Saturday, November 29, 2014

British-Led Scientists Trial 15-minute Ebola Test in Guinea

British scientists announced trials on a 15-minute Ebola test in Guinea as French President Francois Hollande became the first Western leader to visit a country devastated by the epidemic.

The prototype is six times faster than current tests and aims to speed up diagnosis, the London-based global research charity Wellcome Trust and Britain's Department for International Development (DFID) said in a statement.

"A reliable, 15-minute test that can confirm cases of Ebola would be a key tool for effective management of the Ebola outbreak, allowing patients to be identified, isolated and cared for as soon as possible," said Val Snewin of the Wellcome Trust.

She said the test was designed to be suitable for remote field hospitals where electricity and cold storage are often scarce.

The trials, to be led by researchers from Dakar's Pasteur Institute at an Ebola treatment centre in Conakry in the coming weeks, will come as a welcome boon in Guinea which has lost 1,200 people to Ebola.

The biggest Ebola epidemic on record has claimed around 5,700 lives in Guinea, Liberia and Sierra Leone since the beginning of the year, according to the World Health Organization.

President Hollande pledged his support for Guinea after arriving in France's west African former colony on Friday.

He said he was bringing with him a message of solidarity to healthcare workers who "take risks to ensure the highest quality care", and a message of confidence, because "it was very important to tell the world that Guinea is still alive, still fighting".

He also wanted to call for vigilance, he said, because "the battle against Ebola isn't won".


- 'Very important sign -


The visit is the first by a French president since 1999, and comes after France pledged 100 million euros ($125 million) towards the fight against the epidemic in Guinea.

The money will help finance several care centres as well as 200 beds, some of which are reserved for health workers caring for the sick.

France has also pledged to set up two training centres for health workers, one in France and one in Guinea. In addition, French biotechnology companies will set up rapid diagnostic tests in Africa.

Hollande visited healthcare workers at Conakry's Donka hospital, which hosts the city's Doctors Without Borders Ebola treatment unit, alongside his Guinean counterpart Alpha Conde.

Before entering, both men followed the protocol of washing their hands and having their temperatures taken.

The French leader is also due to sign a cooperation agreement with Guinean authorities for the creation of a Pasteur Institute in Conakry by the end of 2016, the global medical research organisation said on Thursday.

"For the people of Guinea, the arrival of President Hollande is a very, very important sign," Conde said.

"If the president of a country as important as France can come to Guinea, that means anyone can come to Guinea."


- Heightened tensions -


The visit comes amid heightened tensions in Guinea over the government's handling of the Ebola crisis and criticism over curbs to free speech.

Conde said on Wednesday the use of force was entirely justified in battling the deadly Ebola outbreak.

"There are still people who think Ebola is fiction," Conde told a news conference in a country where an eight-member Ebola education team was murdered by angry villagers in September.

"We have an agenda which is to finish with Ebola as soon as possible and in Guinea this is possible," he added.

"If people don't want to be treated we will use force because we won't allow the illness to spread despite all our efforts."

Press advocacy organisation Reporters Without Borders has voiced concern about the attacks on press freedom under the pretext of the fight against Ebola.

Meanwhile the Guinean opposition coalition this week denounced the lack of consultation by the government over its strategy for fighting Ebola.

Hollande travelled to the Senegalese capital Dakar later on Friday to take part in a summit of French-speaking leaders that is likely to be dominated by the Ebola crisis as well as the recent unrest in Burkina Faso.

Hollande told a cheering crowd in Conakry that he would "launch a new appeal for international mobilisation. But France must lead by example".

The Federation of Red Cross and Red Crescent Societies urged the international community to refrain from "complacency" despite signs that the epidemic is stabilising in Guinea and Liberia.

"The progress made in the fight against Ebola must be regarded as confirmation that our collective approach is successful and encourage us to stay the course until the epidemic is really under control," said Elhadj As Sy, the head of the organisation.

In a separate development, Mali announced on Friday that it had, for the first time, successfully treated a patient with the virus.

"We announce the first case of treating a person with Ebola virus. This person was treated effectively," said Health minister Ousmane Kone at a press conference.

Wednesday, November 26, 2014

Romer Labs’ RapidChek Listeria NextDay AOAC Certification is Extended for Monitoring Food Samples

Romer Labs announced that its RapidChek® Listeria NextDay™ test system earned Performance-Tested MethodsSM (PTM) certification from the AOAC Research Institute for various ready-to-eat foods with a 27-48 hr. enrichment. The AOAC PTM certification extension for food samples validates RapidChek Listeria NextDay™ as equivalent to the USDA Food Safety Inspection Service’s (FSIS) 48-hour methodology for detecting all 6 Listeria species on food samples, including hot dogs, roast beef, frozen breaded chicken and meatballs and equivalent to the FDA BAM 48-hour methodology for various dairy products.  The RapidChek Listeria NextDay™ system had previously received AOAC PTM certification for monitoring environmental surfaces, including stainless steel, rubber, plastic and concrete under the brand name RapidChek Listeria F.A.S.T. ™.

According to the USDA FSIS, dozens of food product recalls within the last 3 years could have been prevented if the industry routinely followed the “test and hold” practice.  With “test and hold” now in place, many processors are moving from traditional 40-48 hour Listeria methods to faster rapid methods due to storage and spoilage costs.  The NextDay™ system is designed to provide food processors with the benefits of reduced material and processing costs as well as enhanced workflow and reduced time-to-results to meet these needs.

Michael Prinster, CEO at Romer Labs North America, said, “The extension of our AOAC-PTM certification for the RapidChek Listeria NextDay™ system will allow processors and testing labs to obtain next-day results for ready-to-eat food samples using the same cost-effective, accurate test system that has successfully been implemented in many facilities around the world for environmental samples.  RapidChek® Listeria NextDay™ will enable food processors to reach results faster, without comprising accuracy.  We are very pleased with this AOAC certification and believe that our test system will serve to further strengthen Romer’s position in the pathogen testing market.”

Tuesday, November 25, 2014

Thermo Fisher Scientific and Samsung Electronics to Collaborate on Point-of-Care Diagnostic Solutions

To answer the healthcare industry’s demand for better point-of-care (POC) diagnostics, Thermo Fisher Scientific Inc. and Samsung Electronics Co., Ltd. have formed a strategic collaboration. The companies will jointly design, develop and market new POC solutions in key applications, such as the detection of sepsis, drugs of abuse and therapeutic drug monitoring as well as the detection of cardiac problems and women’s health conditions.

“Samsung has developed a compelling and innovative suite of POC platforms,” said Marc Tremblay, Ph.D., president of Thermo Fisher’s clinical diagnostics business. “We look forward to working with Samsung to add some of our leading biomarkers and assays to their platforms to create a truly differentiated testing menu.”

“We are very excited to leverage Thermo Fisher Scientific’s strong commercial sales and service channels, as well as the potential to offer a broader range of tests to our customers and their patients,” said Soo-In Cho, president and head of the health & medical equipment business at Samsung. “This strategic collaboration combines the strengths of two industry leaders to accelerate POC innovation and more rapidly bring solutions to market.”

According to the National Institutes of Health (NIH), POC testing enables patient diagnoses in a physician’s office; an ambulance; anywhere in the field, including a home; or in a hospital. This facilitates more rapid diagnosis and treatment. In its “fact sheet,” the NIH writes: “Empowering clinicians to make decisions at the ‘point-of-care’ has the potential to significantly impact health care delivery and to address the challenges of health disparities.” (See http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112)

Monday, November 24, 2014

TECHLAB Develops Diagnostic for Tropical Disease

Vacationers might spend time finding the perfect souvenir to remember a trip. One thing they don’t want to bring home, however, is Montezuma’s Revenge.

According to the Centers for Disease Control, diarrhea is the most common travel-related illness, afflicting 30 to 70 percent of travelers. Unfortunately, there can be many different causes for diarrhea, with varying degrees of seriousness. Bacteria or viruses can make you feel sick within hours, but usually pass after a few days. Those who contract a parasite may not get sick for a week or two, but symptoms can persist for months. Without proper treatment, this kind of diarrhea is dangerous—even deadly.

TECHLAB®,Inc. (“TECHLAB”), a Blacksburg-based medical diagnostics firm, has developed a fast, easy-to-use diagnostic kit to identify Entamoeba histolytica, a protozoan parasite that can be acquired in many tropical and sub-tropical locales.

“Entamoeba histolytica infects an estimated 50 million people worldwide, causes not just diarrhea, but also colitis and liver abscesses, and is responsible for an estimated 100,000 deaths each year,” Tracy WilkinsCharlie Pennington, TECHLAB president, said.

The TECHLAB® E. HISTOLYTICA QUIK CHEK™ test is non-invasive and takes only 30 minutes to get results. The E. HISTOLYTICA QUIK CHEK™ test recently received the CE Mark for sale outside of the United States; review by the FDA for domestic distribution is pending. The test is quick and easy to read, requires no extra instrumentation, and provides sensitivity comparable to more labor-intensive techniques.

The E. histolytica parasite is difficult to diagnose because it resembles Entamoeba dispar, which does not cause disease. The TECHLAB® E. HISTOLYTICA QUIK CHEK™ test (“E. HYSTOLYTICA QUIK CHEK”) is the first rapid antigen test available that differentiates between E. histolytica and E. dispar. Other diagnostic methods that differentiate between the two organisms take hours to get results.

E. histolytica can be treated easily with oral antibiotics, while its look-alike, E. dispar, does not require treatment. Overprescribing antibiotics is dangerous for patients due to potential side effects and growing concerns about antibiotic resistance.

“Our newest diagnostic kit is a novel tool in the worldwide fight against diarrheal diseases,” Pennington said. While parasitic diarrhea is an uncomfortable and inconvenient affliction for adult travelers, it can be fatal for children who live in the developing world. “The diseases that cause diarrhea are preventable, but a few bouts of moderate diarrhea can cause cognitive impairment, growth stunting, and even death for children living in unsanitary conditions,” Pennington said. “We hope E. HISTOLYTICA QUIK CHEK can help travelers, but more importantly, we hope it can help improve global health.”

“E. HISTOLYTICA QUIK CHEK is an advancement for worldwide healthcare, but it is also an achievement for our local community. The test was developed and is manufactured in the New River Valley. The project has brought jobs and infrastructure improvements to the region,” David Lyerly, TECHLAB vice president of research and development, said.

Joel Herbein, TECHLAB senior research scientist and principal investigator for the E. HISTOLYTICA QUIK CHEK project, describes the importance of industrial-academic partnerships in producing medical diagnostics: “The TECHLAB launch of the E. HISTOLYTICA QUIK CHEK is a celebration of regional and international cooperation.” TECHLAB collaborated with William A. Petri, Jr.’s expert E. histolytica research team at the University of Virginia and Rashidul Haque’s clinical study site in Dhaka, Bangladesh, an area where E. histolytica is endemic. “Based on the combined strength of TECHLAB as a profitable manufacturer and a world renowned research group, we were able to secure $4.5M in biodefense initiative small business grants from the National Institutes of Health to help support the project,” Herbein said.

Founded in 1989, TECHLAB® Inc. is a global leader in developing and manufacturing premium diagnostics for diarrheal diseases. TECHLAB research teams focus on enteric diseases and the microbiology of the intestinal tract. TECHLAB offers diagnostic kits for colitis, parasitology, intestinal inflammation, and Shiga toxins. Headquartered in Blacksburg, Virginia, TECHLAB is dedicated to excellence in its diagnostics and research. TECHLAB diagnostic kits are available through its distributor and partner, Alere™, a leading global provider of diagnostic products and health information solutions. Together, TECHLAB and Alere provide high quality, rapid diagnostics for your enteric needs.

Chembio Signs Agreement With CDC Contractor to Develop a Multiplex Point-of-Care Test for Influenza Immunity

Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has entered into a follow-on, milestone-based development agreement with a private contracting organization acting on behalf of the United States Centers for Disease Control and Prevention (CDC), for a multiplex POC influenza immunity test utilizing Chembio's patented Dual Path Platform (DPP®) technology.

As a result of pandemic planning activities, the United States Department of Health and Human Services (HHS) and the CDC identified POC and high-throughput testing as a gap in influenza diagnostics. Rapid responses in the field — such as the vaccination, prophylactic treatment or isolation of patients — require POC diagnostic tests for influenza infection and immunity. Ideally, these tests should be fast, portable, self-contained and non-technical.

John Sperzel, Chembio's Chief Executive Officer, commented, "We are pleased to continue with this development program, which builds upon our experience and expertise developing multiplex POC assays using our proprietary DPP® technology, and we are pleased that the CDC and its contracting partner continue to see value in our DPP® technology. Our innovative and versatile DPP® technology is ideally suited to rapidly test for multiple influenza immunities, where rapid access to this information can guide treatment decisions and help avert widespread outbreaks."

The prior development work for a DPP® Influenza Immunity Assay was completed by Chembio between 2010 and 2013, pursuant to previous contracts with the same organization. The current project is being funded by the same organization and contemplates a timeline of three months to optimize the multiplex POC DPP® Influenza Immunity Assay to determine a person's influenza immunity status in the field or in an outpatient setting, while incorporating certain additional subunits of influenza virus proteins.

Thursday, November 20, 2014

i-calQ Receives U.S. Patent for Smartphone-Based Method of Rapid Diagnostic Testing

i-calQ LLC today announced that the United States Patent and Trademark Office has granted the company a patent for a method to test “biological samples and body fluids” using an inexpensive smartphone attachment to “quantify, interpret, and record point of care diagnostic testing, creating, in essence, a low cost, portable, easy to use system that can replace the traditional medical laboratory.”

i-calQ’s patented, low-cost technology consists of disposable test strips, a universal reader attachment that is compatible with all makes and models of smartphones, and a decision support app that reads quantitative results from disposable test strips, provides rules-based expert algorithm support to interpret the results and recommends additional testing, treatment, and follow-up. The app automatically prints the results and transmits the results using either mobile data network or wireless internet connection to a cloud database or electronic medical record.

Joel Ehrenkranz M.D., i-calQ’s chief medical officer, begin innovating in the field of smartphone-based point of care diagnostics while working in an Ebola epidemic in Uganda in 2007. He recognized how the inability to promptly diagnose Ebola was costing lives and allowing the epidemic to spread.

Seeing the potential for convergence of mobile phone technology and modern medicine to help control the 2007 Ebola outbreak, Dr. Ehrenkranz foresaw how smartphones could become an essential platform for the next generation point-of-care diagnostics.

“In the most remote part of Uganda where very little worked, mobile phones did,” Dr. Ehrenkranz said. “It suddenly became obvious that the essential features of mobile phones could be used as portable clinical laboratories to test and interpret results and transmit this information to a centralized public health database. In 2007 it was an just an idea, but in 2014, it is reality.”

Promoting Cost-Effective Health Care

i-calQ’s technology can increase the penetration of public health surveillance, bringing specialist expertise to anywhere a smartphone goes, be it be a remote medical clinic or the privacy of a patient’s home.

i-calQ’s technology also has positive implications for the health and fitness of Americans who are concerned about changes in medical services and costs.

In addition to professional medical applications, personal biometric monitoring using i-calQ’s technology can be used to monitor nutrition, fitness, stress, and fertility. i-calQ’s technology can be used to identify whether a particular vitamin or supplement might be beneficial and the correct dose to take.

“If used wisely, these tests could reduce the number of doctor visits, lower insurance and medical costs, help individuals improve their health and fitness, and give consumers some control over their healthcare options,” explains Pamela Turbeville, CEO of i-calQ.

Monday, November 17, 2014

FDA OKs Army's Diagnostic Tool for Skin Disease

Army scientists at Fort Detrick are hailing the Food and Drug Administration's approval of a tool they helped develop for rapidly diagnosing a disfiguring skin disease caused by sand fly bites in the Middle East.

The U.S. Army Medical Research and Materiel Command said Friday that the hand-held dipstick can produce results within 30 minutes. The previous method depended on laboratory tests of skin-lesion samples that often had to be shipped to the United States.

Lt. Col. Jeanne Norwood says rapid diagnosis means quicker treatment for the disease, called cutaneous leishmaniasis.

Leishmaniasis is a parasitic disease that is found in parts of the tropics, subtropics, and southern Europe. It is classified as a Neglected Tropical Disease (NTD). Leishmaniasis is caused by infection with Leishmania parasites, which are spread by the bite of phlebotomine sand flies. There are several different forms of leishmaniasis in people. The most common forms are cutaneous leishmaniasis, which causes skin sores, and visceral leishmaniasis, which affects several internal organs (usually spleen, liver, and bone marrow).

The Army says the disease affects millions worldwide, including U.S. service members. The World Health Organization reported a major outbreak in Afghanistan in 2010.

The device is made by Seattle-based InBios International Inc.

Friday, November 14, 2014

Test Developed for Rapid Diagnosis of Bloodstream Infections

A  new bloodstream infection test created by Univ. of California, Irvine (UCI) researchers can speed up diagnosis times with unprecedented accuracy, allowing physicians to treat patients with potentially deadly ailments more promptly and effectively.

The UCI team, led by Weian Zhao, assistant professor of pharmaceutical sciences, developed a new technology called Integrated Comprehensive Droplet Digital Detection. In as little as 90 mins, IC 3D can detect bacteria in milliliters of blood with single-cell sensitivity; no cell culture is needed.

The work appears online in Nature Communications.

“We are extremely excited about this technology because it addresses a long-standing unmet medical need in the field,” Zhao said. “As a platform technology, it may have many applications in detecting extremely low-abundance biomarkers in other areas, such as cancers, HIV and, most notably, Ebola.”

Bloodstream infections are a major cause of illness and death. In particular, infections associated with antimicrobial-resistant pathogens are a growing health problem in the U.S. and worldwide. According to the Centers for Disease Control & Prevention, more than 2 million people a year globally get antibiotic-resistant blood infections, with about 23,000 deaths. The extremely high mortality rate for blood infections is due, in part, to the inability to rapidly diagnose and treat patients in the early stages.

Recent molecular diagnosis methods, including polymerase chain reaction, can reduce the assay time to hours but are often not sensitive enough to detect bacteria that occur at low concentrations in blood, as is common in patients with blood infections.

The IC 3D technology differs from other diagnostic techniques in that it converts blood samples directly into billions of very small droplets. Fluorescent DNA sensor solution infused into the droplets detects those with bacterial markers, lighting them up with an intense fluorescent signal. Zhao said that separating the samples into so many small drops minimizes the interference of other components in blood, making it possible to directly detect target bacteria without the purification typically required in conventional assays.

To identify bacteria-containing droplets among billions of others in a timely fashion, the team incorporated a 3-D particle counter developed by UCI biomedical engineer Enrico Gratton and his colleagues that tags fluorescent particles within several minutes.

“The IC 3D instrument is designed to read a large volume in each measurement, to speed up diagnosis,” Gratton said. “Importantly, using this technique, we can detect a positive hit with very high confidence.”

A UCI spinoff, Velox Biosystems, is now further developing the IC 3D technology.

Cepheid Receives Grant to Develop Ebola Diagnostic Test

Molecular diagnostics company Cepheid said it received a grant of up to $3.3 million, co-financed by the Paul G. Allen Family Foundation and the Bill & Melinda Gates Foundation, to develop a diagnostic test for the deadly Ebola virus.

The Xpert Ebola test, which is expected to use saliva or a drop of blood to identify the virus, is likely to be offered on an emergency use only basis, Cepheid said on Thursday.

Cepheid and the Gates Foundation are also evaluating deploying the company's RemoteXpert cloud-based monitoring software to help track the spread of the disease.

Cepheid joins a list of diagnostic makers looking to develop tests to accurately and quickly detect Ebola, which has killed more than 5,000 people so far.

The U.S. Food and Drug Administration last month granted emergency authorization to two new Ebola diagnostic tests made by BioFire, a subsidiary of medical diagnostics maker BioMerieux .

Salt Lake City-based BioFire's tests can detect Ebola in blood or urine samples in one hour, a significant improvement on the 24 to 48 hour time frame that currently available tests take to pinpoint the disease.

Chembio Diagnostics Inc said last month that it had begun developing point-of-care diagnostic tests for Ebola and febrile illness in partnership with privately held Integrated BioTherapeutics Inc.

Monday, November 10, 2014

PositiveID Corporation Signs Agreement With U.S. Special Operations Command

PositiveID Corporation, a developer of biological detection and diagnostics solutions, announced today that it has signed a U.S. Special Operations Command ("USSOCOM") Cooperative Research and Development Agreement ("Agreement") with Special Operations Research, Development, & Acquisition Center, Science & Technology Directorate ("USSOCOM SORDAC-ST"), to further develop the Company's real-time PCR (polymerase chain reaction) pathogen detection system, Firefly Dx, for use across the USSOCOM mission space.

PositiveID's Firefly Dx is a point-of-need, handheld system designed to deliver molecular diagnostic results using real-time PCR chemistry. Firefly Dx is being developed to meet the growing need in military and healthcare markets for more rapid and accurate point-of-need diagnostics that will enable hospitals, physicians, deployed military personnel, and others to save lives. Firefly Dx is designed to derive results from a sample in less than 20 minutes, at the point of need, compared to two to four hours for a laboratory-based device, which could enable accurate diagnostics leading to more rapid and effective treatment at the point of care than what is currently available or non-existent with existing systems.

The objective of this Agreement is to provide a foundation for cooperative work between USSOCOM SORDAC-ST and PositiveID to continue the development of Firefly Dx for Special Operations Force ("SOF") applications, and to provide enhanced operational capability to USSOCOM assets. PositiveID will receive requirements, priorities, feedback, and human factors/human systems integration support to facilitate its ability to support SOF technology needs.

William J. Caragol, Chairman and CEO of PositiveID, said, "We are very proud to work in partnership with the Department of Defense and USSOCOM to help fill their need for novel technologies and systems that can be used to safeguard those who protect our country. We intend to utilize their expert guidance as we continue to develop the prototype of Firefly Dx."

FIND and QuantuMDx Partner to Develop Rapid Genome-based Diagnostics for Tuberculosis

FIND, a Geneva-based non-profit organization, is joining forces with UK diagnostics developer QuantuMDx Group to develop a combined solution for the rapid detection of tuberculosis and determination of drug resistance.

The time for full drug resistance profiling will be reduced from a week to less than half an hour based on the molecular detection of an extensive set of genetic markers by the simple handheld Q-POCTM device developed by QuantuMDx.

The uniqueness of the nanowire technology developed by QuantuMDx provides the potential to interrogate the bacterial genome with unprecedented precision, as it allows not only targeted detection of specific markers, but in addition (in a future evolution of the present system) genetic sequencing on the same technology platform.

Under the partnership, FIND is supporting the development of an appropriate and integrated sample handling compartment, while QuantuMDx continues its platform development.

Catharina Boehme, FIND’s CEO noted that "after an extensive screening of different Point-of-Care platform solutions amenable to the decentralized testing for tuberculosis, we concluded that QuantuMDx’s Q-POCTM system provides a unique set of capabilities which allows for the seamless integration of future genetic discoveries and hence will assure a long-term sustainability of the molecular testing approach for tuberculosis."

Elaine Warburton, CEO of QuantuMDx said, “Our strategic partnership with FIND is of immense importance to QuantuMDx. It not only affords us a wealth of experience and expertise in developing and commercializing a much-needed diagnostic device for developing countries, but also provides independent validation of our strongly held belief that the provision of low cost, truly point of care molecular analysis for speciation and drug susceptibility status is a practical and effective tool in helping support the early identification and eventual eradication of MDR-TB and other infectious disease humanitarian health challenges.”

Jonathan O’Halloran, QuantuMDx’s CSO and Q-POCTM inventor added, "Excitingly, our partnership with FIND will support us in navigating the complexities of commercializing a diagnostic device. Furthermore, with networked Q-POCsTM deployed in the field throughout the world we will have an early warning platform to monitor novel pathogens and emerging hotspots of drug resistance in real-time; a concept we like to call the Internet of Life."

Wednesday, November 5, 2014

MBio Diagnostics Awarded Contract for Diagnostic Development With the U.S. Army

MBio Diagnostics, Inc. announced today it was awarded a three-year development contract with the U.S. Army's Walter Reed Army Institute of Research (WRAIR) for the "Development of a Ruggedized Portable Cartridge Reader for Malaria Diagnosis."

Under this contract, MBio Diagnostics will develop a low cost, multi-analyte "point-of-care" (POC) diagnostic device for malaria with enhanced sensitivity, quantitation capabilities, and automated data capture and transmission, using the company's planar waveguide LightDeck® technology. The work will be carried out collaboratively with Dr. John Waitumbi of the United States Army Medical Research Unit-Kenya (USAMRU-K), which is a "Special Foreign Activity" of the WRAIR headquartered in Nairobi, Kenya. The USAMRU-K unit develops and tests improved means for predicting, detecting, preventing, and treating infectious disease threats important to the U.S. Military as well as conducts surveillance, training, research and response activities related to emerging infectious diseases threats.

Commenting on the contract, Chris Myatt, CEO of MBio Diagnostics, said, "We are thrilled to be working with Dr. Waitumbi and his team at Walter Reed's USAMRU-K unit to develop a key diagnostic for use in regions where malaria is endemic. This fits naturally with our infectious disease program, where we focus on diagnostics for HIV, influenza, and hemorrhagic fevers."

"We are looking for a high-quality diagnostic device that would strengthen monitoring and early care of deployed US Service Members and civilians in areas where malaria is endemic," said Colonel Rodney Coldren, Director of the Department of Emerging Infectious Diseases at USAMRU-K. "This contract begins the process of analysis and development."

It is estimated by the World Health Organization that malaria causes more than 600,000 deaths annually, with 90 percent of those occurring in Africa. Development of medical products for infectious diseases requires access to study populations in field sites where the disease agents are endemic as well as access to clinical trials centers capable of conducting high quality and regulated vaccine and therapeutic trials. Specifically, malaria, HIV/AIDS, enteric pathogens, influenza, hemorrhagic fever viruses, and arthropod-borne diseases are among the most important of the militarily-relevant infectious agents.

To date, malaria rapid diagnostic tests (RDTs) have significant limitations. MBio's planar waveguide technology has a needed and unique ability to combine sensitivity, quantitative analysis, batch processing, automated data capture and transmission, as well as ability to configure for a panel of febrile illnesses.

Tuesday, November 4, 2014

WholeHEALTH Products Announces Completion of its Global Distribution Rights for the Real Time PCR Rapid Ebola Test

WholeHEALTH Products will market its PCR Rapid Ebola Test directly to Africa and South American countries, while WholeHEALTH applies for FDA Emergency Use Approval (EUA) for the US market shortly.

The WholeHEALTH Products PCR Rapid Diagnostic Ebola Whole Blood Test can be done in 3 hours—a vast improvement over waiting days with the present testing.

WholeHEALTH Products' experienced CSO worked with China on the SARS virus, developed a Rapid Diagnostic Test for the H1N1 (Bird Flu), and is heading up the completion of the Rapid Real Time PCR Diagnostic Test for Ebola.

Some fever screening will begin, but the need for a rapid diagnostic test is paramount for airports, once a person has been detected to have a fever.  The fever is not the issue; the airports need to find out right away if this person has Ebola so further testing, quarantine and emergency care issues can be addressed.

WholeHEALTH Products' soon-to-be announced Rapid 15 Minute Lateral Flow Ebola Diagnostic Test will do just that; it will determine with 99% accuracy if the person has Ebola.  Once WholeHEALTH Products completes its Phase 3 in-house study, it will file for the EUA (Emergency Use Approval) for this test as well.

As of 10 October 2014, Africa has reported 8,376 suspected cases resulting in the deaths of 4,024.  Although the Ebola death rate is alarming, the possibility of the virus spreading is ultra critical.  There are several other viruses that kill hundreds of thousands or millions of people throughout the world, such as Dengue Fever, Malaria, HIV, and TB, but the spread of these diseases is not as easy as the spread of the Ebola virus.

Accelerate Diagnostics Announces Research Collaboration With CDC for Early Detection of Antibiotic-Resistant Biothreat Agents

Accelerate Diagnostics, Inc., an in vitro diagnostics company dedicated to providing solutions for the global challenge of drug resistant organisms, today announced that it has entered into a research collaboration with the Rapid Antimicrobial Susceptibility Testing Laboratory at the U.S. Centers for Disease Control and Prevention (CDC) to develop tests for the rapid analysis of antibiotic-resistant biothreat agents based on Accelerate's high-speed identification and antibiotic susceptibility testing platform.

Bacterial, biothreat agents and diseases such as anthrax, tularemia and plague pose significant national security and public health risks. While infections with these pathogens are rare in the United States, they can be disseminated or transmitted from person-to-person and result in high mortality rates. They therefore require special public health preparedness and surveillance so that any potential biothreat activity or disease outbreaks can be rapidly identified and contained. Early detection, isolation and treatment with effective antibiotics are critical to cure patients and limit the spread of disease.

Unfortunately, conventional testing methods available in hospital and public health labs can take several days to produce results. These methods are therefore unable to provide critical, time sensitive information to the healthcare community, denying caregivers the opportunity to manage infection and prevent outbreaks at the earliest stage.

Accelerate Diagnostics is developing a fully integrated, easy-to-use platform that provides high-speed identification and antibiotic susceptibility testing of pathogens, working directly from patient samples. The platform enables laboratories to provide critical microbiology results in hours instead of days.

As part of the collaboration with the CDC laboratory, Accelerate Diagnostics will use its expertise to develop assays for rapid identification of key bacterial biothreat agents, their virulence markers, and their antibiotic susceptibility and resistance profiles. The CDC will provide scientific expertise on the microbiology and molecular biology of biothreat agents, and will evaluate and optimize the performance of the platform, using its collection of biothreat agents. As part of the agreement, the CDC has purchased the Accelerate ID/AST platform for use in their laboratory.

"Early detection of highly infectious bacteria, including biothreat agents, and determination of their susceptibility to specific antibiotics are essential for patient management and protection of public health," said Larry Mehren, CEO of Accelerate Diagnostics. "We are honored and highly motivated to be working with the CDC on this critical public health and national security project."

Saturday, November 1, 2014

New Cystic Fibrosis, TB & Pneumonia Breathalyzer Test Proves To Be Fast, Inexpensive

Santa Fe, New Mexico based startup Avisa Pharma Inc. is a clinical stage company established in 2010 to develop and commercialize a new technology invented by Dr. Graham Timmins, Avisa’s Co-founder/Chief Science Officer and a University of New Mexico College of Pharmacy Associate Professor, who was assisted by colleagues from UNM’s School of Medicine. STC.UNM (STC), the technology-transfer arm of the University of New Mexico (UNM), has signed an exclusive option agreement with Avisa Pharma to license Dr. Timmons’s cystic fibrosis (CF) technology, the first rapid, biomarker-based, point-of-care breath test for the detection of serious bacterial lung infection. This breakthrough breath test technology combines two key components: AV-U13 inhalable urea solution with Avisa’a portable AVISAR SPEC (laser spectrophotometer). The AV BreathTest assesses infection in the entire lung within minutes.

Avisa’s development program objective for the breath test is to tailor the technology into a diagnostic tool for rapid monitoring of lung Pseudomonas infection and its response to antibiotic treatment in diseases such as CF. In addition to the CF related technology, Avisa has also entered into an agreement to exclusively license similar technology for Tuberculosis (TB). Both the CF and TB technologies are supported by issued patents. The follow-on targets are pathogens associated with healthcare-acquired pneumonia (HCAP), ventilator-associated pneumonia (VAP) and cystic fibrosis (CF).

Rapid detection of serious lung infections is highly desirable to improve patient outcomes, yet current techniques suffer from a number of key difficulties: Analysis often takes a long time, with bacterial cultures requiring many hours to several days. Furthermore, molecular diagnostics cannot measure the whole lung, cannot distinguish colonization from infection, are not point-of-care, and cannot monitor therapy.

Avisa observes that rapid identification of serious lung infection, such as tuberculosis, is a critical medical and public health challenge worldwide, and that rapid, point-of-care detection of these infections would significantly improve clinical outcomes and lower healthcare costs, saving millions of lives and millions of dollars worldwide.

CF patients have a genetic defect causing excessive thick mucus in their lungs that leads to chronic lung infections. Currently, no fast, effective test is available to monitor lung microbiology and response to therapy in cystic fibrosis, yet being able to do this could greatly benefit people with the disease. Avisa’s vision is to develop a diagnostic tool for Pseudomonas that would significantly improve CF management. Early, aggressive treatment of CF lung infections improves prognosis, but most CF infections are not treated until they cause increased symptoms (and more lung damage). Avisa’s technology addresses this vital gap in CF treatment by providing a rapid, point-of-care diagnostic technique.

The technology developed by Dr. Timmins and Avisa assesses the bacterial load in the entire lung by measuring exhaled labeled carbon dioxide that is produced by the bacterial metabolism of an inhalable, pharmaceutical grade, synthetic urea labeled with 13C stable non-radioactive isotope of carbon — AV-U13 — the tracer component of the breath test.

Most serious lung pathogens make urease, a unique bacterial enzyme, to convert our body’s natural urea into carbon dioxide and ammonia. The AV BreathTest exploits this reaction to detect these pathogens in the lung. AV-U13 is administered to the patient through a nebulizer in minutes, where it is metabolized in the lung by P. aeruginosa to 13CO2, which is then exhaled and easily and sensitively measured. The amount of 13CO2 exhaled is a function of the amount of infection in the lung, detected by the AVISAR spectrophotometer.



The Avisa technology is based on the labeling of a substrate that is metabolized only by bacteria and gives off CO2. It delivers the substrate directly to the lungs and measures the exhaled breath for the release of labeled CO2 which is the measure of bacterial presence. The mechanism of action utilizes detection predominantly based on known virulence factor through the use of stable, non-radioactive isotopically labeled compound breath tests of exhaled carbon dioxide for disease inducing pathogens.

A similar approach to testing exhaled breath for stable isotopes to measure bacterial colonization has been successfully used for detecting and treating H. pylori in patients with ulcers. Avisa notes that stable isotope breath testing has been a real-game changer in rapid detection and management of H. pylori infection; and they want to do the same for CF and TB.

The entire breath test process reports on urease-expressing lung pathogens from the increase in exhaled 3CO2 within minutes at the point-of-care whether it is a hospital, clinic, or out in the field.

“The sooner we can diagnose if somebody’s ill or not,”Dr. Timmins told KOAT-TV Albuquerque’s Angela Brower, “the sooner we can intervene with the right kind of drug therapy, and the sooner those people are not going to be transmitting TB.”

Avisa says AV BreathTest advantages include:

• Detection of bacteria throughout the entire lung
• Delivers results in minutes
• Ultra-portable and battery-powered device can work wherever needed
• No radioactive compounds are ever used

The AVISAR SPEC (laser spectrophotometer) is a rugged, portable device that rapidly measures breath13CO2/12CO2 isotope ratios. The AVISAR SPEC uses unique IR spectroscopic detection to enable a compact, battery-powered unit weighing about 8 pounds (4 kg). AVISAR SPEC’s rugged, portable design allows it to be as easily carried to remote sites in a backpack as it is around clinics or hospital departments.

Source: Cystic Fibrosis News Today

Chembio's DPP(R) HIV 1/2 Assay Receives CLIA Waiver From FDA

Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests and technology, today announced that the U.S. Food and Drug Administration (FDA) granted a CLIA Waiver for the Company's DPP® HIV 1/2 Assay. Chembio's DPP® HIV 1/2 Assay was FDA-approved previously, and the CLIA Waiver will allow Chembio to expand into important new channels that are closest to patient care including physician-office-lab (POL) facilities, clinics and other community healthcare providers.

Chembio's DPP® HIV 1/2 Assay detects HIV antibodies in oral fluid or blood and uses the Company's patented Dual Path Platform (DPP®) technology, which offers excellent sensitivity and specificity. The product's unique SampleTainer® specimen collection bottle is a safe, closed system for collecting potentially infectious samples. The DPP® HIV 1/2 Assay is one of only two FDA approved, CLIA-waived oral fluid HIV 1/2 rapid tests available in the U.S.

"Accurate diagnostic testing is an important tool in the battle against HIV/AIDS," stated John Sperzel, CEO of Chembio. "Our DPP® HIV 1/2 Assay combines excellent sensitivity and specificity, simple and safe oral fluid sample collection, and exceptional ease of use. We believe this combination will lead to more testing, which will result in increased detection, earlier treatment and lower exposure rates. We recently signed agreements with several major U.S. distributors for the DPP® HIV 1/2 and HIV 1/2 STAT-PAK® Assays and, with receipt of this latest waiver, we will expand our U.S. sales and marketing effort as planned."

The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to establish standards for all laboratory testing and amended it in 2008 to establish more stringent guidelines for in-vitro diagnostics. CLIA standards require that only accurate and easy-to-use tests are performed in the physician's office. The FDA determines whether a device is CLIA-waived based on extensive evaluations conducted in a CLIA-waived environment by intended users such as physicians, nurses and medical assistants.

Chembio's DPP® HIV 1/2 and HIV 1/2 STAT-PAK® Assays are both manufactured in the U.S. by Chembio.