Monday, March 31, 2014

PrimusLabs Strengthens Commitment To Food Safety Testing With Adoption Of Roka Bioscience's Atlas System

Roka Bioscience announced today the adoption of the Atlas System by PrimusLabs, which is headquartered in Santa Maria, California. PrimusLabs has made the technologically advanced pathogen detection system an integral part of the infrastructure in each of its United States microbiological laboratories in California, Arizona, and Florida as well as its lab in Mexicali, Baja California, Mexico. PrimusLabs is a food safety company specializing in fresh produce and offers microbiological testing as well as pesticide residue analyses, auditing services, education and online tools, and data management.  It has implemented the Atlas System for all fresh produce commodities.

The Atlas System is a fully automated molecular system that enhances the accuracy and efficiency of food safety testing through the detection of molecular pathogens. PrimusLabs has invested in this technologically advanced system on behalf of its clients.

PrimusLabs, the single point of contact among the fresh produce industry’s leading producers, packers and procurers for food safety audits, micro and pesticide residue testing, and data management, provides the knowledge, training, and customer service to help clients confidently supply and process food products that meet buyer’s demands.

Roka Bioscience is a molecular diagnostics company focused on developing and commercializing advanced testing solutions for the food safety testing market. Our Atlas Detection Assays incorporate our advanced molecular technologies and are performed on our “sample-in, result-out” Atlas System that automates all aspects of molecular diagnostic testing on a single, integrated platform. The Atlas System and Detection Assays are designed to provide our customers with accurate and rapid test results with reduced labor costs and improved laboratory efficiencies.

A High-Tech Real-Time Solution for Detecting Bacteria in Water

Water quality and safety can never be taken for granted. Every day, millions of tons of inadequately treated sewage, industrial and agricultural wastes are poured into the world's lakes, rivers, and oceans - the equivalent of the weight of the entire human population in the form of pollution. Many industries, from food to metal working, require huge quantities of water for their processes and water quality may seriously affect the quality of finished products.

Researchers on an EU-funded project have devised an innovative new way of potentially combating waterborne death and illness.

They have developed a high-tech device designed to detect bacteria in water. The new system will be able to monitor, in real time, the quality of industrial process water and effluents using an 'opto-ultrasonic' device and lipid- based diagnostic kit.

This is the result of the AQUALITY initiative, a project launched in December 2011 and funded under the EU´s Seventh Framework Programme. The research ended in February and the device is currently undergoing field tests in Norway.

These field tests are of crucial importance for the industry, where water quality impacts directly on production performances, operational costs and sustainability.

The danger posed by pollutants is illustrated by the fact that fresh water contaminated with pathogens used in the preparation of food has been the source of foodborne disease. It is estimated to cause 76m illnesses and 325 000 serious illnesses resulting in hospitalisation and 5 000 deaths in the USA each year alone. The situation in Europe is similar - in the UK, for example, foodborne and waterborne illness affected one in every 1 000 in 2005, doubling the number of reported cases in 1995.

Identifying pollutants in water is, currently, mostly carried out manually through sampling and laboratory analysis (off-line analysis). But existing methods are time consuming and costly, meaning that the number of analyses have to be kept to an absolute minimum.

This is why industry called for both novel and cost-effective solutions and more rapid methods, online and at laboratory scale, for detecting major waterborne pathogens.

The online water monitoring device developed under the AQUALITY project is the first of its kind and is designed to replace routine sampling and lab testing of pathogens. The system will be able to detect a range of bacteria strains in water, including salmonella, listeria monocytogenes and campylobacter.

The US Department of Agriculture estimates the medical costs and productivity losses associated with these three types of bacteria alone amounts to at least $6.9 billion annually.

AQUALITY involved a multi-member state consortium, coordinated by the Spanish company, ENSATEC.

Jose Manuel Ochoa Martinez, from the project, said the three-year research had produced tangible results, notably a new method for microbiological contamination analysis which will 'rapidly' detect the presence of bacteria strains in water and wastewater. Preliminary results, he noted, are 'really promising and in line with expectations.'

He added, 'The novelty of our approach is the use of engineered liposomes for detecting bacteria in water. This achievement represents a potentially huge competitive advantage for the enterprise proposing it and could open up a significant international market.'

PositiveID Signs Agreement With UTC Aerospace Systems for U.S. Government Contract

PositiveID Corporation, a developer of biological detection and diagnostics solutions, is proud to announce that it has signed a contract with UTC Aerospace Systems' ISR & Space Systems unit to support a contract for the U.S. Department of Defense ("DoD"). This contract is expected to be performed over the next seven months, between March and September, 2014.

This contract will support the DoD Joint United States Forces Korea Portal and Integrated Threat Recognition ("JUPITR") Program, which is intended to detect biological threats in order to protect our nation's warfighters and allies. The JUPITR program will test and evaluate PositiveID's biological detection and identification technology called M-BAND (Microfluidic Bioagent Autonomous Networked Detector). The assessment will baseline performance, reliability, maintainability, ease of use, and cost of operation to provide the "best of breed" and most affordable options for the U.S. Army and U.S. Air Force.

PositiveID's Chairman and Chief Executive Officer, William J. Caragol, stated, "We are very pleased to work together with UTC Aerospace Systems to deliver M-BAND systems for testing and evaluation for the protection of our warfighters and supporters through the JUPITR Program."

About PositiveID's M-BAND Technology

M-BAND (Microfluidic Bio-agent Autonomous Networked Detector) continuously and autonomously analyzes air samples for the detection of biological airborne threats in the form of bacteria, viruses, and toxins. The technology was developed under contract with the "DHS" Science & Technology directorate, and is designed to detect the release of pathogens into the air as part of a defense against potential terrorist attacks.

Friday, March 28, 2014

Quidel Receives FDA Clearance for Its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Herpes Simplex Virus Types 1 and 2

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue HSV 1+2 Assay for the differentiation and detection of herpes simplex viruses 1 and 2.

The AmpliVue HSV 1+2 Assay is easy-to-use, handheld and disposable. The assay requires no upfront extraction of DNA and generates an accurate result in approximately one hour. Like other previously FDA-cleared AmpliVue assays, the AmpliVue HSV 1+2 Assay does not require investment in expensive thermocycling equipment. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.

The Centers for Disease Control and Prevention (CDC) estimate that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection.(1)

"We are pleased to launch our third AmpliVue assay and are certainly delighted by the acceleration in the pace of AmpliVue product development by our organization since BioHelix's acquisition in May of last year," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Hospitals are becoming increasingly aware of the AmpliVue brand, and we plan to build on that momentum with even more AmpliVue product introductions later this year."

The AmpliVue product line now enables laboratories of all sizes to perform highly sensitive and specific molecular tests for four pathogens -- two viruses and two bacterial species -- without incurring the significant expense that is usually required to adopt and maintain molecular testing methods on-site. The AmpliVue HSV 1+2 is Quidel's third assay to launch in its hand-held, disposable format. The AmpliVue C. difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA received FDA clearance in December of 2012. The AmpliVue GBS Assay for the molecular detection of Group B Streptococcus infections received FDA clearance in December of 2013. All three assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.


Wednesday, March 26, 2014

Chembio's HIV Assay Receives CE Mark Approval

Chembio Diagnostics, Inc., a leader in point-of-care ("POC") diagnostic tests for infectious diseases, announced today that its HIV 1/2 STAT-PAK(R) Assay received CE Mark approval from European regulators. The Chembio HIV 1/2 STAT-PAK(R) Assay is now cleared for commercialization within the European Union for rapid, POC detection of HIV.

According to the World Health Organization (WHO), more than 1.5 million people have been diagnosed with HIV in the European Region since the start of the epidemic, including 131,000 new HIV cases in 2012. The WHO reports that in 2012, 50% of newly diagnosed HIV infections in the European Region were diagnosed late (with CD4 cell counts below 350/mm) and 30% even later (with CD4 cell counts of 200/mm or lower), causing delayed initiation of antiretroviral therapy. Based on this data the WHO reports that an increase in HIV testing and counseling needs to be scaled up in the battle against this disease.

"We believe the Chembio STAT-PAK(R) HIV 1/2 and SURE CHECK(R) HIV 1/2 Assays are important tools in the fight against HIV/AIDS. The simple test procedure, fast turnaround time, and reliable results make Chembio STAT-PAK(R) HIV 1/2 and SURE-CHECK(R) HIV 1/2 uniquely suited for clinical and outreach settings, allowing immediate patient counseling and referral," stated John Sperzel, President and CEO of Chembio.

"In the coming months, we expect to launch the Chembio HIV 1/2 STAT-PAK(R) Assay and recently CE marked Chembio SURE CHECK(R) HIV 1/2 Assays in Europe. In addition, we continue to work with regulators in Europe to obtain CE Marks for the Chembio DPP(R) HIV 1/2 Oral Fluid test and the Chembio DPP(R) HIV-Syphilis test," added Sperzel.

Invisible Sentinel receives AOAC Certification for Salmonella 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 Salmonella species received certification from the Association of Analytical Communities (AOAC).

The Company's Veriflow® Salmonella species assay (Veriflow® SS) has been approved to detect bacterial contamination by Salmonella in multiple food types, including ready-to-eat foods, deli meat, and dairy products, and on various surfaces with which food is in contact during preparation and packaging.

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 US Department of Agriculture, the Food and Drug Administration, and global regulatory agencies.

With the certification of Veriflow® SS, Invisible Sentinel has now achieved AOAC approvals for multiple assays designed to protect against illness due to contaminated food. The Veriflow® Listeria species assay (Veriflow® LS) was approved earlier this year, and the Veriflow® Campylobacter assay (Veriflow® CA) and Veriflow® Listeria monocytogenes assay (Veriflow® LM) received approvals last year.

Nick Siciliano, Chief Executive Officer and co-founder of Invisible Sentinel, commented: "Achieving additional AOAC certifications for the growing number of assays in our Veriflow® product line remains a primary initiative as we focus on commercial growth and strive to reach a broader client base. We're excited to have built a comprehensive suite of novel and exceptional AOAC-approved pathogen diagnostics for the food and beverage industries. We are also actively expanding our Veriflow® product portfolio across additional industries through our custom-solution program."

Ben Pascal, Chief Business Officer and co-founder of Invisible Sentinel, added: "As we expand our roll-out of varied assays, we are hearing from the commercial market what we heard during field-testing: Veriflow® technology offers a unique combination of accuracy, ease of use, and speed to results."

Food poisoning due to Salmonella remains a significant public-health problem in the U.S., where testing for this foodborne pathogen accounts for upwards of 40% of the food-testing market. According to the Centers of Disease Control and Prevention (CDC), about 42,000 cases of food poisoning due to Salmonella are reported every year, and the actual number may be far greater. Although many cases are mild, it is estimated that 400 people die of Salmonella infection each year.

Currently, the CDC is investigating an outbreak that has spread to 25 states. Though first reported last year, the outbreak has been persistent, resulting in 481 reports of people who have become ill, 38 percent of them requiring hospitalization. The outbreak strains are resistant to several commonly prescribed antibiotics.

Invisible Sentinel anticipates AOAC approval of a fifth assay in the Veriflow® product line, the Veriflow® STEC assay (Veriflow® STEC), later this year.

Thursday, March 20, 2014

Fio's Deki Reader Meets Field Evaluation Objective for Rapid Malaria Detection

A field evaluation recently published in Malaria Journal demonstrated consistent interpretation of rapid diagnostic tests (RDTs) for multiple disease strains between Fio Corporation's Deki Reader™ and laboratory experts. The field evaluation analyzed results from 1,807 cases tested with an RDT for the two species of malaria responsible for most infections worldwide.

Widespread use of RDTs in low-resource settings is regarded as a pivotal strategy in malaria control and elimination efforts, particularly after the World Health Organization recommended parasitological confirmation of all malaria cases to reduce inappropriate use of anti-malarial drugs.

"Large-scale implementation of rapid diagnostic testing in malaria programs frequently results in poor diagnosis because operators often have limited expertise," said Dr. Sócrates Herrera, director of the Caucaseco Scientific Research Center in Colombia. "This trial demonstrated that even when using RDTs with multiple antigens, the Deki Reader's automated interpretation can be trusted to deliver high-level accuracy."

Fio Corporation conducted the field evaluation in collaboration with the Caucaseco Scientific Research Center, the lead institution behind the Centro Latino Americano de Investigación en Malaria (CLAIM), one of 10 International Centers of Excellence for Malaria Research funded by the U.S. National Institutes of Health.

The field evaluation analyzed results from cases tested with an RDT capable of detecting Plasmodium falciparum and Plasmodium vivax species of malaria at seven health facilities in malaria-endemic areas of Colombia. Seven study technicians, all trained laboratory microbiologists with rapid diagnostic testing experience, used Deki Readers to process the RDTs according to manufacturer recommendations; the Deki Readers provided job aids and helped the study technicians keep track of the incubation time for each RDT processed.

Once the incubation period was completed, the study technicians interpreted the RDTs by visual inspection and entered results using the Deki Reader's touch screen. The study technicians then immediately inserted the RDTs into the Deki Reader to obtain an objective interpretation of the test.

Researchers concluded that the diagnostic performance of the Deki Reader was comparable to the visual interpretation of the RDTs. They further suggested that large-scale implementation of rapid diagnostic testing in malaria programs would greatly benefit from the standardized, automated interpretation and near real-time reporting of test results provided by the Deki Reader.

The Deki Reader is a key component of the Fionet™ platform, which enables expert-level rapid diagnostic testing, while integrating data capture into clinical workflow to give stakeholders a window into the point of care.

The results of this field evaluation in Colombia follow validation of the Deki Reader's automated RDT interpretation from a previous field evaluation in Tanzania testing for a single species of malaria. Published in Malaria Journal in 2013, those results similarly demonstrated that the Deki Reader's objective RDT analysis was comparable to visual interpretation by laboratory technicians.

BD Receives 510(k) Clearance and CLIA Waiver for Rapid RSV Test

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today that it received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for nasopharyngeal swab specimens on the BD Veritor(TM) System for Rapid Detection of Respiratory Syncytial Virus (RSV). This is the first commercially available rapid CLIA-waived RSV test system that incorporates a digital result. The new assay is cleared for use in physician offices, hospitals, and other patient-care settings.

According to the U.S. Centers for Disease Control and Prevention, RSV is the most common cause of pneumonia and bronchiolitis in the United States in children under one year of age, leading to approximately 75,000 to 125,000 hospitalizations annually. Most children hospitalized for RSV infection are under six months of age.(i) Almost all children have been infected with the virus by the time they are two years old.

"Early and reliable detection of RSV is critical among high-risk populations to treat and prevent the spread of this contagious virus and hospitalizations," said Alberto Mas, President, BD Diagnostics -- Diagnostic Systems. "The CLIA-waived BD Veritor System for Rapid Detection of RSV has demonstrated good performance when compared to PCR, the highest reference lab based standard, while providing an objective test result in only 10 minutes."

When used in conjunction with the BD Veritor System Reader, the RSV test utilizes Advanced Nano-particle and Adaptive Read technologies to obtain an accurate result while providing objective results on a hand held reader with an easy-to-read digital display. The Advanced Particle Technology along with improved chemistries helps improve the sensitivity of the test while the Adaptive Read Technology helps reduce false-positive results by examining and compensating for many of the effects of non-specific binding which improves specificity. This digital immunoassay (DIA) for Rapid Detection of RSV offers healthcare professionals a new option for RSV testing versus current visual read CLIA-waived assays.

The CLIA-waved BD Veritor System for Rapid Detection of RSV joins the previously FDA-cleared and CLIA-waived BD Veritor System for Rapid Detection of Flu A+B and Group A Strep. The BD Veritor System for Rapid Detection of RSV is the third CLIA-waived offering and BD plans to launch additional FDA-cleared assays on this platform.

Wednesday, March 19, 2014

Associates of Cape Cod Announces Rapid FDA Licensed Endotoxin Detection Kit

Associates of Cape Cod, Inc. (ACC) announced the introduction of a new, FDA licensed version of our rapid endotoxin detection kit, Pyrosate®.  Pyrosate® is well suited for performing endotoxin assays in full compliance with the Bacterial Endotoxins Test, USP chapter <85>.  Pyrosate® has been developed as an easy-to-use Limulus Amebocyte Lysate (LAL) gel-clot test that enables rapid testing and does not require special laboratory supplies. The easy to follow, step-by-step illustrated instructions allow the user to set up assays within minutes.

In addition to FDA licensure, the Pyrosate® Kit is now available in sensitivities of 0.03 EU/mL, 0.125 EU/mL and 0.25 EU/mL, in both 10 pack and 30 pack formats.  With the introduction of this licensed version, in addition to research and water testing, Pyrosate® is ideal for dialysis centers, compounding pharmacies, pharmaceutical and medical device companies.

Dr. AJ Meuse, President and CEO, said, “ACC is the pioneer in endotoxin detection and the first company licensed by the FDA to manufacture LAL for use as a quality control test. We are constantly looking at new approaches to improve existing product offerings and introduce innovative new products. We are quite proud to introduce the newly FDA licensed Pyrosate® Kit.”

ACC is an industry innovator and has been a leading global supplier of endotoxin and glucan detection products and services for 40 years. During this time, ACC has supplied our customers with products and services that have helped ensure the safety of their parenteral drugs, biological products and medical devices.

AdvanDx Announces FDA 510(k) Submission for mecA XpressFISH - Rapid Detection of MRSA From Positive Blood Cultures

AdvanDx today announced that it has submitted to the U.S. Food and Drug Administration for 510(k) clearance its new mecA XpressFISH™ test for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from S. aureus positive blood cultures. This assay will provide physicians with a new way to rapidly identify MRSA enabling them to implement appropriate treatment for patients with bloodstream infections.

Methicillin-resistant Staphylococcus aureus (MRSA) is resistant to antibiotics commonly used to treat ordinary staphylococcal infections. An estimated 80,461 invasive MRSA infections occurred in the U.S. in 2011. Of these, 48,353 were healthcare associated community onset infections; 14,156 were hospital-onset infections; and 16,560 were community-associated infections.(1)

Methicillin-resistance is almost exclusively caused by the presence and expression of the mecA gene that encodes a unique penicillin-binding protein (PBP2a) that has low affinity for methicillin and other b-lactam drugs. mecA XpressFISH is a qualitative fluorescence in situ hybridization (FISH) assay that utilizes peptide nucleic acid (PNA) probes hybridizing to mecA messenger RNA (mRNA) sequences on smears from blood cultures containing Staphylococcus aureus (SA).  This "phenotypic" mRNA-targeting approach makes XpressFISH unique in its mechanism of MRSA identification.

"This is a significant breakthrough in how we identify MRSA," says James M. Coull, Ph.D, Chief Technology Officer for AdvanDx. "By targeting mecA mRNA, mecA XpressFISH rapidly detects the presence of the mecA gene, and determines whether the gene is transcriptionally functional and therefore able to confer resistance to broad classes of antibiotics, such as penicillins and cephalosporins. This information should help clinicians quickly determine the best course of antibiotic treatment."

Although identification of MRSA is used to guide effective therapy, conventional laboratory methods can take 48 hours to  determine whether S. aureus bacteria are resistant. mecA XpressFISH will enable laboratories to rapidly detect MRSA directly from S. aureus positive blood cultures in about an hour.  The rapid determination of MRSA by mecA XpressFISH should enable clinicians to prescribe more effective appropriate therapy sooner for MRSA-infected patients.

A Proven Track Record with Staphylococcal Bloodstream Infections

mecA XpressFISH is the latest addition to AdvanDx's easy-to-use, molecular-based diagnostics platform that provides rapid identification of bloodstream pathogens in minutes instead of days. AdvanDx also markets the QuickFISH platform for rapid identification of Gram-positive and Gram-negative bacteria as well as PNA FISH for Candida species.

Since 2003, the use of AdvanDx's flagship product, PNA FISH for rapid identification of staphylococcal bloodstream pathogens has dramatically improved therapy decisions and outcomes for patients with bloodstream infections by helping physicians and pharmacists optimize antibiotic therapy earlier. A clinical study performed at the Washington Hospital Center (Washington, D.C.) demonstrated that rapid identification and notification of PNA FISH results reduced ICU and overall mortality rates by 82% and 53% respectively, while reducing antibiotic use for patients with CNS positive blood cultures. In a separate study performed at the University of Maryland Medical Center (Baltimore, MD) rapid PNA FISH results, helped reduce unnecessary vancomycin use by 4.5 doses, length of stay by 2 days and hospital costs by $4,005 for patients with CNS contaminated blood cultures. (2,3)

1. JAMA National Burden of Invasive Methicillin-Resistant Staphylococcus aureus Infections, United States, 2011
2. Ly et al. Ther Clin Risk Manag. 2008 Jun;4(3):637-40.
3. J Antimicrob Chemother. 2006 Jul;58(1):154-8.

MedMira to Submit Cutting-Edge Rapid HIV Test for WHO Prequalification

MedMira Inc. will submit a new application for its most advanced Reveal Rapid HIV Antibody Test (Reveal HIV) to the WHO Prequalification of Diagnostics Programme. The latest version of Reveal HIV, recently approved in the European Union, delivers faster and more convenient point-of-care testing in the field through its simplified test procedure and the direct use of whole blood specimens. These new features are also in the Reveal and Multiplo products currently being commercialized in preparation for FDA submission.

The MedMira management team made the decision to submit its most advanced Reveal HIV test to the WHO for prequalification based on the company's commitment to offer state-of-the-art technology and testing solutions to every corner of the world. Prequalification of the latest Reveal HIV format will also enable MedMira's global strategic partners to bring the best technology and products to all markets where care providers and patients can benefit from faster, more cost-effective testing solutions. As MedMira rolls out this advanced version of Reveal HIV around the globe, legacy products will be phased out and the company will no longer support previous versions of the test, including the format originally submitted to the WHO for prequalification.

"Healthcare providers around the world are demanding the most advanced technology that qualified rapid test developers have to offer in order to meet the increasing need for screening tools that help prevent and control the spread of deadly diseases like HIV. By submitting Reveal HIV, built on the latest advances in our Rapid Vertical Flow Technology, for prequalification, MedMira is answering the WHO's call for state-of-the art, innovative products needed in their programs," said Hermes Chan, CEO, MedMira Inc.

Chan added, "Cost efficiency combined with high quality tests are critical to all government and non-government organizations running testing programs. MedMira is creating new modelling tools to help care providers optimize their program outputs and maximize available budgets, especially important in regions where large scale screening programs have the most impact. Our goal is to provide a comprehensive testing solution that includes the most advanced diagnostic technology, the highest quality tests, and optimization tools to save lives."

MedMira's New Miriad RVF Toolkit Offers Researchers Speedier Test Results

MedMira, Inc., a developer of rapid diagnostic technology and solutions, announced the launch of their Miriad RVF Toolkit for speeding the path to accurate test results for the research, academic and test developer markets. The new toolkit not only accelerates the test development process, but also empowers researchers to obtain results quickly and easily in a mobile, real-time setting.

The Miriad RVF Toolkit is a fast and cost-effective alternative to traditional laboratory-based testing methods, which often require expensive equipment from multiple vendors and restrict testing to central laboratories vs. the flexibility of the field. In addition to simplifying and speeding the road to test results, the toolkit enables researchers to transfer their science to a proven test platform, which can propel rapid commercialization.

The debut of the Miriad RVF Toolkit, part of the Miriad research products portfolio, marks a strategic expansion for MedMira into the U.S. research and academic markets and augments the company's strength in the clinical healthcare sector. The technology in Miriad, MedMira Rapid Vertical Flow Technology(TM), also is used in the company's rapid tests for the clinical healthcare market. These commercialized tests are approved by many global regulatory bodies. The exclusive distributor of the Miriad RVF Toolkit in the United States is VWR International, LLC, a global solutions provider of laboratory supplies and services with worldwide sales in excess of $4.1 billion in 2012.

Veterinary medicine researcher Dr. Joaquín Patarroyo is among early adopters of the technology. A professor at Brazil's Universidade Federal de Viçosa and product development and intellectual property advisor for Patsos Biotecnologia, Dr. Patarroyo sought a way to transition his successful laboratory work into a real-time, mobile testing environment. "Using MedMira's toolkit, my lab was able to develop rapid tests as effective as our laboratory-based assays. We created the tests within a much shorter turnaround time and did not need to procure components from multiple sources," said Dr. Patarroyo.

The toolkit also provides a simple migration route for conventional tests such as ELISA* and Western blots* to evolve into rapid tests. "MedMira is expanding its foot print in the research and academic markets with the Miriad RVF Toolkit based on the growing demand for simpler and faster screening tools and lab processes," said Kevin Jones, Ph.D., senior director, global sales and marketing, MedMira. "Researchers want greater freedom from the lab bench. They want alternatives to time-consuming lab-based assays. They demand an accurate testing solution usable anywhere, from the lab to the field. These researchers and educators now have access to a powerful product from our company to facilitate the advancement of new rapid tests."

The Miriad RVF Toolkit is for research use only.

*ELISA refers to the enzyme-linked immunosorbent assay, a prevalent type of laboratory test for the detection of antigens and/or antibodies. Western blot refers to a dot blot technique used to confirm the initial reactive results obtained from ELISA. These tests typically are performed in a laboratory setting and do not lend themselves to mobile testing at the point of sample collection.

Wednesday, March 05, 2014

British High Commissioner Donates Diagnostic Kits

Mr Peter Jones, British High Commissioner to Ghana, has presented two million rapid diagnostic kits to the Ministry of Health to help in the accurate and timely diagnosis of malaria.

Mr, Presenting the items, the Commissioner said he had been struck by Ghana’s strong track record of achieving successes in the health sector which other nations were yet to reach, which included the eradication of polio and guinea worm.

“Ghana has achieved 35 per cent reduction in infant deaths and an impressive 40 per cent increase in life expectancy”, he said.

“It is also at the forefront of starting a system of universal health coverage for its people and championing the rights of people with mental disabilities and supporting their needs,” he said.

The envoy appealed to Government to “finish the job of ending preventable deaths from pregnancy and childbirth, communicable diseases, and ensuring that all Ghanaians can have access to good quality health service.”

Mr Jones urged everyone who suspected they might have malaria to seek testing before taking treatment.

Receiving the kits, Ms Sherry Ayitey, Minister for Health, expressed her appreciation to the British Government for the assistance, adding that the kits would be distributed to health facilities in rural communities.

The Minister said Western, Central and the Northern Regions would receive many of the kits since they recorded high malaria cases.