IDRI Contributes to First Point-of-Care Chagas Disease Diagnostic for US

With Chagas disease becoming more prevalent in the United States, a diagnostic to quickly and easily detect infection is needed. Today, IDRI (Infectious Disease Research Institute) announces that a fusion antigen it developed and patented is being used as part of a Chagas disease diagnostic test created by InBios and recently approved by the U.S. Food & Drug Administration (FDA) for use in the United States. This marks the first point-of-care diagnostic test for Chagas disease available in the United States.

A leading source of heart disease in Latin America, Chagas disease caused by the parasite Trypanosoma cruzi. While transmission of Chagas disease most often takes place due to the bite of an infected member of the Reduviidae family of insects -- commonly called the "kissing bug" -- it can also occur via blood transfers and the disease has been globalized by vector-independent transmission. Although not endemic in the United States, conservative estimates are that Chagas disease-related healthcare costs are in excess of $118 million to the U.S. each year. Most predictions are that about 300,000 symptomatic cases exist in the U.S., although an alternative estimate suggests over one million more cases nationwide. California, Texas, Florida and New York likely each have over 10,000 cases and an additional seven states probably have over 5,000 cases.

Given the possibility of transmission by blood transfusion, blood and tissue products, national screening of the blood supply was instituted in the United States in early 2007. Now, through an assay developed using IDRI technology, tests will be available in the U.S. to detect Chagas disease infection in individuals.

"At IDRI, our goal is to develop products that are useful for diseases that are prevalent in the developing world, but more often we are seeing these diseases -- like Chagas -- become a threat in the developed world because of travel or vector-independent transmission, such as blood transfers," said Steve Reed, Ph.D., President, CEO & Founder of IDRI. "Rapid diagnosis is a key step in stopping infectious disease. We're pleased to play a key role in getting this diagnostic to people who might be affected by Chagas disease."

InBios' Chagas Detect Plus Rapid Test Kit (CDP) is a non-invasive diagnostic test for use in a primary care setting by personnel trained to obtain whole blood or serum samples. The two-step rapid diagnostic test is easy to use and results can be obtained in 20 minutes. In several clinical studies, the CDP demonstrated greater than 95 percent sensitively and specificity in both endemic and non-endemic populations.

Estela Raychaudhuri, President of InBios, said, "We are excited to bring this long awaited, fast and affordable point of care Chagas test to the U.S. market, developed in collaboration with the Infectious Disease Research Institute."

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Sekisui Diagnostics Announces Launch of OSOM® BVBLUE® Rapid Test for Bacterial Vaginosis in Europe, Middle East and North Africa

Sekisui Diagnostics announces the launch of the OSOM® BVBLUE® Test in Europe, Middle East and North Africa.  The OSOM® BVBLUE® Test, which is used in the diagnosis of bacterial vaginosis (BV), is now CE marked. The test provides accurate results with minimal hands on time through detection of elevated levels of the enzyme sialidase produced by the four major pathogens associated with the condition.

The OSOM® BVBLUE® Test, combined with the OSOM® Trichomonas Test, provide comprehensive diagnostic tools for two of the most common vaginal and sexually transmitted infections in the world. "Worldwide, it is estimated that 20 –30 % of women of reproductive age attending sexually transmitted infection (STI) clinics suffer from BV, the prevalence of which can be as high as 50–60 % in high-risk populations".

The OSOM® BVBLUE® Test delivers fast, accurate results in 10 minutes by utilizing a simple procedure with less than one minute hands on time. The ability to rapidly diagnose a BV infection is beneficial to the patient in order to begin immediate and proper treatment, while reducing the chance of serious health complications.

In studies, the OSOM® BVBLUE® Test demonstrated highly accurate results with 92.8% sensitivity and 98% specificity vs. Gram Stain, with the added benefit of objective result interpretation.  Along with the accuracy of the results, the OSOM® BVBLUE® Test provides economic benefits by helping to reduce the intensive labor and also the need for advanced expertise required to perform and interpret Gram Stains by microscopy.  

"Sekisui Diagnostics is committed to providing products that can have a direct impact on the improvement of patient care," says Lee Lipski, Vice President of Global Sales and Marketing, Sekisui Diagnostics.  "Building on the successful adoption of this test in the US, we are pleased to be able to offer the OSOM® BVBLUE® Test internationally, which now enables physicians and laboratories in those countries to offer simple and efficient testing for both bacterial vaginosis and trichomonas infections."

Along with these women's health products, Sekisui Diagnostics provides a broad line of OSOM® rapid tests for Influenza, Strep A, Mononucleosis, Helicobacter pylori, hCG and Faecal  Occult Blood.  Sekisui's Diagnostics expanding Point-of-Care product line also includes the FastPack® IP System, which offers a convenient, rapid, decentralized testing solution for Vitamin D, Testosterone, PSA, Free PSA, TSH, Free T4, and hCG.

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GenePOC to Announce CE Marking of Its Revogene™ Instrument and Its Second Test, CDiff

GenePOC, Inc., a member of Debiopharm Group, announced a new phase in its operations after obtaining CE marking for its revogene instrument and its first set of tests for Group B Streptococcus (GBS) and C. difficile. With this in place in addition to the European distributor network announced in November 2016, GenePOC is preparing for commercialization in Europe and other countries accepting CE mark for clinical diagnostics. The GenePOC team is proud to have reached this critical milestone.

"GenePOC has achieved another very important milestone for its future. By successfully combining the CE mark for the revogene instrument with 2 critical tests, GBS and CDiff, using complex clinical specimens and by obtaining very good clinical performance versus the reference methodology, GenePOC shows its ability to build a menu for infectious diseases, including Hospital Acquired Infections. This step, in line with our engagement, is only the first of a long series that will allow us to become a key actor in diagnosis at the point of service - and more precisely as close as possible to the patient," added Patrice Allibert CEO of GenePOC.

Further to the CE marking, clinical trials for the FDA on GBS have been completed and GenePOC expects the start of its CDiff clinical trial by mid-January.

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ID Genomics Launches National Consortium to Increase Rapidity & Accuracy of Infectious Disease Diagnosis

ID Genomics, Inc. announced the formation of a national consortium of clinical partners to help increase the rapidity and accuracy of infectious disease diagnosis and antibiotic treatment through the company's novel DNA-based "bacterial fingerprinting" diagnostics system. The initial consortium was formed under a grant from National Institutes of Health and includes the Group Health Cooperative, Seattle Children's Research Institute and Harborview Medical Center in Seattle; Los Angeles County Medical Center and Keck Medical Center of the University of Southern California in Los Angeles; NYU Langone Medical Center in New York City; and Hennepin County and Veterans Affairs Medical Centers in Minneapolis.

ID Genomics works with its consortium partners to catalogue genetic 'fingerprints' and antibiotic susceptibility of bacterial strains isolated from patients with active infections. These strains will expand the ID Genomics database and, thus, the test's diagnostic accuracy. The database will also provide localized data insights for clinical partners, highlighting unusual patterns of drug resistance or outbreaks.

The participation of consortium partners is critical to increasing ID Genomics' efficacy as a global resource for information on infectious disease agents and treatment options, and as such, the company is seeking additional clinics, labs and health care providers to join this global effort.

ID Genomics' proprietary technology is comprised of CLoNeT™, a rapid diagnostic test that assigns unique microbial DNA fingerprints to quickly determine the clonal identity of a bacterial strain in patient samples, and BactNeT™, a database that links CLoNeT™ fingerprints with responses to all commonly prescribed antibiotics. Together, they enable health care professionals to prescribe the most optimal antibiotic for a patient within half an hour, compared to the current 48-hour wait period.

"Each fingerprint link in BactNeT™ effectively tracks the medical history of different bacterial strains locally, nationwide or globally," said Evgeni Sokurenko, Professor of Microbiology at the University of Washington, Seattle, and Founder of ID Genomics. "This resource enables doctors to quickly and accurately recommend treatment plans, helping to save the lives of thousands of patients and reduce billions in medical costs associated with antibiotic resistance."

ID Genomics' revolutionary approach has been tested at the Group Health Cooperative in observational clinical trials, which show that the company's technology reduces the rate of empiric antibiotic treatment errors from almost 30 percent in some clinical categories to less than 5 percent. The process ensures that prescriptions are precisely tailored for both the patient and the infecting strain, and promotes antimicrobial stewardship by ensuring that antibiotics are used appropriately.

In addition to guiding the appropriate treatment regimen, BactNet™ can provide real-time epidemiological surveillance that is expected to track the spread and emergence of new and existing drug-resistant 'superbugs'. With its ability to respond to patient needs while simultaneously detecting global infection dynamics, the BactNet™ network is the first precision surveillance mechanism of its kind.

"The importance of having such a universal epidemiological surveillance resource linking bacterial DNA fingerprints with drug resistance profiles as part of point-of-care diagnostics can't be overstated," said James R. Johnson, M.D., who is Professor of Medicine at the University of Minnesota and an infectious diseases specialist at the Minneapolis VA Medical Center. "With this novel approach, the global health community will have a powerful new tool to rapidly diagnose, treat and contain the spread of multidrug-resistant bacteria, and also to identify drug-susceptible strains that can be treated safely with traditional, inexpensive antibiotics."

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New PCR Primer Database to Combat RNA Viral Epidemics

Korea’s Daegu Gyeongbuk Institute of Science and Technology (DGIST) scientists have compiled a comprehensive new public database of genetic information to enable the detection and identification of RNA viruses using the polymerase chain reaction (PCR) assay. The database should prove invaluable in combatting potential future epidemics.

RNA viruses, which contain ribonucleic acid as their genetic material, cause many infectious diseases including influenza, polio and measles. In recent years, new and fatal diseases due to RNA viruses have emerged, notably severe acute respiratory syndrome (SARS) and Middle East respiratory disease (MERS), both of which had severe health and economic impacts.

The SARS epidemic emerged in southern China 2002.  It killed 774 people in 37 countries, before its eventual control, while last year’s MERS outbreak in Korea resulted in an estimated 40% reduction in foreign tourism, adversely impacting the national economy.

In both cases, the disease spread rapidly due to the slow and unreliable diagnosis of the responsible virus. When such outbreaks occur, accurate pathogen detection and identification is essential, in order to understand and control the disease, thereby minimizing its effects on public health.

PCR, which involves amplifying a section of DNA to generate thousands or millions of copies of a particular DNA sequence, is widely used for rapid and accurate viral identification, thanks to its low cost but high sensitivity and specificity.

PCR uses ‘thermal cycling,’ which entails repeated heating and cooling of the reaction for DNA melting and enzymatic (polymerase) DNA replication. Primers comprising a short strand of DNA, usually 18-22 nucleotide bases long, serve as a starting point for DNA synthesis, with the enzyme DNA polymerase enabling selective, repeated amplification.

However, very few online databases have compiled high-quality PCR primers for RNA viruses and those that are available have certain limitations that restrict their usefulness.

To address this need, a research team led by Min-Soo Kim (Department of Information and Communication Engineering) and JaeHyung Koo (Department of Brain and Cognitive Sciences) at DGIST, have compiled a comprehensive new database of PCR primers, to enable the detection and identification of RNA viruses more rapidly and effectively. They reported their results in the November 29, 2016, edition of Nucleic Acids Research.

The new DGIST reference resource, the MTPrimerV database, contains 152, 380, 247 PCR primer pairs for the detection of 1,818 viruses, covering 7,144 gene-coding sequences or CDSs (from coding DNA sequence), which are the portion of a gene’s DNA or RNA that codes for a protein.

These in silico primers are capable of detecting 100% of the RNA viruses included in the latest U.S National Center for Biotechnology Information Reference Sequence (NCBI RefSeq) database, an open access curated collection of DNA and RNA nucleotide sequences and their protein products.

Due to rigorous similarity testing against all human and viral sequences, every primer included in the MRPrimerV database (http://MRPrimerV.com) is extremely target-specific.

“We believe that the public availability of MRPrimerV will facilitate viral metagenomics studies aimed at evaluating the variability of viruses, as well as other scientific tasks, facilitating effective responses to potential epidemics,” the DGIST researchers conclude.

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MilliporeSigma Acquires BioControl to Strengthen Position in Food Safety Testing

MilliporeSigma today announced it has acquired BioControl Systems Inc., a global leader in food safety testing. The acquisition opens growth opportunities for MilliporeSigma in the food and beverage space, particularly in the U.S. Confidentiality has been agreed on the financial details of the transaction.

BioControl's established rapid detection technology and third-party validated testing platforms complement MilliporeSigma's portfolio of instruments and consumables in its applied solutions business geared to the food pathogen testing workflow.

"BioControl's acquisition strengthens our ability to help customers protect the global food supply by providing an expansive portfolio of state-of-the-art testing technology," said Udit Batra , Member of the Executive Board of Merck KGaA, Darmstadt, Germany and CEO, MilliporeSigma. "BioControl's innovative assays and validated kits, when combined with MilliporeSigma's strengths in microbiology, filtration and e-commerce will create a strong global provider aimed at solving tough challenges in the food pathogen testing space."

The global spotlight on the importance of food safety has grown given the increased incidents of outbreaks and recalls with foodborne diseases often caused by consuming a wide range of foods including undercooked meat, eggs, fresh produce and dairy products contaminated by Salmonella, Listeria, E.coli O157H7 and Campylobacter. BioControl's product portfolio includes pathogen detection kits to identify these food poisoning bacteria in food and ingredients and its key customers include meat producers.

"MilliporeSigma is the best home for Biocontrol, our customers and our employees," said Phil Feldsine , President and Chief Executive of BioControl. "MilliporeSigma's global market presence as a leader in laboratory sciences will introduce BioControl's innovative, customer oriented solutions to a much broader base worldwide while providing existing customers with access to MilliporeSigma's food safety product portfolio and expertise. The opportunity for BioControl to become part of a world class 350-year-old organization with a reputation for doing it the right way is very rewarding."

The acquisition is in line with MilliporeSigma's strategy to expand in key geographies and provide a differentiated experience to customers in applied settings, including food and beverage safety testing. While the business will continue to focus on microbial quality control solutions for pharmaceutical production processes and products, an area where the business currently has leading market share, the acquisition will enable MilliporeSigma to offer a complete food pathogen testing platform to its customers in the food and beverage safety testing market.

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