a strong track record of success."

Hill added: "This is a very exciting time to be joining HiberGene. The company has developed an excellent test for meningitis using a very innovative platform, which fills a significant unmet clinical need."

HiberGene has developed a molecular diagnostic test for meningococcus and plans also to develop a test for pneumococcal meningitis, the two most common forms of meningitis. Using a novel rapid amplification platform, HiberGene has produced a rapid and highly sensitive diagnostic test which can be used in almost any clinical or laboratory setting.

The company is currently fundraising to progress the tests for meningitis through to commercialisation and to fund further ongoing research and development on a complementary range of human infectious diseases.

Nanosphere's Bloodstream Infection Test Designated Moderate Complexity by FDA

Nanosphere, Inc., a leader in the development and commercialization of advanced molecular diagnostics systems, announced that it received notice from the U.S. Food and Drug Administration (FDA) that its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the Verigene® System has been categorized as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity. This categorization of the BC-GP test underscores the ease of use of the Verigene System and supports the decentralization of molecular testing.

"Decentralization of diagnostic tests that provide critical patient care information is of paramount importance in achieving improved outcomes and lower cost of care," said Nanosphere CEO Bill Moffitt. "We are committed to supporting our customers' needs as we expand our test menu and strive for flexible platform functionality. Our Verigene System has again achieved a notable milestone in that regard."

Nanosphere's BC-GP test is run on the Verigene System, an easy-to-use cartridge-based platform that enables rapid multiplex testing with sample-to-result automation in a near-patient setting. The Verigene BC-GP test provides genus and species level detection for a broad panel of clinically significant Gram-positive bacteria. In addition, the BC-GP test detects the mecA, vanA, and vanB genes that identify resistance to the antibiotics methicillin/oxacillin and vancomycin.

Accurately identifying bacteria and resistance markers in a timely manner is crucial for guiding appropriate antibiotic therapy. Clinical studies have shown that faster results enable better patient outcomes and significant cost savings. Studies reveal the delay in administration of appropriate antibiotics is associated with a 7.6% decrease in survival rate for each hour treatment is delayed.1 Rapid molecular testing of blood cultures has been shown to reduce this time and leads to a hospital cost savings of up to $21,000 per patient.2 While current microbiological culture techniques take 24-48 hours to identify bacterial pathogens and determine their resistance or susceptibility to common antibiotics, the Verigene BC-GP test produces results in two and a half hours with less than 5 minutes hands-on time.

The BC-GP test is part of a growing menu of infectious disease assays for use on the Verigene System. The Respiratory Virus Plus Nucleic Acid Test (RV+) is a FDA-cleared CLIA moderate-complexity in vitro diagnostic test for the detection of multiple respiratory viruses and virus subtypes. A sample-to-result test for C. difficile is pending 510(k) review by the FDA, while tests for Gram-negative blood cultures and enteric bacteria and viruses are currently in development.

Thursday, November 01, 2012

The New TECHLAB Shiga Toxin E. coli Rapid Test Receives FDA Clearance

Alere Inc., a global leader in rapid diagnostics and health management, has announced U.S. Food and Drug Administration (FDA) clearance for the TECHLAB® SHIGA TOXIN QUIK CHEK test for the U.S. market.

SHIGA TOXIN QUIK CHEK is the only rapid diagnostic available that can detect Shiga toxin-producing E. coli (STEC), which can have fatal effects, directly from a stool specimen. The test offers significant advantages over other rapid cassette assays in that it removes the need for overnight bacterial culture preparation. The SHIGA TOXIN QUIK CHEK provides results up to 24 hours before other rapid tests, enabling clinicians to initiate patient care sooner and minimize the potential for broader bacterial outbreaks. The test’s considerably shorter sample preparation process also helps to dramatically streamline laboratory workflows.

“The recent FDA clearance of our new Shiga Toxin E. coli test enhances Alere’s position as a market leader for enteric disease diagnostics and is a testament to our strong partnership with TECHLAB®, Inc.,” said Jim Post, President of Alere North America. “By narrowing the diagnostic window from a day to 30 minutes, the SHIGA TOXIN QUIK CHEK promises to be a significant help to clinicians, facilitating more rapid patient care that leads to better outcomes, improving workflows, and reducing the potential for broader outbreaks.”

Shiga toxin-producing E. coli are commonly associated with food- and water-borne outbreaks of diarrheal illness. Shiga Toxin 1 and Shiga Toxin 2, produced singly or in combination by more than 200 different strains of STEC, are the enterohemorrhagic toxins that cause disease. O157 is the most well known strain and has been responsible for numerous outbreaks in the past. Several other strains, though, have led to severe outbreaks, and SHIGA TOXIN QUIK CHEK detects toxins from both O157 and non-O157 strains. If left untreated, STEC infections can lead to severe complications such as hemolytic uremic syndrome (HUS), an often fatal condition characterized by renal failure and hemolytic anemia. Rapid identification of STEC is vital to help prevent complications like HUS.

The SHIGA TOXIN QUIK CHEK is the newest addition to the Alere Enterics suite of QUIK CHEK assays developed and manufactured by TECHLAB®, Inc. It combines the precise accuracy of an enzyme immunoassay with the speed and ease of use of a cassette. The SHIGA TOXIN QUIK CHEK requires few processing steps and provides differentiated results for Shiga Toxin 1 and 2 within 30 minutes of sample receipt, allowing for rapid diagnosis and prompt initiation of patient treatment. In addition to being cleared for use in the United States, the SHIGA TOXIN QUIK CHEK has received CE marking and available in other worldwide markets.

FAMU Professor Awarded U.S. Patent to Identify Bacteria Stains

Marlon S. Thomas, bioengineer and professor in Florida A&M University’s (FAMU) College of Agriculture and Food Sciences, was awarded United States Patent No. 8,252,522 for his research development in species detection methods and systems.

Bacterial infections continue to be one of the major health risks in this country and timing in successfully diagnosing life-threatening ailments contributes to the high cost of health care and patient mortality.

Thomas, after six years of research, has invented a new method to quickly identify bacteria stains by using chemical dyes and fluorescent assays. The patent is a significant breakthrough to better monitor health conditions through providing methods, systems and kits for cellular and sub cellular identification in a rapid, throughput manner.

Thomas explained the significance and impact of the new patent on the medical profession.

“The goal in any health care emergency, such as food poisoning and contamination, is to quickly identify the root of the problem at hand in order to diagnosis the best remedy,” said Thomas. “The patent holds the potential to provide the means to better manage chronic diseases for physicians and health care professionals. The new staining method will someday in the near future impact the general public with point of care detection that can be used in the privacy of the home.”

His patent method requires no equipment or electricity, which makes it easier to incorporate into the current process of bacterial identification.

His work was a part of his dissertation at the University of California in Riverside, Calif. where he earned his Ph.D. Thomas is hopeful that the patent will be adopted into an assay and brought into the standing procedures of bacterial identification as what is called an “add on” to the standard method which was developed by Hans Christian Gram nearly 130 years ago.

Thomas credits Valentine I. Vullev, who served as his Ph.D. advisor, and Elizabeth R. Zielins, who was one of his undergraduate students at the University of California at Riverside, for assisting him with this patent.

Since receiving the patent, Thomas has continued his research and is working on two additional patents for new tools that will also help manage chronic diseases. His research combines his interest in microfluidics, biophotonics, surface chemistry and bioengineering.

Robert Taylor, dean and director of Land-Grant Programs in CAFS expressed, “This is the epitome of the land-grant concept under which FAMU was established! Faculty train students through academic study and scientific discoveries made to change life for the better for all. We are very proud of this significant accomplishment made by one of FAMU’s own.”

New Molecular Assay Detects Rapidly Emerging Multidrug-Resistant Superbug

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced the release of a research use only (RUO) molecular test designed to rapidly detect antibiotic resistance genes found in the superbug known as carbapenem-resistant Enterobacteriaceae (CRE). These deadly organisms are associated with high mortality rates, are easily spread from patient-to-patient and are resistant to nearly all antibiotics. In some cases there are no treatments that are effective against infections caused by CRE.

Rapid identification is critical to allow proper treatment and isolation of patients to prevent its spread. The assay, performed on the fully-automated BD MAX™System, is designed to detect carbapenem resistance genes and produces results in just two hours. Conventional culture methods take several days to report results. BD is making the assay available, for research use only, to a limited number of infectious disease experts and researchers to gather feedback on its performance.

"BD has a strong scientific commitment to developing innovative diagnostics in response to the challenge of emerging pathogens," said Patrick Murray, Ph.D., Worldwide Director of Scientific Affairs, BD Diagnostics - Diagnostic Systems. "We are offering this assay initially as a research tool to help BD and infectious disease researchers explore its clinical utility while we pursue development of an in vitro diagnostic solution." The RUO assay is not for in vitro diagnostic (IVD) use.

Incidence of carbapenem-resistant organisms has increased dramatically over the past decade. The most concerning are CRE that have acquired carbapenemase genes including KPC, NDM, and OXA-48. The BD MAX assay is the first fully-automated assay to detect all three of these genes directly from specimens. In 2011, KPC strains were reported in 37 U.S. states. NDM strains, first discovered in 2008, have spread worldwide, while OXA-48 is now found throughout Europe, Northern Africa and India.

"Multiple antibiotic-resistant bacteria, including carbapenemase-producing strains, have emerged worldwide at an alarming rate and now routinely cause both community- and hospital-acquired infections," said Dr. Brian Currie, Vice President and Medical Director for Research at Montefiore Medical Center and Assistant Dean for Clinical Research at the Albert Einstein College of Medicine. "The medical community urgently needs more rapid and accurate methods to detect carbapenemase-producing bacteria in order to prevent the further spread of these deadly organisms."

Assays already available on the BD MAX System to address healthcare-associated infections include methicillin-resistant Staphylococcus aureus (MRSA) and toxigenic Clostridium difficile, both CE-marked for IVD use in Europe. The BD MAX MRSA assay was FDA-cleared with CLIA Moderate Complexity categorization earlier this year. The toxigenic Clostridium difficile assay has been submitted to the FDA for 510(k) review and clearance.