Tuesday, March 27, 2012

Invisible Sentinel Announces Allowance of Additional U.S. Patent Application for Rapid Diagnostic Technology to Detect Harmful Pathogens in Food

Invisible Sentinel Inc., a life sciences company that develops rapid diagnostics for the detection of foodborne pathogens, announced today it has been issued a notice of allowance for U.S. Patent application 13/221,116, “Device for Detection of Target Molecules and Uses Thereof.” Once issued, this will be the second U.S. patent for Invisible Sentinel and will serve to further strengthen the Company’s intellectual property position. This application provides additional protection for Invisible Sentinel’s proprietary diagnostic device capable of rapid and selective identification of pathogenic bacteria from contaminated food samples. The Company also has additional patent applications pending both in the United States and abroad..

“The allowance of this patent application is a valuable addition to our Company’s growing intellectual property portfolio,” said Benjamin Pascal, CEO and co-founder of Invisible Sentinel. “Our expanding patent portfolio comes at an opportune time, when new government regulations and enhanced consumer awareness are leading to a significant increase in food pathogen testing throughout the industry. We are currently preparing for regulatory submissions and anticipate commercializing our technology later this year.“.

Invisible Sentinel’s diagnostic system provides a robust, sensitive, reproducible, and easy-to-interpret assay. The Company’s internally developed technology is designed to address the growing need for rapid, practical, and cost-efficient detection methods for foodborne pathogens at the point of care. “We anticipate our products to be an important step forward in enabling food processors and third party laboratories to perform practical yet sophisticated testing for pathogen contamination from farm to fork,” said Pascal. The food industry is the first market that the Company is targeting, but its patented and patent pending technology has the potential to provide valuable tools for additional industries including healthcare, veterinary, biodefense, and environmental testing, where rapid detection of target analytes from unrefined samples is critical.

IntelligentMDx to Present Development of Two CE-Marked Assays at 22nd Annual European Congress of Clinical Microbiology and Infectious Diseases

IntelligentMDx (IMDx), a molecular diagnostic company that uses a proprietary bioinformatics platform that accelerates the development of PCR-based diagnostic testing solutions, will be presenting three posters at the 22nd annual European Congress of Clinical Microbiology and Infectious Diseases Meeting (ECCMID). The ECCMID meeting on March 31 - April 3, 2012 in London, UK, attracts more than 7,000 participants with expertise in infectious disease areas, including emerging infections, diagnosis, prevention, and treatment.

IMDx has designed, developed, and manufactured two CE-marked assays in the past year under a multi-year distribution agreement with Abbott. One CE-marked assay provides rapid and sensitive detection of toxigenic Clostridium difficile, while the second CE-marked assay provides for the detection of Vancomycin-resistant Enterococci. A third assay will be CE-marked later this year for the detection of Group B streptococcus. All three assays have been designed and validated to run on the Abbott m2000™ system, for fully automated, high-throughput diagnosis of these infectious diseases. The IMDx pipeline includes assays for detection of Herpes Simplex Virus 1 and 2, Influenza A/B and RSV, Epstein-Barr virus, BK virus, and additional assays targeting oncology, human genetics and companion diagnostics.

The three posters presented by Dr. Heinz Reiske, Manager of Research and Development at IMDx, will detail the technology used to develop the IMDx assays and present performance characteristics for each assay.

Sunday, April 01, 2012, Poster Session III, 13:30 - 14:30, Spot P1381
Development of a high-throughput, rapid and sensitive molecular assay on the Abbott m2000 for detection of group B Streptococcus in antepartum and intrapartum women. H. Reiske*, C. Leslin, R. Kowal, A. Jacobs, R. Del Mastro (Cambridge, Des Plaines, US)

Monday, April 02, 2012, Poster Session IV, 12:30 - 13:30, Spot P1659
A CE-marked automated molecular test on the Abbott m2000 for the detection of vancomycin resistance genes vanA and vanB most commonly found in vancomycin-resistant enterococci. H. Reiske*, C. Leslin, R. Kowal, A. Jacobs, R. Del Mastro (Cambridge, Des Plaines, US)

Tuesday, April 03, 2012, Poster Session VI, 12:30 - 13:30, P 2268
A CE-marked DNA molecular assay on the Abbott m2000 for the detection of toxigenic and hypervirulent strains of C. difficile. H. Reiske*, C. Leslin, R. Kowal, A. Jacobs, R. Del Mastro (Cambridge, Des Plaines, US)

Monday, March 26, 2012

Bruker Daltonics to Exhibit at the 2012 PDA Annual Meeting in Phoenix, Arizona

Bruker Daltonics Inc.
40 Manning Road
Billerica, MA 01821
phone: +1 (978) 663-3660
fax: +1 (978) 667-5993
email: ms-sales@bdal.com
website: http://www.maldibiotyper.com

Bruker Daltonics will be presenting the latest developments in its MALDI Biotyper for microbial identification based on MALDI TOF mass spectrometry, at the Parenteral Drug Association (PDA) annual meeting to be held from April 16th to 18th in Phoenix, AZ (for more information on the meeting, see: http://pdaannualmeeting.org/).

The MALDI Biotyper applies MALDI-TOF mass spectrometry to make QC microbiology faster, better and more cost effective. Please visit our booth in the exhibit hall to meet our experts and learn how MALDI Biotyper can improve your workflows; our booth number is 311.

We also invite you to join us on Monday evening, April 16th, at a special dinner event beginning at 7:00 pm at the JW Marriott Desert Ridge Resort, in Desert Suite IV and VI. The program begins with a reception and drinks from 7:00 to 7:30, followed by a dinner featuring the following speakers:

Ebony Scales, QC Scientist II, Pfizer: “Evaluation of a MALDI Biotyper Microbial Identification System”
Amy McDaniel, Ph. D, Associate Director, Production Operations, Pfizer: “Validation of a MALDI Biotyper for routine microbial identifications in a QC Microbiology Laboratory”

Seating is limited and registration is required, so please register today at:

Saturday, March 24, 2012

On World TB Day Project HOPE Hails Promise Of New Diagnosis Technology

On World TB Day, global NGO Project HOPE says new technology has the potential to revolutionize the speedy and accurate diagnosis of tuberculosis, one of the deadliest public health threats which claims about six million lives each year.

About one-third of the world’s population is infected with Mycobacterium tuberculosis (MTb), the bacterium that causes TB. Tuberculosis is spread from person to person through the air as the bacteria may be passed on through coughing, sneezing, talking or laughing.

But now, the GeneXpert®, a cartridge-based, automated, real-time molecular diagnostic test can identify Mycobacterium tuberculosis (MTB) and resistance to rifampicin (RIF) simultaneously in about 100 minutes. In addition to providing rapid diagnosis of TB, operating the GeneXpert® does not require a high level laboratory with stringent bio-safety standards, which allows this technology to be introduced closer to the populations that need it. The World Health Organization (WHO) has endorsed the technology for use in TB endemic countries, declaring it a major milestone for global TB diagnosis.

Project HOPE, a global health education and humanitarian assistance organization, has been using the GeneXpert® machines in field offices in southern Malawi since October 2011. The program, supported by USAID, has eight GeneXpert® machines currently in operation in the rural districts of Mulanje, Phalombe, Balaka, Mangochi, Zomba and Chikhwawa – an area that accounts for 21 percent of the country’s total population and 18 percent of Malawi’s known TB cases.

“This technology represents a major breakthrough in TB diagnostics in the public sector. We need to have this technology at the primary care level – on the frontlines of the battle to eradicate TB,” said Steve Neri, Project HOPE’s regional director for Africa.

Educating communities about tuberculosis detection and TB/HIV co-infection is equally crucial, says Neri.

“There’s still a stigma associated with TB and HIV. There needs to be more information and counseling available at the community level so people will know that if you’re getting tested for TB, you should also get tested for HIV. We need to empower individuals to demand the services that will save their lives,” said Neri.

HOPE’s efforts in Malawi have yielded positive results in preventing the spread of TB, a major cause of death and sickness, especially for people with HIV/AIDS.

Project HOPE initiated a five-year program in 2006 in Malawi’s Mulanje and Phalombe districts to support the National TB Program and improve TB case management and treatment outcomes. Project HOPE-trained volunteers made regular trips from their villages, on foot or on bike, carrying TB test samples to TB diagnostic centers miles away – and the results are formidable.

The TB treatment success rate in the districts increased from 60 percent to 86 percent in the five year period, surpassing the WHO’s target rate of 85 percent, and mortality rates decreased to 11 per cent from 20 percent.

In Central Asia, Project HOPE is introducing GeneXpert® technology as a catalyst for improved care at a clinical level in the future.

“GeneXpert®, in addition to improving case detection and rapid identification of Multi-Drug Resistant (MDR) TB cases, will be used to trigger change in practices and to move systems towards ambulatory care,” said Tom Mohr, Regional TB Manager for Project HOPE in Central Asia.

The GeneXpert® System is manufactured by Cepheid, a leading molecular diagnostics company based in Sunnyvale, California.

World TB Day is an annual global event on March 24 that aims to raise public awareness of tuberculosis and the efforts made to prevent and treat the disease.

About Project HOPE

Founded in 1958, Project HOPE (Health Opportunities for People Everywhere) is dedicated to providing lasting solutions to health problems, with the mission of helping people to help themselves. Identifiable to many by the SS HOPE, the world’s first peacetime hospital ship, Project HOPE now conducts land-based medical training and health education programs in more than 35 countries across five continents.

Thursday, March 22, 2012

MOgene LC Signs Agreement With Lawrence Livermore National Lab to Offer Microbial Detection Array Services

MOgene, LC, a leading NimbleGen Service provider based in St. Louis, MO, has announced the signing of an agreement with Lawrence Livermore National Laboratory (LLNL) to provide services using the Lawrence Livermore Microbial Detection Array (LLMDA).

The technology of the LLMDA, which includes probes for more than 3,000 bacterial and viral species, has been optimized for NimbleGen arrays. The Livermore-developed array provides rapid and comprehensive analysis of bacteria or viruses from biological material of unknown nature.

This capability has been shown to be very useful in food and pharmaceutical safety, detection of viral and bacterial infections, and animal health, as well as many other applications.

"We signed an agreement with LLNL for the potential it offers to our existing customers and because it allows us to expand into new areas for our microarray and sequencing service business," said Shaukat Rangwala, senior vice-president of MOgene.

The LLMDA could enable food safety professionals, law enforcement, medical professionals and others to detect within 24 hours any virus or bacteria that has been sequenced and included among the array's probes. It detects viruses and bacteria with the use of 388,000 probes that fit in a checkerboard pattern in the middle of a one-inch wide, three-inch long glass slide.

One advantage of the LLMDA is that it provides researchers with the capability of detecting pathogens over the entire range of known viruses and bacteria. Current multiplex polymerase chain reaction (PCR) techniques can at most offer detection from among 50 organisms in one test.

MOgene has been in the genomics service business since 2004 and has worked with many pharmaceutical and agricultural businesses, along with universities, around the world.

"We believe that adding this technology to our offerings brings added value to our existing and new customers," Rangwala concluded.

About MOgene, LC MOgene is a leading global genomics service provider located in St. Louis, Missouri. MOgene offers a full range of genomic services from RNA/DNA isolation, microarrays, real-time PCR, NGS to complete analysis. The company is a long time Agilent-certified and NimbleGen service provider for gene expression, CGH, ChIP, miRNA and methylation microarrays. In the area of bioinformatics, the company works with its customers to provide customized solutions and publication-ready analysis.

About LLNL Founded in 1952, Lawrence Livermore National Laboratory is a national security laboratory that develops science and engineering technology and provides innovative solutions to our nation's most important challenges. Lawrence Livermore National Laboratory is managed by Lawrence Livermore National Security, LLC for the U.S. Department of Energy's National Nuclear Security Administration.

Wednesday, March 21, 2012

AdvanDx to Unveil QuickFISH™ (20 Min. Pathogen ID) at ECCMID 2012

AdvanDx today announced that it will unveil its new QuickFISH™ rapid pathogen tests at the European Congress for Clinical Microbiology and Infectious Diseases in London, United Kingdom (March 31st to April 3rd). The new tests mark a significant advance in speed to results and ease-of-use that will help clinical microbiologist and infectious diseases clinicians optimize antibiotic therapy and care much earlier for patients with bloodstream infections (a.k.a septicemia). In addition, 7 studies will be presented documenting both the high performance of QuickFISH tests and the clinical utility of rapid bloodstream pathogen identification.

QuickFISH is a brand new, rapid, molecular diagnostic platform developed by AdvanDx based on proprietary PNA probe technology. The new platform enables very fast (20 minutes) identification of bacteria directly from such complex samples as positive blood cultures. The speed and ease-of-use will for the first time enable clinical microbiologist to obtain pathogen results, such as S. aureus, E. faecium, P. aeruginosa and Candida species, in time to report with the Gram stain critical values call for positive blood cultures. This, in turn, will help clinicians base therapy selection on more specific information at a critical antibiotic decision point for patients with bloodstream infections. Features include:
  • 20 Min. Turn-around Time – Fast enough to be reported with Gram stain results.
  • 5 Min. Hands-on Time – Simplifies and streamlines laboratory workflow.
  • Built-in, Universal Controls – Ensures confidence in every test result.
  • Limited Instrumentation Required – Easy and inexpensive to implement and start testing.
To learn more, visit booth # 535 while attending ECCMID 2012 in London.

Roka Bioscience Awarded AOAC-RI Certification for Atlas™ Salmonella Detection Assay

Roka Bioscience announced today that their Atlas Salmonella Detection Assay has received AOAC Performance Tested Methods certification from the AOAC Research Institute (AOAC-RI). The independent laboratory study was conducted by Silliker, Inc., as part of the AOAC-RI independent third-party validation process. The Atlas Salmonella Detection Assay runs on the Atlas System, an innovative fully automated molecular instrument for the detection of pathogens in food and environmental samples. This instrument utilizes a simple three-step procedure--Enrich, Transfer, Automate--and is capable of processing over 300 samples in 8 hours. The system's continuous workflow and high throughput provides greater efficiency, flexibility, and dynamic scalability to meet the ever-increasing demands placed on food safety laboratories. Customer evaluations have demonstrated a reduction in direct labor costs with the Atlas System in side-by-side comparisons with leading competitive methods.

The initial menu for the Atlas System includes the Atlas Salmonella Detection Assay and the Atlas Listeria Detection Assay, which received AOAC-RI certification in January 2012. Additional assays are currently in development.

"AOAC-RI certification involves rigorous independent testing and reviews and is a critical performance-based validation," states Paul Thomas, CEO and President of Roka Bioscience. "Adding the Atlas Salmonella Assay to our menu of AOAC-RI-approved assays underscores our commitment to making the Atlas System and Atlas Detection Assays the ideal testing solution for food safety laboratories."

About AOAC-RIThe AOAC Research Institute (AOAC-RI) is a wholly owned subsidiary of AOAC INTERNATIONAL (AOAC) that administers AOAC's conformity assessment, including the AOAC Performance Tested Methods program. AOAC is a globally recognized, independent, not-for-profit standards developing association founded in 1884. AOAC serves the analytical community by engaging industry stakeholders to develop voluntary consensus standards for methods and providing analytical methods that demonstrate confidence in analytical results.

Roka BioscienceRoka Bioscience is a privately held company focused on developing and commercializing innovative solutions based on molecular technologies for the industrial markets. The company's scientific platform is based on proven, proprietary technologies used widely in clinical diagnostic testing and now being introduced into food safety and other industrial markets. Roka's current product line provides food safety professionals with a fully automated molecular pathogen detection solution that delivers rapid, accurate results and improved laboratory efficiencies.

Firefly Technology Sheds Light on Food Safety

Food contamination can now be detected easily by a new device based on the chemical which lights up fireflies.

The Bioluminescent Assay in Real-Time (BART), jointly invented by Professor Jim Murray of Cardiff University and Dr. Laurence Tisi of Lumora, allows users to test rapidly and simply for food poisoning bacteria. Professor Murray and his partners at technology company Lumora Ltd hope to develop the system to test for other diseases, including HIV-AIDS.

The BART system detects specific DNA sequences by producing a light signal, using a version of the enzyme luciferase, which also produces light in fireflies. The breakthrough allows for quick and easy molecular testing which previously required complex laboratory hardware.

Professor Murray and Dr Tisi have just been selected as Finalists for the "Innovator of the Year" award run by the Biotechnology and Biological Sciences Research Council.

The first BART system has been created for food safety testing. Samples are placed inside a remarkably simple device, which can then test for the DNA of common food pathogens. If present, the bacteria trigger the luciferase to produce light. The device can produce results in ten minutes to an hour, depending on the number of organisms being tested for.

Professor Murray, of the Universitys School of Biosciences, said: "The food industry has been looking for dependable, fast and convenient microbiological testing for a long time. Our system will allow workers to test a wide variety of foods in a simple system which uses the most sensitive molecular technology. Portable versions of the device mean that its now even possible to test farm animals in the food chain.

"We now want to apply BART technology to a range of other diseases. The most obvious and most pressing need is HIV-AIDS. Patients need to be continuously tested for their viral loads so that their treatment dosage can be adjusted. At the moment, this requires laboratory facilities which are in short supply in Africa. We hope to create a device which can be used easily in those countries."

Lumora is a spin-out company based on Professor Murrays research which now employs 13 people in Cambridgeshire.

The results of the BBSRC Innovator of the Year Award will be announced on Wednesday, March 28.

Tuesday, March 20, 2012

Developing Rapid Dengue Test Kit

Since the start of the year, no dengue outbreak and no clustering of cases in any part of the country have been reported, largely due to the intensified efforts to curb the disease. The public is constantly reminded to take precautions against mosquitoes by following the 4-S strategy of the Department of Health (DoH): Search and destroy, Self-protection, Seek early treatment, and Say no to indiscriminate fogging.

Scientists from the Institute of Molecular Biology-National Institute of Health of the University of the Philippines-Manila have developed an inexpensive rapid test kit for dengue which is being pilot-tested in three hospitals in Metro Manila – Rizal Medical Center, National Children’s Hospital, and Philippine Children’s Medical Center. Clinical validation of the research is in process, as part of regulatory compliance before commercial release, and it is showing “promising results,” say project proponents. The one-step dengue test is expected to translate to better delivery of healthcare s it will enable doctors to diagnose, in just one hour, dengue at the onset of fever. Dengue is currently diagnosed within five to seven days after the onset of fever. Development of the rapid dengue test kit is funded by the Philippine Council for Health Research and Development as part of government’s anti-dengue program.

Clinical tests for the first vaccine for dengue are also now being done and the new vaccine may be ready by 2014. Health officials assure that the new vaccine is safe, but more tests are being conducted to determine side effects.

Dengue continues to be a major public health concern. It is prevalent in tropical countries like the Philippines. The way to prevent it is to control mosquito populations through eliminating breeding sites. The dengue-carrier, a black with white spots mosquito called Aedes Aegypti, breeds in stagnant water. Clothing, mosquito repellent, and netting can help reduce exposure. Appropriate medical care can save lives. Anyone can fall ill with dengue anytime during the year but the number of patients increases during the rainy season. From January 1 to February 4 this year, DoH records show that there are 1,753 cases; the National Capital Region had the biggest number of cases – 118.

Dengue fever is fatal but can be treated and prevented, with early detection and prompt treatment. The rapid test kit as well as the vaccine being tested could boost the campaign to decrease dengue mortality. The coordinated action by government agencies can also help curb the spread of the disease.

XCyton Gets $4.5 mn From Fidelity to Launch Novel Diagnostic Platform ‘SES’ for Critical Infections

XCyton Diagnostics has received a fund infusion of US$ 4.5 million from Fidelity Capital Advisors to develop a molecular diagnostic platform for critical infections ‘Syndrome Evaluation System’ (SES) which is a single test for the simultaneous detection of all the probable causative agents which cause a group of symptoms in patients.

The diagnostic tool will now transform the critical care therapeutic decision support. It will help the doctors make an informed diagnosis within 7 hours with just one test. SES can accurately and immediately identify multiple organisms inclusive of bacteria, viruses, fungi and parasites via specific test from a single sample. The process provides clinical with a quick, definitive assessment of a patient who is presenting a set of symptoms common to multiple pathogens.

“We have revolutionized Critical Care management through a paradigm shift: from disease-based sequential diagnosis of one aetiological agent after the other to a syndrome-based assessment which detects simultaneously multiple pathogens in a single test in a single clinical specimen. This is developed with a sole purpose of empowering physicians to make evidence based critical care therapeutic decisions. The clinical assessment of SES over the last 2 years has proved that it has been able to save 80- 90 per cent of the cases. The physicians have also been able to administer the specific antibiotics to control the condition,” stated Dr BV Ravi Kumar, founder chairman and managing director, XCyton Diagnostics.

The test replaces the conventional microbiological cultures and is a quantum jump in terms of specificity. The technologies currently available are inadequate and delayed diagnosis leading to critical illnesses. This is resulting in loss of function of the infections resulting in permanent blindness or brain infections causing paralysis or septicemia reporting around 3 million fatal cases, he added.

According to Kiran Mazumdar- Shaw, head, Vision Group on Biotechnology, government of Karnataka and CMD Biocon, said that SES is a differential platform that will provide novel ways to rapidly diagnose critical care infections and provide superior outcomes. It is an approach to personalized medicine and is a significant milestone in molecular diagnostics.

The technology has four patents including eye infection related blindness, and septicemia. The product is cost-effective as it reduces the overall expenses of multiple tests, reduces ICU stay. “Right now we are offering it as a service for a fee which varies between Rs.6,000 to 20,000.

Experts have also stated that currently there is no such diagnostic tool made available globally although international companies have been working on the same. This makes XCyton the first in the world to come out with a comprehensive diagnostic technology.

In the last decade, the company had developed immunodiagnostic kits for the detection of Infection. It is credited with the development of the first indigenous ELISA kit for the detection of HIV infection called HIV CheX, following with the development of indigenous ELISA products for the detection of Hepatitis C (HEP CheX C), Neurocysticercosis (CYSTI CheX) and Japanese encephalitis (JEV CheX).

PositiveID Corporation Awarded U.S. Patent for First-of-Its-Kind Detection System for Molecular Biological Diagnostics

PositiveID Corporation ("PositiveID"), an emerging growth company and developer of advanced technologies for diabetes management as well as sophisticated airborne bio-threat detection systems for America's homeland defense industry, announced today that it was awarded U.S. Patent No. 8,133,451 for its Dragonfly™ Rapid MDx Cartridge-based diagnostic system, which provides the ability to deliver molecular diagnostic results from a sample in less than 30 minutes. Dragonfly enables accurate diagnostics leading to the potential treatment scenarios at the point of care that are not possible with existing systems.

Dragonfly has been proven effective for a broad range of biological detection 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). Dragonfly offers the precision of molecular diagnostics in an easy-to-use cartridge format that minimizes the possibility of human error. Typical current molecular diagnostic testing can take hours or even days, requires highly trained personnel and includes multiple handling steps.

William J. Caragol, Chairman and CEO of PositiveID, stated, "With Dragonfly, we have the ability to revolutionize the way healthcare is administered by enabling accurate diagnosis within minutes at the point of care, and before the patient leaves the physician's office. This allows healthcare professionals to prescribe the appropriate treatments immediately, helping to minimize the overuse of antibiotics, and enables rapid treatment and potential monitoring and quarantine measures for serious outbreaks such as certain forms of influenza."

The target markets for Dragonfly range from physicians' offices to urgent care and emergency departments that desire rapid test results and accurate diagnosis while the patient is present, and extend to military field deployments, border locations and others.

PositiveID Corporation is an emerging growth company and developer of advanced technologies for diabetes management and rapid medical testing, as well as airborne bio-threat detection systems for America's homeland defense industry. Its wholly-owned subsidiary, Microfluidic Systems, or MFS, is focused on the development of microfluidic systems for the automated preparation of and performance of biological assays in order to detect biological threats at high-value locations, as well as analyze samples in a medical environment.

Cepheid Receives Grant to Develop Sample Processing and Amplification Methods for Detection of Bloodstream Bacteria
Tuesday March 20, 2012
Cepheid today announced that, together with the University of Medicine and Dentistry of New Jersey (UMDNJ), it has received a grant from the National Institutes of Health to develop sample processing and amplification methods for highly-sensitive detection of bloodstream bacteria using nested polymerase chain reaction (PCR) on the GeneXpert® System. The $1.3 million grant is for the first year of an expected five-year, $5.5 million program.

While the program is being administered by the National Institute of Allergy and Infectious Diseases (NIAID) through its Partnerships for Biodefense special emphasis program, the company also expects to be able to employ the technology in future clinical products, including planned Xpert® tests for sepsis, ventilator pneumonia, and other critical infectious diseases.

"Cepheid's scientists will focus primarily on sample preparation methods for infectious agents from a wide variety of difficult sample types, especially whole blood — one of the most difficult specimens for sepsis detection," said John Bishop, Cepheid's Chief Executive Officer. "Clinicians want accurate, rapid results directly from a patient specimen without waiting for culture results. This program is expected to contribute to the advancement of products where difficult sample types are present."

Because even an extremely low concentration of bacteria present in a patient's blood can cause life-threatening sepsis, tests to detect blood stream infections (BSI) must be highly sensitive. Most blood stream infections are currently diagnosed by performing a series of blood cultures, a time-consuming process that typically takes days to produce a positive result, and even longer to predict treatment susceptibility.

The overarching goal of the project, scheduled to run through February 2017, is to develop tests to detect a variety of bacterial bioterrorism agents in the case of a terrorist attack. Principal investigator on the grant is Dr. David Alland of UMDNJ, and the work on select agents will be conducted in his laboratories.

"This is very similar to a previous NIAID-funded program conducted on tuberculosis, which supported development of six-color fluorescent detection and reagents-on-board," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "We considered that program to be a win-win because some of our tests, in addition to the MTB/RIF test, now employ six-color detection technology. We expect to see similar benefits — both direct and indirect — as a function of this new program, and expect to be able to fully leverage our capabilities in the areas of nested amplification and multiplex PCR pursuant to the next generation of GeneXpert products."

About the GeneXpert® System Molecular Diagnostic Platform

The GeneXpert 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 GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands found in clinical environments.

Monday, March 19, 2012

Now, Get Your Health Results in 8 Hours

Patients can heave a sigh of relief. A new diagnostic test kit can now detect symptoms of critical infections very quickly -- in seven to eight hours compared to the average 72 hours and more it takes in conventional tests, leading to quicker diagnosis and treatment of the infection.

The kit will reduce exorbitant testing charges and extended hospital stay costs for patients. The kit has been invented by Bangalore-based molecular diagnostics company, XCyton, with Rs 6-crore assistance from Council of Scientific and Industrial Research and private investors, including Biocon chairperson Kiran Mazumdar-Shaw.

The invention known as Syndrome Evaluation System (SES) has been described by American-based investors as the fastest, simplest, elegant and most cost-effective testing kit or tool in the world that can in just one test detect multiple bugs/organisms at work in critical infections.

"There are many diagnostic kits that do the same thing across the world but we haven't yet come across one that does it as rapidly and inexpensively as this kit does. We come from the Massachussets area where a lot of inventions do happen and we have come to this inference based on substantial research," said Ketan Patel of Fidelity, which has invested $ 4.5 million in product development and commercialization.

What Infections

The invention is targeted at speedier treatment of brain-related infections, sepsis, eye infections, cancer-related ailments, lung, joint, spine-related infections among others, which means people afflicted with these infections can expect faster test results, therapy and treatment now.

Scientist BV Ravi Kumar, XCyton founder and CMD, told TOI, "The new testing tool will identify the work of multiple organisms - bacteria, virus, fungi and parasites - in just one sample - that were causing a particular infection."

"Multiple tests to detect each of these organisms are no longer necessary. The test kit will show up all these different organisms at work in one test within seven to eight hours, as compared to the 3-7 days' time conventional tests take. One test in place of multiple tests will now reduce patients' bills," Kumar explained.

Kiran Mazumdar-Shaw, CMD, Biocon who has invested in her private capacity said: "I can relate to XCyton the very same way I built Biocon. Success for a biotech enterprise is about going from failure to failure without giving up. To get the correct outcomes, it all starts with correct diagnostics. We are poor at diagnosis and rush to treat patients. We use antibiotics as one-size-fits-all approach. Very often it doesn't work and has disastrous effects. Everyone thinks it's easy to build a company in biotech, because they often confuse it with IT. Biotech has huge challenges. The whole basis of discovering things, and validating those findings and translating them into commercial success is a much-harder journey. There are regulatory and scientific challenges. XCyton represents the new innovative India."

Shaw added that the biotech sector did not support the compulsory licensing recently accorded to Indian company for a cancer drug. "We felt this was not the cancer drug that needed compulsory licensing. It was only benefiting a minority segment, and by doing this, we are giving the wrong signals. We are frivolously giving away compulsory licensing. We are determined to innovate in biotech sector."

Celsis Rapid Detection Launches New RapiScreen™ Soy Beverage Kit

Celsis Rapid Detection announced today the launch of a new RapiScreen Soy Beverage kit, specifically designed for the detection of microbial contamination in soy and nut milks and similar beverage products.

The RapiScreen Soy Beverage kit provides beverage manufacturers with test results in as few as 48 hours, compared to 4-14 days with traditional methods, enabling them to release their products to market faster.

As the leading rapid detection system provider globally, Celsis Rapid Detection is committed to developing products to meet the ever-changing needs of the beverage, dairy and food industry. This new kit complements Celsis’ existing range of testing systems and meets a growing demand by customers for rapid testing of the increasingly popular soy- and nut-based drinks, including flavored and/or sweetened almond, coconut and rice milks. Celsis also has a RapiScreen beverage kit that is used to test a broad range of fruit and vegetable juices including orange, aloe and mango.

“As part of Celsis’ continuous improvement program we are pleased to launch the new RapiScreen Soy Beverage kit. Traditionally soy-based beverages have been more difficult to test using ATP bioluminescence because the amount of background ATP in the product can vary significantly. While Celsis’ latest Innovate.im software v5 offers the ability to compensate for product variability, the new Celsis Soy kit has been specially formulated to deplete background ATP in soy- and nut-based beverages, allowing manufacturers to more effectively test their products,” said Jeremy Robertson, Product Manager at Celsis Rapid Detection.

Manufacturers of packaged beverage products can use the Celsis RapiScreen Soy Beverage kit in conjunction with the Celsis Innovate™ luminometer and Innovate.im software to rapidly confirm the absence of microbial contamination. This helps companies save time and money by freeing up warehouse space and getting safe products to market faster.

Thursday, March 15, 2012

Akonni Wins $300K NIH Grant to Combine Flow Strip with PCR Array for Respiratory Dx Panel

Akonni Biosystems has received a $300,000 grant from the National Institutes of Health to integrate lateral flow strip technology with its PCR array-based respiratory pathogen assay, according to recently published grant information.

The eventual goal of the project, the company said, is to develop an automated point-of-care molecular testing device to identify hypervariable genomes across a panel of more than 30 common respiratory pathogens.

Akonni, based in Frederick, Md., has over the last few years been developing multiple platforms based on its TruDrop PCR technology, a low-density array of immobilized 3D 100-by-20-micron drops containing all probes and chemistry necessary for a PCR reaction. The company also has various imagers and thermal cyclers for use with its PCR arrays.

The new NIH grant, administered by the National Institute of Allergy and Infectious Diseases, will allow "flow cell technology [to be] built into our PCR array consumable," Kevin Banks, vice president for strategic development at Akonni, said in an e-mail to PCR Insider.

Flow strip technology has traditionally been used in immunoassays, but in recent years it has also been adopted by early-stage molecular diagnostic shops, particularly those interested in developing rapid, inexpensive, point-of-care platforms.

"This is the component that allows amplifiable material to flow from the consumables input port to the single chamber we use for PCR-based amplification, hybridization, and detection on a microarray," Banks said. "The result is a 'flow cell' consumable that provides lab technicians with the ability to perform high-multiplex assays in closed amplicon environments. This, of course, greatly reduces the risk for contamination caused by having high concentrations of amplicons present in an open container."

In its grant abstract, Akonni proposes to combine the flow-strip and TruDrop technologies into an "automated, sample-to-answer, point-of-care molecular device that identifies hypervariable genomes" in the following panel of respiratory pathogens: influenza A and B virus, human respiratory syncytial virus A/B, human adenovirus A/B/C/D/E/F, human coronavirus 229E/NL63/OC43, metapneumovirus, human rhinovirus A/B/C, human bocavirus 1/2/3/4, human parainfluenza virus 1/2/3/4, Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila, and Bordetella pertussis.

The ultimate goal is to develop a point-of-care test that identifies bacteria and viruses in this panel, including drug-resistant flu strains, from a single patient sample, Akonni said. "This test could assist in the preparedness for global pandemics because of the ongoing availability of a test that can identify a broad panel of contagious respiratory pathogens," the company said. "This strategy has the potential to eliminate the burden of having to quickly develop and commercialize single-organism tests in response to an emerging pandemic."

Soft Ray Looks to Save Lives by Developing Rapid, Low-Cost System for Detection of Bacteria in Blood Platelets

Paul E. Johnson envisions the day when most citizens can have their blood platelets checked quickly for bacteria at a low cost. And he has created the technology that he believes can make a difference in eventually saving lives.

Johnson, a University of Wyoming professor of physics since 1981, is venturing from the classroom to the boardroom with his biotechnology company SoftRay Inc., where he has created a lab instrument that can be used in hospitals and health clinics to detect bacteria in blood platelets or fungus in blood much earlier than current methodologies allow. And he is receiving assistance and expertise from the Wyoming Technology Business Center to make it happen.

"The WTBC has helped me develop a business plan. I've received feedback from venture capitalists and developed presentations to give to venture capitalists," says Johnson, who is currently in the pre-venture stage of his business idea. "They've helped me connect with a lot of people in the business community."

The WTBC is a statewide business development program (under the UW Office of Research and Economic Development) that is developing a technology business incubator and an outreach program focused on early-stage, high-growth companies. The 30,000-square-foot facility, which opened in 2006, offers laboratory, office and shared-conference room space for client companies as well as a state-of-the-art data center.

Johnson has created a technology he calls FountainFlow cytometry, which is used for measuring microorganisms in food, water and human blood. The platform technology can be used to detect environmental or drinking water contamination, fungus in the blood and bacteria in blood platelets -- and more quickly than current detection methods, Johnson says.

Platelets are the cells in human blood which cause blood to coagulate upon exposure to air. Platelets are used for transfusions for hospital patients who have undergone trauma or bled out; or for people who are immune-compromised, meaning their bodies cannot naturally produce platelets on their own.

Johnson says his technology -- which he began working on approximately six years ago because he wanted to make a significant societal impact -- can detect fungal infection in blood within a few hours compared to the current methodology, such as culturing, which takes 1-3 days to diagnose a form of fungus. That can be the difference between life and death for a patient who has gone into septic shock. A person can die from septic shock within 1-24 hours while current diagnosis typically takes 48-72 hours, Johnson says.

"A person's survival rate depends critically on quick diagnosis and treatment," Johnson says. "With our current FountainFlow platform technology, we will be able to make a diagnosis within 1-2 hours. And the physician will be able to use the appropriate drug regimen to save the person's life."

In his technology, Johnson says a fluid, such as blood or water, is mixed with chemicals. It is then pumped through the hoses of the instrument. The fluid is illuminated, using light from an LED. A dye is added to the fluid, which allows Johnson to pinpoint the microorganisms he's specifically interested in detecting. When the microorganisms are illuminated with the ultra-bright LED light, the microorganisms glow. A camera, which is part of the instrument, captures video frames of that fluid flow. A computer can analyze those frames to count the number of glowing particles in the images. It then determines the number of particles per volume in the fluid flow. This process allows the physician to determine the level of infection.

"Camera technology and LED technology have both become cheaper and more powerful," Johnson says. "I've managed to ride both of those waves to develop an instrument that can conduct cell detection."

Johnson currently is conducting his research with Poudre Valley Hospital in Fort Collins and Bonfils Blood Center in Denver. Poudre Valley Hospital is a 241-bed regional medical center which serves northern Colorado, southern Wyoming and western Nebraska. Bonfils operates six community donor centers; serves nearly 200 health care facilities in Colorado and beyond; and collects nearly 154,000 units of blood annually, according to its website.

While Johnson conducts his research at his laboratory in UW's Physical Sciences Building and at Bonfils -- with the aid of National Institutes of Health (NIH) grants -- he stressed that the WTBC and its facilities have been invaluable to his efforts.

"There is a lot of commercialization with something as complicated as this device. It requires meeting with (people in the) business and scientific fields," Johnson says. "I've been able to meet with people very good at dye development, and those that have to work with blood and blood platelets. I'm constantly getting feedback. They (WTBC) really care about the success of their clients."

He adds, "The great thing about the WTBC is we have a group of people intimately familiar with high-tech business development. It's really great to have someone identify problems. Before, I felt isolated. They (WTBC) have a lot of experience."

Johnson said he has lived and learned with a previous Laramie-based business venture, First Magnitude Corp., he started. First Magnitude marketed electronic, high-sensitive cameras used for research. While that company proved profitable, Johnson admitted to some business mistakes.

"We were attracting the high end of the market, but we didn't have the patents" for the technology, Johnson recalls. "If you don't have the patents, you get taken over rapidly by the big boys."

When he started SoftRay, Johnson shuttered First Magnitude Corp. And he vowed to learn from that experience.

While UW owns the patent on Johnson's technology, Johnson has an exclusive license on the patent, which means he owns the rights to market the technology.

Johnson says he is still mulling whether he would want to manufacture the technology himself or provide a license to a large corporation with production and manufacturing facilities already in place.

"I would like to be a Laramie-based company for the foreseeable future. The bio-detection industry is growing and is in excess of $30 billion annually," Johnson says. "I'd like to be a major player in the bio-detection industry."

In addition to the health care industry, Johnson sees other potential market applications -- including detection of contamination in food and water products -- for his technology.

"We're interested in licensing technology," he says. "If someone would want to use it for bottled water, that would be huge. The sky's the limit."

Wednesday, March 14, 2012

FDA Clears Meridian Bioscience's TRU Legionella Test

Meridian Bioscience, Inc. announced that it has received FDA clearance from the U.S. Food and Drug Administration (FDA) for TRU Legionella™, a new rapid assay for detection of legionellosis. TRU Legionella is a rapid lateral flow device that provides optimized detection of Legionella pneumophila serogroup 1 that is most commonly associated with Legionnaire's disease. Suspected infection is characterized by non-specific upper respiratory symptoms. The disease accounts for almost 100,000 cases per year in the U.S., and it is estimated that 10,000 to 20,000 people are hospitalized with Legionnaire's disease. However, many infections are not diagnosed due to poor diagnostic options and these numbers may be higher.

The TRU Legionella test provides a much needed solution for an often under-diagnosed disease. Approximately 4 million to 5 million cases of community acquired pneumonia occur each year in the U.S. and Legionella is implicated in 5-8% of the cases. According to published statistics, incidence of Legionella cases has nearly tripled in the past decade and could be attributed to increase testing for disease. TRU Legionella empowers laboratories with an accurate, cost effective, and rapid result for Legionella detection.

John A. Kraeutler, Chief Executive Officer, stated, "TRU Legionella is an important addition to our respiratory product portfolio given the prevalence of the disease. This new assay solidifies our position as a leader in rapid, accurate testing methods for infectious disease testing. TRU Legionella provides labs with a highly accurate tool that can speed the detection of an under-diagnosed pathogen enabling rapid treatment for the patient. TRU Legionella is in distribution, via Meridian Bioscience Europe, for our European customers."

Quidel Receives CE Mark for Its Molecular Diagnostic Test for Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV)

Quidel Corporation, a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received the CE Mark for the Quidel Molecular(TM) RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).

The CE Mark for Quidel's molecular RSV + hMPV assay clears the way for the launch of another infectious disease molecular test offering in Europe. The assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms.

Quidel Molecular RSV + hMPV is one of several forthcoming assays from Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These reagents provide attractive features that include simple transport and refrigerated storage (no freezer required), convenient workflow, a short time to result, and other benefits that favorably affect diagnostic test outcome. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside the Quidel Molecular Influenza A+B PCR assay in the same multi-well panel for customized multiplexing capability.

"We are very proud to receive CE Mark for RSV + hMPV, our newest Quidel Molecular product offering," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We are pleased with our ability to provide healthcare workers in Europe with a diversified set of molecular testing options while also making efficient use of their existing test infrastructure."

This assay is Quidel's third molecular product offering to receive authorization to market in Europe. Quidel Molecular assays for Influenza A+B and hMPV received CE Mark in August and September of last year, respectively. Quidel Molecular RSV + hMPV is not for sale in the U.S. at this time.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue(R), D3(R) Direct Detection and Thyretain(R) leading brand names, as well as under the new Sofia(TM) and Quidel Molecular(TM) brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, mononucleosis, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories.

Enzo Biochem's Clinical Laboratory Applies for NY State Health Department Approval for First Assay Based on Its AmpiProbe™ Amplification Platform

Enzo Biochem Inc. announced the filing of an application with the New York State Department of Health for the first assay based on its proprietary AmpiProbe™ nucleic acid detection platform. Upon approval, the Company plans to market its HCV RNA Quantification Assay for viral load determination through its Enzo Clinical Laboratory. The Company previously announced plans to seek CE-IVD designation for this assay in order to make it available as a diagnostic product in the European Union.

New York State's Department of Health ensures the quality of clinical laboratory tests, among others, through what is recognized as the country's most comprehensive licensure program.

The Company said that, compared with other leading platforms currently in use in what it estimates is a $2 billion market for nucleic acid-based tests, assays based on AmpiProbe™ platform may provide substantially greater sensitivity than conventional PCR-based tests. As a result, AmpiProbe™ assays would require less sample input, facilitating paneling or multiple preparations of tests per sample leading to economic efficiencies. The assay's utilization of this particular Enzo proprietary technology may thus reduce the need of obtaining multiple samples from patients, an important factor for both physicians and the patients.

"Our studies indicate that AmpiProbe™ based assays can provide a superior testing methodology through greater operational efficiency and economy than any similar platform currently on the market," said Barry Weiner, Enzo President. "By providing cost savings to clinical laboratories as well as potential benefits to medical practices, we believe that our AmpiProbe™ platform can lead to a new generation of nucleic-acid based assays.

"AmpiProbe™ HCV is the first assay developed from Enzo's proprietary nucleic acid amplification technology, and we view it as potentially a promising example of other molecular-based products that we currently have under development," Mr. Weiner added.

The Company previously announced that it would present for the first time clinical findings related to AmpiProbe™ at the March 31, 2012 meeting in London, England, of the European Society of Clinical Microbiology and Infectious Diseases. An abstract, entitled "Quantitative Detection of HCV RNA in Human Plasma-serum using the Enzo AmpiProbe™ HCV RNA Assay," has been accepted for publication in the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) official journal, Clinical Microbiology and Infection (CMI).

Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences and therapeutics through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards.

PositiveID Corporation : PositiveID Corporation's M-BAND Well Positioned for $3 Billion BioWatch Contract

PositiveID Corporation ("PositiveID"), a developer of molecular diagnostic systems for bio-threat detection, announced today that its M-BAND (Microfluidic-Bioagent Autonomous Networked Detector) system is well positioned to take part in the Department of Homeland Security's ("DHS") $3.1 billion BioWatch Gen-3 opportunity, expected to be released in the first half of 2012, and is the only system of its kind that was demonstrated in the field under the DHS Science and Technology ("S&T") BAND Program. PositiveID's patented M-BAND biodetector was developed under a competitive award from DHS S&T, and M-BAND was the only successful system to emerge from the BAND program.

M-BAND, protected by United States Patent No. 7,705,739 B2 for an Integrated Airborne Substance Collection and Detection System, was developed by PositiveID's Microfluidic Systems ("MFS") subsidiary under six years of funding from the federal government.

M-BAND is a bioaerosol monitor with fully integrated modular systems including sample collection, purification and detection modules. Each module is independently functional and adaptable. M-BAND runs autonomously for up to 30 days, continuously analyzing air samples for the detection of bacteria, viruses, and toxins with results in as little as three hours. Results from individual instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in aggregate. Also as part of the BAND Program, PositiveID developed, validated and implemented its own biological assays for use on the M-BAND system and research laboratories.

The M-BAND instrument offers a number of advantages including decreased consumable and operating costs, a small footprint, a closed operating environment and significant flexibility of operation. M-BAND has been designed and field tested to operate continuously for 30 days unattended between scheduled services. It also operates using industry gold-standard TaqMan® PCR (polymerase chain reaction) chemistry.

William J. Caragol, Chairman and CEO of PositiveID, stated, "We believe M-BAND is the only system of its kind that has been successfully field tested indoors and outdoors, both domestically and internationally. We further believe that M-BAND has significant benefits that set this technology apart and put us in a strong position to participate with large partners in the $3.1 billion BioWatch opportunity."

About PositiveID Corporation

PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays.

Friday, March 09, 2012

Molecular Detection Inc. Completes $1.5 Million Financing to Advance New Tests for Sepsis and GI Disorders

Molecular Detection Inc. (MDI), a company developing Detect-Ready® tests designed to increase the speed and accuracy of infectious disease diagnosis, today announced that it has completed a $1.5 million financing. The funds are primarily being used to advance MDI's new molecular diagnostic panels for the detection of sepsis and gastrointestinal (GI) diseases. Separately, MDI announced allowance of a new European patent for its stabilization technology, which enables Detect-Ready kits to be shipped and stored at room temperature while preserving the integrity of their reagents. The company also reported that a major teaching hospital in the UK recently completed a comparative study further demonstrating that MDI's Detect-Ready MRSA Panel is superior to a market leading MRSA assay from a global competitor.

"We appreciate the continuing support of our investors, which is enabling us to advance the development of our new molecular diagnostic assays for sepsis and serious gastrointestinal infections prevalent in hospitals," commented Todd Wallach, CEO and chairman of MDI. "The superior performance of the unique differential diagnosis technology that is the foundation for all of our tests was recently reconfirmed in an independent study comparing MDI's Detect-Ready MRSA panel to a market leading competitor. We believe that the Detect-Ready technology provides more accurate and useful information to healthcare providers in an economical, rapid and easy-to-use format, resulting in benefits for hospitals, payers and patients alike."

The new comparative data confirming the greater accuracy of the Detect-Ready MRSA panel was generated by researchers at St. Thomas' Hospital in London as part of an academic study. The study compared the performance of MDI's test and the Becton Dickinson GeneOhm MRSA PCR sold by BD Diagnostics. The researchers concluded that the Detect-Ready MRSA assay is superior to the GeneOhm panel in terms of specificity, while still providing a more rapid screening service compared to traditional microbiology culture methods.

Mr. Wallach continued, "Allowance of the new European patent for our shelf-stabilization technology further enhances the robust intellectual property estate protecting the distinctive advantages of our Detect-Ready technology, complementing our existing European and US patents for our differential diagnosis technology that can analyze multiple gene targets to achieve a highly accurate and informative result."

The two new test panels being developed by MDI also leverage its differential diagnosis technology. Sepsis is a potentially life-threatening complication arising from infection, most frequently in hospitalized patients. Diagnosing sepsis can be difficult and MDI's Detect-Ready sepsis panel is designed to test for a range of targets in order to pinpoint the underlying infection, allowing treatment to begin as soon as possible. Similarly, patients being treated in institutions are at risk for a variety of serious gastrointestinal infections that can be life threatening and costly. MDI's Detect-Ready gastrointestinal panel aims to be the first that can distinguish the source of the infection using a single molecular diagnostic test, facilitating timely and effective treatment. Beta testing for both the Detect-Ready sepsis and GI panels has begun in select healthcare facilities.

All existing investors, including MentorTech Ventures, Robin Hood Ventures, Elm Spring Holdings and the Mid-Atlantic Angel Group participated in the $1.5 million financing.

The Detect-Ready MRSA Panel is a qualitative real-time PCR in vitro diagnostic test that is marketed in the European Union (EU) and other territories and is in late-stage development in the US. It is CE-marked for the detection of MRSA (methicillin-resistant Staphylococcus aureus) and MSSA (methicillin-sensitive S. aureus) and is the only marketed PCR-based MRSA screening test with the proven ability to discriminate accurately between these pathogens and other related bacteria. Samples for testing are simple to obtain using nasal swabs and the kit's ready-to-use pre-mixed reagents require only the addition of patient sample to run the test, which provides results in less than three hours. Detect-Ready kits are compatible with a number of the real time-PCR platforms currently found in most hospitals. They offer healthcare providers a high-performance sample-to-answer disease screening panel with an unmatched combination of accuracy, speed, flexibility and cost-effectiveness.

* A Comparative Study of Two MRSA PCR Assays, Sarah L. White, Eugene P. Halligan, Penelope R. Cliff Infection Sciences, GSTS Pathology, St Thomas' Hospital, London, UK, 2011.

Labs, Infection Preventionists Need to Work Together to Facilitate Rapid Response to Healthcare-Associated Infections

The U.S. Department of Health and Human Services (HHS) estimates that about one in every 20 patients develops an infection each year related to their hospital care. The key to preventing an outbreak of potentially deadly healthcare-associated infections (HAIs) -- such as methicillin-resistant Staphylococcus aureus (MRSA) or C. difficile -- is identifying them before affected individuals can pose a transmission risk.

But, according to a survey released today by the Association for Professionals in Infection Control and Epidemiology (APIC) and the American Society for Microbiology (ASM), the typical turnaround time for laboratory test results may not be meeting expectations. Greater collaboration between labs and infection preventionists may hold the key to addressing the gap -- and to more effective management of some HAIs.

Most (51 percent) of the infection preventionists (IPs) surveyed indicated that they need results for MRSA screening tests within 12 hours to initiate the necessary precautions; however, MRSA cultures -- a traditional method for screening -- typically take 24 to 48 hours to complete.

The survey identified two factors that could be addressed to help resolve the discrepancy and reduce HAIs: the need for increased communication between IPs and lab professionals, and the lack of tools and resources for training and educating all healthcare personnel.

“These survey results indicate that there are areas for improvement in the relationship between IPs and lab professionals to ensure the best patient outcomes,” said Lance Peterson, MD, clinical advisor to ASM, director of Microbiology and Infectious Diseases Research at NorthShore University HealthSystem (Evanston, IL), and clinical professor at the University of Chicago. “In collaboration, APIC and ASM have the ability to improve communication between the laboratory and infection prevention and facilitate a more rapid response to HAIs.”

IPs and lab professionals surveyed indicated that they would value assistance in relationship building between the two groups (70 percent), hearing about other facilities’ experience in creating partnerships (83 percent), more education about best practices (78 percent), and resources for educating themselves and other staff (62 percent). Only 63 percent said their facility has effective infrastructure in place for training and educating staff about HAIs.

“As governing organizations increase penalties, scrutiny and reporting of HAIs, testing for HAIs will become even more important,” said Lillian Burns, MT, MPH, CIC, clinical advisor to APIC, and administrative director of Epidemiology/Infection Control, Staten Island University Hospital. “A collaborative working relationship between these two professional groups can significantly improve patient safety and care.”

The survey is a first step in the collaboration between APIC and ASM to reduce infections and improve patient outcomes. As part of APIC’s Building Bridges initiatives, the IP Col-lab-oration Project aims to improve patient outcomes by bridging the communication gap between IPs and lab professionals, augmenting tools and resources currently available, and educating healthcare personnel. For more information, please visit www.apic.org/labproject.

The survey was conducted by Mathew Greenwald & Associates (www.greenwaldresearch.com), a full-service market research company, from April 19 through May 11, 2011, with 1,839 respondents (8.9 percent response rate). Most respondents were APIC members (78 percent); ASM members represented 22 percent. Eighty-one percent of respondents work in a hospital setting.

Enzo Biochem to Present New AmpiProbe™ Nucleic Acid Amplification Platform at ESCMID London Meeting

Enzo Biochem Inc. announced that the company will present for the first time peer-reviewed data on detection of hepatitis C virus (HCV) using its novel AmpiProbe™ technology platform, which provides low cost and high sensitivity real-time nucleic acid amplification assays. The data will be unveiled at the upcoming meeting of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), scheduled for March 31-April 3 in London.

The abstract, "Quantitative Detection of HCV RNA in Human Plasma-Serum using the Enzo AmpiProbe™ HCV RNA Assay," has been accepted for publication in Clinical Microbiology and Infection, the official ESCMID journal. In addition, Enzo will seek CE-IVD (Conformite Europeenne in vitro diagnostic) designation for the company's HCV RNA assay, enabling the company to market the product as a diagnostic in the European Union.

Poised as a significant new entry in the market, the AmpiProbe™ HCV assay facilitates paneling -- or multiple tests per single sample, thereby requiring less sample for each test. In addition, the HCV assay utilizes highly efficient technology that employs less reaction volume.

"The AmpiProbe™ HCV assay provides a superior testing methodology through greater operational efficiency and economy than any similar platform currently on the market, and we are pleased to be able to present it at the highly prestigious ESCMID meeting," said Barry Weiner, Enzo President. "By providing overall cost savings in reagents and sample processing, the HCV assay is positioned to benefit physicians as well as patients. We believe that this assay represents the beginning of a new generation of nucleic acid-based molecular diagnostics."

Monday, March 05, 2012

BioConnections Licenses Hebrew University’s Rapid MDR Infection Test Kits

U.K microbiology products and services specialist BioConnections negotiated a licensing agreement with the Hebrew University of Jerusalem’s R&D and technology transfer arm, Yissum, to commercialize kits for the direct detection of any multidrug-resistant (MDR) and extremely drug resistant (XDR) infection in samples of patient urine or blood. BioConnections says the first kits are in the final stages of development, and are expected to reach the market within months. An application for CE mark approval in Europe is also in progress.

The technology underlying the kits has been developed by the University Faculty of Medicine’s professor Emeritus Nathan Citri, M.D. The approach provides a direct indication of bacterial resistance to all beta-lactam antibiotics by detecting the presence of beta-lactamase enzymes that are produced by MDR bacteria. The modular kits comprise disposable arrays of antibiotics, in a combination that can be customized. Unprocessed samples are then placed on the array spots, and covered with a lid containing an indicator, which rapidly changes color in the presence of antibiotic-resistant organisms.

“Currently available techniques for identifying drug resistant bacteria are slow or hardly accessible, and evidence-based decisions are delayed for days,” remarks Yaacov Michlin, Yissum CEO. “Professor Citri’s invention now enables hospitals to identify drug-resistant infections within minutes, so that the patient can immediately benefit from appropriate, evidence-based treatment while contagion and contamination are minimized.”

Global Gene Amplification Technologies Market to Reach US$2.2 Billion by 2017

Gene Amplification Technology addresses applications, such as molecular biology research, gene therapy, drug discovery, forensic identification and diagnosis, and is one of the rapidly growing markets in the area of life sciences. Molecular diagnostics and the Human Genome Project (HGP) have been the major growth drivers for gene amplification technology over the years. The industry continues to be affected with issues such as patent expiry, and competitive advantages associated with the existing and emerging technologies. Aging population, and the increasing incidence and prevalence of age-related diseases press the need for new diagnostics. Genetic testing is one such solution that makes use of gene amplification technology, which bodes the potential larger role that gene amplification technology could play in the area of diagnostics. With the growing improvements in the diagnostics market, DNA diagnostic technologies are set to achieve superior efficiencies and improved activity in numerous application areas, including healthcare, biomedical research, toxicology, bioremediation, forensics and personnel identification, environmental monitoring, quality control in the food industry, animal husbandry, and agriculture.

Polymerase Chain Reaction represents a major technique in the gene amplification space, with substantial penetration in the market. The market has been witnessing significant growth rate over the years, and has successfully weathered the recent economic downturn posting accelerated growth even during the period. Continued growth in the market, despite the external pressure, bodes well for the future growth of this technology in terms of market opportunities. Growth in the PCR market is, however, threatened in the wake of increasing application and the development of alternative technologies. Some of the alternative technologies existing in the market include Strand Displacement Amplification (SDA) and Ligase Chain Reaction (LCR). Growth in the PCR market, in the foreseeable future, is projected to be mainly driven by qPCR technique, closely followed by RT-PCR (Reverse Transcription PCR). Fuelled by the introduction of novel PCR instruments for the detection of several critical diseases, PCR continues to dominate the gene therapy market. Qualitative PCR is used for applications, such as monitoring gene expression levels and viral load. Reverse transcriptase PCR (RT-PCR) is a powerful tool for gene expression analysis because of its sensitivity, speed, ease of use, and versatility.

Burgeoning demand for molecular diagnostics in clinical settings is expected to drive the miniaturization of DNA-amplification technologies. Popularly known as DNA-amplification-on-a-chip, the technology encompasses a microfluidic device with sensors, heating aids, and a reaction container. Being portable, the device can be used in a doctor’s clinic or at a patient bedside. The technology is still in development and many companies are actively conducting research to develop a final solution/process for commercial use.

Global market for gene amplification technologies is led by the US, which is also the fastest growing market worldwide, as stated by the new market research report on Gene Amplification Technologies. Segment wise, PCR continues to dominate the gene therapy market, supported by roll out of several novel PCR instruments used for detecting most critical diseases. PCR allows amplification of genetic material in large quantities, and also enables the diagnosis of widespread diseases such as HIV. However, growth in the gene amplification technologies market would be driven by other gene amplification technologies, which are forecast to display stronger growth worldwide.

Major players profiled in the report include Abbott Laboratories; Becton, Dickinson and Company; bioMérieux; Bio-Rad Laboratories; Cepheid; Life Technologies Corporation; QIAGEN N.V; Roche Diagnostics; Rubicon Genomics; and Takara Bio, Inc.

The research report titled "Gene Amplification Technologies: A Global Strategic Business Report" announced by Global Industry Analysts Inc., provides a comprehensive review of the gene amplification technologies market, current market trends, key growth drivers, new product innovations/launches, recent industry activity, and profiles of major/niche global market participants. The report provides annual sales estimates and projections for the global gene amplification technologies market for the years 2009 through 2017. The study also provides historic data for an insight into market evolution over the period 2003 through 2008.

Meridian Bioscience Receives FDA Clearance For New Legionella Test

Meridian Bioscience, Inc. announced that it has received FDA clearance from the U.S. Food and Drug Administration (FDA) for TRU Legionella™, a new rapid assay for detection of legionellosis. TRU Legionella is a rapid lateral flow device that provides optimized detection of Legionella pneumophila serogroup 1 that is most commonly associated with Legionnaire’s disease. Suspected infection is characterized by non-specific upper respiratory symptoms. The disease accounts for almost 100,000 cases per year in the U.S., and it is estimated that 10,000 to 20,000 people are hospitalized with Legionnaire’s disease. However, many infections are not diagnosed due to poor diagnostic options and these numbers may be higher.

The TRU Legionella test provides a much needed solution for an often under-diagnosed disease. Approximately 4 million to 5 million cases of community acquired pneumonia occur each year in the U.S. and Legionella is implicated in 5-8% of the cases. According to published statistics, incidence of Legionella cases has nearly tripled in the past decade and could be attributed to increase testing for disease. TRU Legionella empowers laboratories with an accurate, cost effective, and rapid result for Legionella detection.

John A. Kraeutler, Chief Executive Officer, stated, “TRU Legionella is an important addition to our respiratory product portfolio given the prevalence of the disease. This new assay solidifies our position as a leader in rapid, accurate testing methods for infectious disease testing. TRU Legionella provides labs with a highly accurate tool that can speed the detection of an under-diagnosed pathogen enabling rapid treatment for the patient. TRU Legionella is in distribution, via Meridian Bioscience Europe, for our European customers.”

GeneWeave Biosciences Attracts Venture Capital to Develop It's First Molecular Diagnostic Product

GeneWeave Biosciences, developer of a platform for the rapid detection of infectious disease, today announced that it raised $12 million in a series A round of venture capital led by Decheng Capital. Existing investors Claremont Creek Ventures and X/Seed Capital also participated in the round.

The company also announced that Min Cui, Managing Director at Decheng Capital, will join the company's board of directors.

Steve Tablak, the CEO of GeneWeave Biosciences, said the latest infusion of capital will be used to complete the development, validation and clearance of the initial test for the company's platform. The company has developed a breakthrough molecular diagnostic technology for the detection of life threatening pathogens.

"Using patent-pending technology, the GeneScout™ platform, we will be able to deliver an unprecedented combination of performance and simplicity to hospital laboratories seeking to replace traditional microbiology with better performing molecular diagnostics," said Tablak.

"Decheng Capital led the latest venture round for GeneWeave Biosciences because we see the tremendous application for the technology both here in the United States and in China where there is fast growing demand for innovative molecular diagnostics products. GeneWeave has the opportunity to offer simplified workflow, rapid results and truly transformational technology," said Decheng Captial's Cui. "We believe that GeneWeave will continue to deliver exceptional results, as they have done throughout their early development."

"I'm very excited about GeneWeave's upside," added Ted Driscoll, a partner of Claremont Creek Ventures. "From the outset, we have imagined a wide range of applications for GeneWeave's innovative platform. This is one of our early stage companies that has consistently delivered results ahead of schedule and under budget. We could not be more excited to have a front row seat as this financing round will allow the dynamic management team to lead the company to first commercialization and beyond," Driscoll added.

GeneWeave Biosciences has created a new and innovative platform for the surveillance and detection of infectious disease. Their proprietary GeneScout™ technology offers a truly transformational solution for health care providers seeking to detect and prevent infection from potentially life-threatening organisms.

Cell Phone Attachment Can Rapidly, Inexpensively Detect E. coli

Engineers at the University of California – Los Angeles have created a cell phone attachment that may be able to rapidly and inexpensively detect pathogenic E. coli bacteria in liquefied food samples or water.

The device, which is portable, lightweight and compact and can attach to an existing cell phone camera, acts like a fluorescent microscope. The device was successful in tests using a specially-prepared buffer solution and milk and may be able to detect other pathogens through the use of different antibodies.

To use the device, scientists pump a sample into a series of small tubes in the device that have been treated with E. coli antibodies and lit with battery-powered light-emitting diodes. The light excites the labeled E. coli particles and emissions from quantum dots are imaged using the cell phone camera and an additional lens. The phone then quantifies the florescent light emission from each tube to determine the concentration of E. coli bacteria in the sample.

The details of the study were published in The Royal Society of Chemistry. The researchers were from the UCLA Henry Samueli School of Engineering and Applied Science. Authors of the study include Aydogan Ozcan, an associate professor of electrical engineering and bioengineering, Hongying Zhu, an electrical engineering postdoctoral scholar, and Uzair Sikora, an electrical engineering undergraduate student.

Abbott to Collaborate on Rapid Molecular Test to Identify Serious Infections in Bones and Joints

Abbott announced today it will collaborate with Genetics Laboratory, Inc. (GenLab) on the development of a molecular diagnostic test that will be designed to rapidly detect microorganisms that cause orthopedic infections. Under terms of the agreement, Abbott, in conjunction with GenLab, will develop and commercialize the new assay for use on the PLEX-ID(TM) automated microbial identification system. In the United States, PLEX-ID is currently intended only for non-diagnostic use, but assays are now being developed for future clinical diagnostic uses.

PLEX-ID has the ability to rapidly identify a broad variety of microorganisms. The system is capable of generating results within five to six hours in contrast to other methods, which may take several days or longer for positive identification.

"Bacteria, particularly antibiotic-resistant species such as MRSA, are very dangerous in orthopedic patients because the bacterial colonies attach to the artificial surfaces of the implants," said Gerhard Maale, M.D., an orthopedic oncologic surgeon and an expert in orthopedic infections in the Dallas-Ft.Worth area. Dr. Maale will also serve as the medical director for the Abbott-GenLab collaboration.

"A molecular diagnostic test designed to detect microorganisms that cause orthopedic infections, running on the PLEX-ID, could have the ability to determine which pathogens are responsible for an infection while assessing the genetic composition and potentially antibiotic resistance," Dr. Maale said. "This could be a major step forward in diagnosing and treating serious infections in artificial joint recipients, with the potential to provide important information to physicians that they could use to save treatment costs and improve the quality of life for these patients."

Bacterial infections can occur during hip and knee replacement procedures and are difficult to diagnose and treat. Bacteria, such as MRSA, form slimy colonies known as biofilms in artificial joints and can be resistant to antibiotics. Biofilms are difficult to identify using traditional bacterial culture test methods since the organisms clump together and do not grow well for positive identification, often leaving physicians with very little information to guide their treatment decisions. According to The New England Journal of Medicine, about 800,000 knee and hip replacement procedures are performed annually in the United States, and complications related to infections occur in approximately 2 percent of those procedures. In addition, more than 70,000 joint revisions are performed annually in the United States, with greater than 15 percent of hip and 25 percent of knee revisions caused by infections. Revisions are often more expensive than the original procedure.

Epistem and Xcelris Sign Sales and Marketing Deal for TB Test

Stem cell specialist Epistem has signed a sales and marketing deal for its novel tuberculosis test with Indian genomics firm Xcelris Labs.

Xcelris will now be the channel partner for distribution of the Epistem’s technology across India and the Indian sub-continent. This deal follows a collaboration agreement signed by the two firms last June.

The technology behind new rapid molecular test for TB is Epistem’s Genedrive platform, which provides a 'Point of Care' test applicable to a wide range of viral, bacterial, fungal and somatic mutation disease areas in less than thirty minutes.

Epistem said Genedrive will be targeted at providing the 'gold standard' for TB identification and antibiotic resistance testing and will be priced competitively against other methods of diagnosis such as microscopy and culturing.

India has the largest number of TB sufferers in the world, with 2 million new patients each year with the highest incidence of fatalities occurring in remote rural areas.

Following regulatory approval, Genedrive will be positioned to be included as part of the Indian Revised National TB Control Program (RNTCP).

Xcelris will liaise with RNTCP to offer innovative and easy-to-use diagnostic solutions to detect TB.

Epistem added that Genedrive can also be used for diagnostic testing across a broad spectrum of infectious diseases such as TB, Dengue Fever, HIV and a wide range of sexually transmitted diseases.