Friday, September 29, 2017

Chembio Receives FDA Emergency Use Authorization for the First Rapid Zika IgM Test

Chembio Diagnostics, Inc., a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its DPP® Zika System.

The DPP® Zika System, which provides results in 15-20 minutes from only 10┬ÁL of blood, is the first rapid Zika test to receive an FDA EUA for use in high and moderate complexity CLIA certified laboratories.  The DPP® Zika System includes the DPP® Zika IgM Assay and DPP® Micro Reader, which is portable, hand-held, easy to use, and can reduce the risk of human error during test interpretation.

The test is authorized for the presumptive detection of Zika virus IgM antibodies in fingerstick whole blood, EDTA venous whole blood, EDTA plasma (each collected alongside a patient-matched serum specimen) or serum (plain or separation gel) specimens collected from individuals meeting CDC Zika virus clinical and/or epidemiological criteria, from 8 days of on-set and up to 12 weeks.

The DPP® Zika System has been authorized by FDA under an EUA for use in authorized laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendment (CLIA), to perform high or moderate complexity tests, or by similarly qualified non-U.S. laboratories.  The DPP® Zika System utilizes the patented technology platform used in the Company's FDA approved and CLIA waived DPP® HIV 1/2 Assay.  The DPP® Zika System has not been FDA cleared or approved and has been authorized only for the diagnosis of Zika virus infection and not for any other viruses or pathogens. The DPP® Zika System is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Sharon Klugewicz, acting Chief Executive Officer, commented, “We are delighted to receive FDA Emergency Use Authorization for our DPP® Zika System and we appreciate the close interaction with the FDA throughout the EUA process. We believe the deployment of a rapid test for the presumptive detection of human IgM antibodies to Zika virus will be a critical tool in dealing with the ongoing spread of Zika virus, and we plan to make the DPP® Zika System immediately available in the U.S., Puerto Rico, and the U.S. Virgin Islands.”

This project has been funded in part with federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).  Chembio has been awarded a contract for $5.9 million to develop the product and obtain FDA EUA authorization and FDA 510(k) clearance with the potential of $13.2 million in total funding from BARDA if all options are exercised, to advance clinical development of its DPP® Zika System and its DPP® Zika / Dengue / Chikungunya System.

Breakthrough Rapid Screening for Ebola

A new, faster and safer way of diagnosing the Ebola virus has been developed by an academic from Northumbria University, Newcastle.

Research led and carried out by Dr Sterghios Moschos at Northumbria means that patients with Ebola-like symptoms can be identified and treated much sooner and at the point of care, helping to reduce the spread of the disease and risks to others.

During the Ebola outbreak in Africa in 2014, patients tested for the disease had to provide a blood sample fortesting in a specialist lab by highly trained staff., There are only a few of these facilities in the world, including Public Health England's Lab in Porton Down in the UK, with each diagnosis of the Ebola virus genome taking between5-8 hours to confirm.

Thanks to the efforts of Dr Moschos' research team, working with a manufacturer of innovative diagnostic solutions, a new point of care diagnostic platform – EbolaCheck—has been developed, which can be deployed to the scene of an outbreak. The test can now be carried out on an amount of blood that is 700 times smaller than previously needed—literally a drop obtained by 'pin pricking' a finger—and it now takes less than 70 minutes to complete. As a result, the test is much safer to administer, requires minimal training and reduces the cost of diagnosis significantly. Crucially, its performance is comparable to laboratory testing, meaning any patient with symptoms of Ebola can be safely and reliably diagnosed.

The research has been funded by a grant from Elrha's Research for Health in Humanitarian Crises (R2HC) Programme, and uses proprietary technology developed by BioGene Ltd. The prototype is called the 'QuRapID'.

The R2HC programme aims to improve health outcomes by strengthening the evidence base for public health interventions in humanitarian crises. In response to the Ebola outbreak in West Africa, R2HC launched an emergency Ebola Health Research Call in August 2014, aiming to fund research which would help to strengthen interventions to tackle this and future outbreaks.

BioGene Limited are based near Cambridge and provide a 'solution-based' portfolio of products, services and support—to encompass the key application areas of molecular biology to include Nucleic Acid Purification, Target Amplification and Post-Amplification Analyses.

A number of organisations have been involved in the research, including BG Research Ltd, the University of Westminster, Public Health England, Flurogenics Ltd, Diagnostic Systems Division and Virology Division of the United States Army Medical Research Institute of Infectious Diseases and Kwame Nkrumah University of Science and Technology in Ghana.

The technology could also be used in the diagnosis of other high-risk viruses such as the Zika, MERS, SARS, flu, and dengue viruses, but also bacterial and parasite infections, including meningitis and malaria. This is because it detects and measures genes and genomes and so has broader applications in medicine.

Dr Sterghios A. Moschos, Associate Professor of Cellular and Molecular Sciences at Northumbria University, led the research. He said: "During the Ebola outbreak, between 2013 & 2016, over 28,500 individuals contracted the disease with a mortality rate of 39.5%. These people often had to walk for hours to reach overflowing treatment centres, or wait for days for samples to be processed. Some were put at risk having to wait next to probable Ebola virus cases for an 'all clear'- usually because the symptoms of other diseases, like malaria, made them fear they had the Ebola virus.

"The development of this pioneering technology could essentially save lives and reduce the spread of the disease, which is crucial in a humanitarian crisis. Due to there being no further cases since it was developed, to date, it has not been possible to take the test out of the lab, into the field, where the patient needs it. However, it can be deployed anywhere—the frontline in Africa where this disease is found, as well as international airports and ports—to help stop the disease from spreading and to prevent disruption of international trade and travel. It could also be used in the diagnosis of other infectious diseases, as well as bringing genetic testing to the shop front, for example in a pharmacy or a GP surgery."

Nelson Nazareth, Managing Director of BioGene Ltd, which developed and manufactured the equipment, said: "We are delighted to have worked with Dr Moschos and his team on the project. BioGene is at the forefront of innovative, UltraRapid Molecular Biology solutions for rapid detection of nucleic acids and this research has led to a very exciting platform technology, and one that we are looking to develop further."

Dr Moschos' research findings are published in The Royal Society of Chemistry's Chemical Science.

Reference: Kavit Shah et al. Field-deployable, Quantitative, Rapid Identification of Active Ebola Virus Infection in Unprocessed Blood., Chem. Sci. (2017).

New Paper-Based Test Rapidly Diagnoses Zika

MIT researchers have developed a paper-based test that can diagnose Zika infection within 20 minutes. Unlike existing tests, the new diagnostic does not cross-react with Dengue virus, a close relative of the Zika virus that can produce false positives on many Zika tests.

This test could offer an easy-to-use, cheap, and portable diagnostic in countries where Zika and Dengue are both prevalent and the gold-standard test that measures viral RNA in the bloodstream is not available.

“It’s important to have a single test that can differentiate between the four serotypes of Dengue and Zika, because they co-circulate. They’re spread by the same mosquito,” says Kimberly Hamad-Schifferli, an associate professor of engineering at the University of Massachusetts at Boston, a visiting scientist in MIT’s Department of Mechanical Engineering, and a co-senior author of the paper.

The researchers worked with scientists around the world to test the new device on patient samples and confirmed that it can accurately distinguish Zika virus from related viruses.

Lee Gehrke, the Hermann L.F. von Helmholtz Professor in MIT’s Institute for Medical Engineering and Science (IMES), is also a senior author of the study, which appears in the Sept. 27 issue of Science Translational Medicine. The paper’s first authors are IMES research scientist Irene Bosch and Department of Mechanical Engineering postdoc Helena de Puig.

No more false positives

One of the biggest challenges in diagnosing Zika is that many of the tests are based on antibodies that interact with a viral protein called NS1, which is found in the bloodstream of infected patients. Unfortunately, many other viruses from the same family, known as flaviviruses, have similar versions of NS1 and can produce a false positive. Flaviviruses include West Nile virus and the virus that causes yellow fever, as well as Dengue virus.

In an effort to create a more precise diagnostic, the MIT team set out to find antibodies that would interact exclusively with NS1 protein produced by the Zika virus, as well as antibodies specific to NS1 from each of the four different strains of the Dengue virus.

To achieve this, the researchers exposed mice to Zika and Dengue viruses and then screened the resulting antibodies, in pairs, against every flavivirus’ version of the NS1 protein. This allowed them to identify pairs of antibodies that react only with one version of NS1 and not any of the others.

“We knew by informatics analysis that if we looked enough, and we teased out the repertoire of the B cells of these animals, we would eventually find those antibodies,” Bosch says. “We were able to tease out the very few antibodies within the repertoire that would give you uniqueness in the detection.”

The researchers used these pairs to create five separate tests, one for each virus. They coated strips of paper with one antibody from each pair, while the second antibody was attached to gold nanoparticles. After adding the patient’s blood sample to a solution of these nanoparticles, the paper strip is dipped into the solution. If the target NS1 protein is present, it attaches to the antibodies on the paper strip as well as the nanoparticle-bound antibodies, and a colored spot appears on the strip within 20 minutes.

This approach requires five test strips per sample to test for each virus, but the researchers are now working on a version that would test for all five with one strip.

Most countries where Zika and Dengue are prevalent do not allow patient samples to be shipped out of the country, so the researchers traveled to several countries, including Mexico, Colombia, India, and Brazil, to test their devices with patient samples.

They found that their results were comparable to those obtained by polymerase chain reaction (PCR) tests, which detect viral RNA in the bloodstream. PCR tests are not widely used in areas where Zika virus is found because they require trained personnel and lab equipment that are not available everywhere.

“Since conventional methods require a great deal of time for sample collection and diagnostics, this inexpensive, paper-based, rapid diagnostic will be very useful for the diagnosis of many infectious diseases,” says Luke Lee, an associate president of the National University of Singapore and director of the Biomedical Institute for Global Health Research and Technology in Singapore.
Emerging viruses

Dengue infects hundreds of millions of people annually, mostly in tropical regions. It is usually not fatal, but in areas where there is more than one serotype circulating, it is more likely to produce a severe, potentially life-threatening illness. A diagnostic that can distinguish between all four serotypes of Dengue fever could give doctors a way to discover early on when a new serotype has entered their region.

“When we have traveled to the places where these viruses are problems, the people there unanimously say that they need more surveillance. They need to know which viruses are circulating in their environments,” Gehrke says.

The researchers believe that their approach should also enable them to quickly develop diagnostic tests for other related viruses that might emerge in the future.

“By already screening this group of antibodies that we have against all these antigens we have, like West Nile, we already know how well they react. So that’s information we could use in the future to develop additional tests that can be used to detect other emerging viruses,” Gehrke says.

They are now working on a diagnostic for the emerging Powassan virus, which is carried by the same tick that spreads Lyme disease. Powassan, found mainly in the northeastern United States and the Great Lakes region, causes a severe form of encephalitis.

The research was funded by the U.S. Public Health Service and the Science, Technology and Innovation Fund of Colombia.

Bruker Announces Acquisition of MERLIN to Add Antibiotic Resistance and Susceptibility Testing to its MALDI Biotyper® Microbial ID Platform

Bruker announced the closing of its acquisition of MERLIN Diagnostika GmbH, located near Bonn, Germany.  MERLIN has in-depth expertise in products, services and consulting in the fields of antibiotic resistance testing (ART) and antibiotic susceptibility testing (AST).  MERLIN's technology and product portfolio for human and veterinary antibiotic resistance and specialty susceptibility testing further expands Bruker´s microbiology business, which is based on rapid, broad-based microbial identification using Bruker's market-leading MALDI Biotyper (MBT) platform for proteomic fingerprinting.  Financial details were not disclosed.

The principle of the MERLIN MICRONAUT™ system for specialty susceptibility testing is the phenotypic detection of microbial growth inhibition in the presence of antibiotics.  Its microdilution procedure is a standardized, globally accepted reference method for the determination of minimal inhibitory concentrations (MICs).  Standard and special AST plates are available for in-vitro diagnostic use according to the EU directive EC/98/79 for a wide spectrum of clinically important microorganisms.  MERLIN's focus is on the detection of major resistance phenotypes, i.e. MRSA, VRE, MBL, ESBL, KPC, AMP-C, and OXA-48.  In addition, MERLIN has the ability to customize antibiograms for more than 200 antibiotics.  Due to this flexibility, the MICRONAUT system enables laboratories to adjust their testing profiles to the rapid spread of certain new resistances.  MICRONAUT software for identification and susceptibility testing includes an expert plausibility check, and has for several years already offered an interface to Bruker´s MALDI Biotyper.

MERLIN is a member of the German Diagnostic Industry Association (VDGH) and the Paul-Ehrlich-Society for Chemotherapy, and MERLIN is involved in various studies related to antibiotic resistance, e.g. the monitoring of drug resistance among clinically relevant pathogens in Germany and central Europe.  For such multicenter studies involving human and veterinary medicine, MERLIN offers the design and production of dedicated MIC study plates, as well as scientific consulting and support.  MERLIN acts as a reference laboratory for annual inter-laboratory tests by the INSTAND organization for quality assurance in microbiology.

MERLIN will continue to serve all existing collaboration and distribution partners, as well as all OEM customers and end customers after the acquisition.

Dr. Esther Pfeil, Managing Director of MERLIN Diagnostika GmbH, commented: "We are very pleased to be part of Bruker´s microbiology business now, as we have been collaborating with Bruker already for several years.  Our product and service offerings in the field of antibiotic susceptibility testing (AST) complement the MALDI Biotyper system for fast and efficient microbial identification.  With our proven expertise in the field of AST, we aim to accelerate further assay additions to the MBT-STAR™ consumables portfolio for selected, rapid antibiotic resistance and susceptibility testing on the MALDI Biotyper."

Dr. Johann-Wolfgang Wittke, Managing Director of the Medical Laboratory Bremen (Germany), said: "Our laboratory has been working with Bruker´s MALDI Biotyper for microbial identification and the MICRONAUT system from MERLIN for many years.  The MICRONAUT microdilution approach with the determination of true minimal inhibitory concentrations has leading analytical performance and reliability.  We use MERLIN's custom-tailored microtiter plates to answer different microbiological questions, or for the detection of resistance mechanisms.  This flexibility is unmatched in the market, and I am looking forward to further integration, synergies and reduction of hands-on time."

Dr. Wolfgang Pusch, Executive Vice President for Microbiology & Diagnostics at Bruker Daltonics, added: "MERLIN adds expertise and an impressive portfolio of flexible specialty products for antibiotic susceptibility testing to Bruker's clinical and applied microbiology business.  Over time, we expect that MERLIN will further expand our selected, high-value ART and AST assay portfolio for the MALDI Biotyper."

Monday, September 25, 2017

iBio and TheoremDx Collaborate to Develop Proteins for Rapid Diagnostics Testing Products

iBio, Inc., with its subsidiary, iBio CDMO LLC in Bryan/College Station, Texas, has partnered with TheoremDx, Inc., in Edina, Minnesota, to develop proteins for rapid diagnostic testing products.

The collaboration will leverage the TheoremDx point-of-care diagnostic system and the protein development and manufacturing capabilities of iBio. The goal of the collaboration is to serve the citizens of the US and the world through the rapid development and manufacturing of proprietary plant proteins for point-of-care diagnostic testing products. The initial focus is on developing rapid diagnostic tests to identify and distinguish specific neglected tropical diseases (Zika, Dengue, Chikungunya, and West Nile) from each other and to create a superior next generation HIV test. Rapid and simultaneous testing for these tropical diseases is desirable because they may present with similar symptoms but require different therapies. iBio has already delivered new proteins to TheoremDx for testing.

The iBio CDMO leadership team has worked with TheoremDx over the last six months to generate new approaches for engineering proteins to optimize TheoremDx’ proprietary diagnostic system for the identification of multiple diseases and therapeutic choices. iBio CDMO operates its large biotherapeutics manufacturing facility in the Texas A & M Biocorridor.

Dr. Bruce Batten, Chief Scientific Officer of TheoremDx, commented, “TheoremDx has leveraged the flexibility of the iBio system to screen multiple candidate proteins to optimize diagnostic capabilities in our system.”

Dr. Barry Holtz, President of iBio CDMO, stated, “Our expression system delivers candidates quickly to TheoremDx and our production system allows rapid, confident cGMP scale-up of production. This collaboration meets the demands for rapid establishment of new diagnostics.”

Both iBio and TheoremDx see the collaboration as a major strategic step in advancing early rapid infectious disease detection internationally and the crucial role it plays in treatment and prevention strategies.

Primary leadership for the collaboration includes Frank Kiesner (CEO, TheoremDx Inc.), Stephanie Griffin (EVP, TheoremDx Inc.), Dr. Bruce Batten (CSO, TheoremDx Inc.), Robert Erwin (President, iBio Inc.) and Dr. Barry Holtz (President, iBio CDMO LLC).

About TheoremDx, Inc.

TheoremDx, Inc., is an in vitro diagnostics company committed to innovating solutions that meet the global need for rapid diagnostic testing for infectious disease, antibiotic resistance, and healthcare-associated infections. The Company’s THEO™ system leverages proprietary molecular identification and susceptibility methods.  The Company’s product pipeline is focused on neglected tropical disease, HIV, bacterial ID and AST testing.

About iBio, Inc.

iBio, a leader in developing plant-based biopharmaceuticals, provides a range of product and process development, analytical, and manufacturing services at the large-scale development and manufacturing facility of its subsidiary iBio CDMO LLC in Bryan, Texas.  The facility houses laboratory and pilot-scale operations, as well as large-scale automated hydroponic systems capable of growing over four million plants as "in process inventory" and delivering over 300 kilograms of therapeutic protein pharmaceutical active ingredient per year. iBio applies its technology for the benefit of its clients and the advancement of its own product interests. The Company’s pipeline is comprised of proprietary candidates for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, based on the Company's proprietary gene expression technology, is the Company’s lead therapeutic candidate being advanced for IND development.

Biofire FilmArray will be used to complete rapid tests for meningitis at Worcestershire Royal Hospital

An innovative, rapid test for meningitis is now being used at Worcester hospital which speeds up diagnosis and saves lives.

Accurate results come in within an hour as part of a test to help head off the life-threatening infection of the membranes surrounding the brain which can develop quickly and can kill within hours.

Until now, the tests used to identify this infection took up to two days to get a result. The tests to identify encephalitis – an infection of the brain itself - took even longer to diagnose, usually up to four days.

Last week (September 18 to 24) was Meningitis Awareness Week, and was marked by the transformation of diagnosis of the infection in Worcestershire’s acute hospitals, with the use of a new piece of equipment which rapidly analyses samples and produces accurate results in just one hour.

The new technology, the Biofire FilmArray® , allows the laboratory at Worcestershire Royal Hospital to inform doctors of a positive result much faster, leading to targeted treatment and reassurance for patients and their families.

The rapid test also means negative results are identified much quicker, reducing inappropriate treatments and unnecessary hospital stays. The technology works by analysing a patient’s spinal fluid for up to 14 different bacteria and viruses.

Consultant Microbiologist, Dr Mary Ashcroft said: “Meningitis can develop very quickly and can kill within hours. Whilst treating immediately because of suspicion of meningitis is the most important aspect of managing suspected cases, having early, accurate diagnosis that allows prompt and targeted treatment is essential for improving outcomes for patients. This new test has transformed the way we diagnose these dangerous infections.”

Worcestershire Acute Hospitals NHS Trust was one of the first hospital trusts in the country to extensively trial this new technology.

The Biofire FilmArray® testing is now being carried out as a part of routine laboratory testing and is available seven days a week at Worcestershire Royal Hospital.

Microbiology Laboratory Manager at Worcestershire Royal Hospital, Peter Jackson said: “The new test looks for a specific target area of the genome of a bacteria or virus. Even in small numbers these will be detected, as the process makes multiple copies of the area to increase detection and get such quick results."

Anyone can get meningitis although some forms are more common in different age groups. Some bacterial causes of meningitis can be associated with outbreaks and although outbreaks are relatively rare in the UK, when they do occur they can develop very quickly and contact between people can spread the infection more widely.

Transasia Bio-Medicals Launches Rapid Detection Kits for Dengue and Malaria

The city-based Transasia Bio-Medicals Ltd has introduced the ErbaQik range of rapids for dengue and malaria detection. The ErbaQik kits have been proven to have superior specificity (100%) and sensitivity (>92%) for all parameters of dengue and malaria, based on extensive evaluation studies at reputed NABL labs. ErbaQik rapids have been recognized as the most reliable in India today.

These affordable test kits, will be particularly relevant in India where 1.29 lakh cases of dengue resulted in 245 deaths in 2016. The kits have been launched across India including tier II, III and IV cities and are available at most government and private hospitals as well as diagnostic centers.

Malaria and dengue diagnosis relies on clinical assessment and serological tests such as rapid diagnostic tests and ELISAs. Rapids are preferred for initial screening because of their advantages such as faster reporting of results (less than 30 minutes compared to 120 mins taken by ELISAs), ease of use, limited resource allotment and affordability.

According to clinicians, detection of the disease early on and more importantly accurate detection is the need of the hour. Test kits are often marred by the concerns of high percentage of false results. Thus, the sensitivity and specificity (avoidance of false results) become crucial parameters. It is imperative for labs and hospitals to choose the detection kits that have been assessed and approved by reference reputed labs for their sensitivity and specificity.

Transasia Bio-Medicals Ltd. is India’s leading in-vitro diagnostic company with an entire gamut of instruments and reagents/kits for detection of diseases, infections and other conditions like thyroid disorders, autoimmune disorders, HIV, hepatitis, syphilis, etc. The company is among true Indian multinationals with manufacturing facilities across six countries and products sold to more than 104 countries.

Talking about ErbaQik kits, YS Prabhakar, CEO, Transasia Bio-Medicals Ltd. said, “It has always been an endeavour at Transasia to ensure that India has access to the best diagnostic solutions in the world. We have ensured that these are affordable too. The ErbaQik test kits are truly a ‘make in India’ initiative and we are proud to introduce these kits as the most reliable and affordable solutions for rapid detection of dengue and malaria.”

India ranks third in the world having the highest cases of malaria and deaths due to the disease. While Zika virus is a growing concern for the world, dengue and malaria still rule the roost and are yet to see a marginal decrease.

In recent years, the transmission of both malaria and dengue fever has increased predominantly in both the urban and semi-urban areas. New cases as well as recurring outbreaks have been recorded from Andhra Pradesh, Delhi, Goa, Haryana, Gujarat, Karnataka, Kerala, Maharashtra, Rajasthan, Uttar Pradesh, Odisha, Pondicherry and West Bengal.

On its part the health ministry is taking all efforts to curb the spread of these diseases by creating awareness campaigns on sanitization and propagating the need for early detection. However, currently there is no commercially available vaccine for these diseases.

Dr. Suvin Shetty, HOD Laboratory Medicine, Dr. L.H. Hiranandani Hospital added, “All rapid test kits available in the market today have Gold nanoparticle that are used as conjugate in the test membrane strip. As the sample passes through the strip, the gold particle conjugate creates a coloured test and control band. However, there can be errors in interpretation since both test and controls bands can appear to be of the same colour. This increases the chances of a false result.”

The Erba Qik range of rapids for dengue and malaria use two different sizes of gold particles to generate two visually distinct coloured bands for test and control. As a general rule, the colour of the gold nanoparticle solution changes with the change in the size of the particle, ranging from red to purple black with the increasing particle size.

Using a different size of the gold nanoparticle called as ‘Black Gold’ particle gives ErbaQik rapids a unique dual colour advantage (purple black Test band and red Control band) making them the only bi-colour detection immuno-chromatographic device.

Moreover, the larger size of the Black Gold particle provides a larger surface area for the reaction, thereby enhancing the sensitivity and the specificity of the test and reducing the incidence of false results.

Thursday, September 14, 2017

Tel Aviv University Announces Collaboration With Biosynth on Pioneering Chemiluminescent Reporter Molecules

Biosynth, a global company supplying intermediate chemicals to the life science industry and Tel Aviv University (TAU) through Ramot its Business Engagement Center, announce the signing of a licensing agreement giving Biosynth the right to manufacture and sell probes invented by Prof. Doron Shabat from the TAU School of Chemistry.

Prof. Doron Shabat has developed a series of Dioxetane based novel chemiluminescence probes for research and diagnostic applications. This work was recently published in ACS central science and received much attention and follow up comments.

These probes offer unique advantages as they can work as single agents (without the need for enhancers), they have a higher efficiency and sensitivity over currently existing probes, they are especially designed to work under physiological conditions and can be used ex-vivo and in-vivo.
 Dr. Urs Spitz, President of Biosynth declared: “We develop reporter molecules for bioanalytical and diagnostics producers across the globe. As soon as I read Doron’s publication I realized how huge the invention’s potential really is - it will dramatically improve the handling and speed of bio tests.”
 Biosynth will receive a license to manufacture the probes and sell them to customers who develop and sell kits. The series of invented probes have multiple commercial applications, targeting a potential multibillion dollar market. Ramot has filed the series of probes under the trademark name AquaSpark.

"We are confident that Biosynth is the right partner with the most professional tools to rapidly bring this technology to the market. We intend to work with Biosynth to generate many agreements with multiple players in the various life science sectors in order to make AquaSpark™ the acknowledged standard Dioxetane-based novel probe for research and diagnostic applications”, said Dr. Adi Elkeles, VP BD Life Sciences, Ramot.

Prof. Shabat summarized: “We are extremely encouraged by the speed at which our initial communication and cooperation has developed and I look forward to expanding our collaboration with additional extensions of the current technology which look very promising”.

Contact Information

Media Contact – Biosynth
Mario Mehmel, Ph.D. +41.71.858 2658

Media Contact – Ramot at Tel Aviv University
Maya Kotler, +972.52.605 7144

About Tel Aviv University 

Tel Aviv University (TAU) - Israel's largest and most comprehensive institution of higher learning - is home to over 30,000 students studying in nine faculties and over 125 schools and departments across the spectrum of sciences, humanities and the arts.

Situated in Israel's cultural, financial and technological capital, TAU shares Tel Aviv's unshakable spirit of openness and innovation – and boasts a campus life as dynamic and pluralistic as the metropolis itself. Tel Aviv the city and Tel Aviv the university are one and the same – a thriving Mediterranean center of diversity and discovery.

Consistently ranked in the top 20 in the world in terms of scientific citations and among the top 100 universities internationally, Tel Aviv University is also Israel's first choice for students, and its graduates are the most sought after by Israeli companies.

About Ramot at Tel Aviv University

Ramot is the Business Engagement Center at Tel Aviv University, Israel's largest research and teaching university. Founded in 1956, Tel Aviv University is located in Israel's cultural, financial and industrial center. Rooted in both academic and corporate arenas, Ramot is uniquely positioned to cultivate the special relationships between these two compelling worlds, creating win-win connections that support fertile, ground breaking research while providing companies with discoveries that give them a crucial competitive edge. For more information, visit

About Biosynth

Biosynth is an accomplished player with a successful history in the field of biochemicals for the diagnostics, pharmaceutical and chemical industries as well as food and environmental analysis. Biosynth's own biology and chemistry labs constantly drive the further development of molecules for the sensitive detection of pathogens. In recent years Biosynth has successfully introduced innovative chromogenic, fluorogenic and luminescence-based systems into the field. The Swiss-based organization has branches in the USA, China and the EU as well as a worldwide distribution network that reaches the entire diagnostics industry. Biosynth, with its product offering of over 80’000 substances is a competent partner for industrial as well as research customers.