Novodiag® CarbaR+ Test Allows Rapid Molecular Testing for Superbacteria and Associated Drug Resistance

Mobidiag Ltd., a commercial stage molecular diagnostics company addressing the spread of antimicrobial resistance, announced the CE-IVD marking of Novodiag® CarbaR+. Novodiag® CarbaR+ is a single molecular test allowing fully automated detection of Carbapenemase-Producing Enterobacteriaceae (CPE), and associated resistance markers. CPE are bacteria that are resistant to carbapenem class of antibiotics. In addition, Novodiag® CarbaR+ identifies a plasmid-mediated resistance to colistin. Colistin is considered the drug of last resort for many infections.

Novodiag® CarbaR+ combines multiplex qPCR and microarray testing in a single product allowing cost-effective and fast analysis of the most common CPE and colistin resistance markers. These bacteria may cause multiple antibiotics to perform inefficiently, which in turn can lead to serious infections, particularly in healthcare settings. The test is designed to run on-demand using the automated Novodiag® system, producing results in 80 minutes with less than five minutes hands-on time by an operator.

With two multiplex tests already available for screening antibiotic resistance (Amplidiag® CarbaR+VRE and Amplidiag® CarbaR+MCR), the new on demand Novodiag® CarbaR+ test will enable rapid patient screening for multidrug resistant organisms, helping to prevent their spread in a hospital environment, and enabling physicians to guide patient treatment accordingly.

Tuomas Tenkanen, CEO of Mobidiag, said, “Antimicrobial resistance is one of the most significant challenges to global health. Mobidiag is contributing to the fight against “super bacteria” by developing innovative diagnostic tools. Novodiag® CarbaR+ is our third test on the Novodiag® system and strengthens our offering in the fight against antibiotic resistance. Together with our Amplidiag® and Novodiag® tests, we offer comprehensive diagnostic solutions to a wide range of infectious diseases in both centralised and decentralised laboratories regardless of their size and patient volumes”.

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Artificial Intelligence Detects the Presence of Viruses

Many biosensing applications rely on characterization of specific analytes such as proteins, viruses, bacteria, among many other targets, which can be accomplished by using micro- or nano-scale particles. In such biosensors, these particles are coated with a surface chemistry that makes them stick to the target analyte forming clusters in response. The higher the target analyte concentration is, the larger the number of clusters gets. Therefore, monitoring and characterizing these particle clusters can tell us if the target analyte is present in a sample and in what concentration. Current methods to perform such an analysis are limited in that they are either capable of only a coarse readout or rely on expensive and bulky microscopes, which limit their applicability to address different biosensing needs, especially in resource limited environments.

To overcome the shortcomings of the existing solutions, UCLA researchers have developed a rapid and automated biosensing method based on holography coupled with deep learning – currently, one of the most promising and successfully used methods in artificial intelligence, AI. In this system, all the particle clusters and individual micro-particles in a sample are first imaged in 3D as holograms, all at the same time, and over a very large sample area of more than 20 mm2, more than ten-fold larger than the imaging area of a standard optical microscope. Next, a trained deep neural network processes these holograms and rapidly reconstructs them into images of clusters similar to those that could be obtained with a standard scanning microscope, but doing this much faster and for a significantly larger sample volume. During this process, all the particle clusters at the micro-scale (revealing the presence of the target analyte) are automatically counted with a sensitivity similar to a laboratory-grade microscope.

As a proof of concept, UCLA researchers successfully demonstrated the application of this deep learning-based biosensing approach to detect herpes simplex virus (HSV) and achieved a detection limit of ~ 5 viruses per micro-liter, providing a clinically relevant level of sensitivity for HSV detection. HSV is one of the most widespread viral infections that is estimated to have affected more than 50% of the adults in the US.

This work was published as a cover article in ACS Photonics, a journal of the American Chemical Society. The research was led by Dr. Aydogan Ozcan, an associate director of the California NanoSystems Institute (CNSI) and the Chancellor’s Professor of electrical and computer engineering at the UCLA Henry Samueli School of Engineering and Applied Science, along with Yichen Wu, a graduate student, and Aniruddha Ray, a postdoctoral scholar, at the UCLA electrical and computer engineering department.

“Our work demonstrates an automated, inexpensive platform for rapid read-out and quantification of a wide variety of particle clustering-based biosensors. This unique capability enabled by deep learning will help democratize biosensing instrumentation, making them suitable for wide-scale use even in developing countries,” said Ozcan.

Other members of the research team were Alborz Feizi, Xin Tong, Eva Chen and Yi Luo, members of the Ozcan Research Lab at UCLA, as well as Dr. Qingshan Wei, an assistant professor at the department of chemical and biomolecular engineering at the North Carolina State University.

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Akonni Biosystems Submits Multiplex Diagnostics System to FDA

Akonni Biosystems has submitted a molecular diagnostics system to the US Food and Drug Administration for 510(k) clearance. The system can perform multiplex testing using on-slide PCR and microarray technologies.

The system, called TruDiagnosis, consists of the TruDx imager, TruArray consumable test kit, and TruSpot software. The firm did not disclose whether a specific diagnostic assay was submitted along with the TruDiagnosis system.

The submission marks "a significant milestone" for the company, CEO and Founder Charles Daitch said in a statement, representing a critical next step in realizing Akonni's mission "to develop, manufacture, and sell molecular diagnostic tools for rapid, affordable, and accurate diagnoses that have the potential to dramatically improve the health status and cost of healthcare for millions of people worldwide."

The firm will now continue transitioning from a research and development-oriented firm to a fully integrated commercial molecular diagnostics organization, Daitch said, and it anticipates achieving its first FDA clearance and a commercial launch in 2019.

Akonni said that commercial products in the its near-term pipeline include rapid sample preparation technologies for nucleic acid extraction, as well as multiplex panel assays for pharmacogenomics, chronic diseases, and infectious diseases such as multidrug-resistant tuberculosis (MDR-TB), extensively drug-resistant tuberculosis (XDR-TB), upper respiratory infections, viral encephalitis, and hospital-acquired infections such as methicillin-resistant Staphylococcus aureus.

Akonni has been developing a multidrug-resistant tuberculosis (MDR-TB) assay since 2010, and has collaborated in the past with the New York State Department of Health's Wadsworth Center on diagnostic viral arrays, including ones for meningitis/encephalitis and influenza.

The Frederick, Maryland-based company raised $4 million in bridge financing in 2017. It has also won a Phase I Small Business Innovation Research grant from the National Institutes of Health to develop molecular diagnostic tests for lower respiratory diseases in children, NIH funds to finalize development of a rapid, point-of-care tuberculosis assay, as well as a larger SBIR award to support development and commercialization of its TB testing technology.

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ERADA Launches First Diagnostic Saliva Test for Malaria

ERADA Technology Alliance Ltd (ERADA), pioneers of innovative, rapid diagnostic solutions for early detection of infectious diseases, have announced the imminent launch of a world first diagnostic saliva test for malaria.

The saliva-based diagnostic tool, to be marketed by ERADA as a Saliva-based Malaria Asymptomatic and Asexual Rapid Test (SMAART) for subclinical infection, is set to transform malaria detection worldwide in the fight against one of the globe’s most deadly diseases. Malaria, globally kills an estimated 435,000 each year, mostly children under the age of five, mainly in Sub-Saharan Africa. [1]

The SMAART detection tool is the invention of leading, U.S based, researchers in the field of malaria diagnostics whose study is published on January 2 in the international journal, Science Translational Medicine.

ERADA’s innovative solution is easy- to-use, as it includes a simple device for standardized collection of saliva that can be implemented in the community by health care professionals, teachers and parents; contrasting with invasive blood tests, which must be administered by trained clinicians. Other drawbacks to blood tests include cultural ‘blood taboos’ existing in many countries whilst, furthermore, skin-prick tests are often stressful for children and parents.

Existing tests using blood may be invariably less reliable because subclinical infections with malaria-carrying parasites can be missed, leading some patients to come down with the disease, without knowing they have already been infected. ERADA’s SMAART-1, easy-to-use saliva test, leads to early detection, treatment and prevention of the disease as well as reducing further transmission of malaria.

ERADA’s SMAART saliva test detects a unique biomarker from female parasites circulating in an infected human who is asymptomatic, but is carrying the parasite and likely to come down with malaria within a week. Early, subclinical detection of malaria is crucial to malaria eradication because individuals who carry the parasite without exhibiting symptoms, known as carriers, are the reservoir that leads to infection of mosquitoes and transmission of the disease. Detecting the presence of the parasite before symptoms appear can save lives because malaria visible disease only erupts a couple of days after the mosquito bite.

The SMAART detection tool works by detecting a novel biomarker for Plasmodium falciparum parasites. In some areas of the world, the parasites have acquired a mutation and are therefore no longer detected by current blood-based tests. But ERADA’s saliva test detects an essential protein the parasite needs for survival, which should avoid the problem of influence from the mutation and keep the test effective long-term.

“As someone who has suffered from malaria, I know first-hand that if the parasite had been detected early, I could have been treated and cured before the symptoms of the disease made me unwell,” Dr Benji Pretorius, ERADA’s founder and Managing Director says.”

Dr Pretorius continues, “As a practicing clinician myself and following my personal experience of this debilitating disease, I was spurred on to work with my colleague Dr Richard Schmidt in our small community, Musina, in South Africa, together with a global team of scientists.” Dr Pretorius continues, “Our vision is to bring to market ERADA’s SMAART diagnostic tool as quickly as possible in the belief that it will go on to save literally millions of lives in the future.”

The World Health Organization’s recently published World Malaria Report 2018 reinforces the message that the world is currently behind 2020 milestones of the WHO Global Technical Strategy for Malaria 2016–2030. [1] Reduction in malaria cases has stalled and of particular concern is the report’s finding that, in 2017, there were an estimated 3.5 million more cases of malaria in the 10 highest burden African countries. [1,3]

“The introduction of SMAART is going to play a major part in achieving effective diagnostic testing and surveillance; as well as prevention and treatment of this disease, and therefore will be a major catalyst in meeting the WHO’s 2030 target to reduce malaria incidence and mortality by 90% ,” Dr Pretorius says. [2]

References

1. World malaria report. Geneva: World Health Organization; 2018: Available at https://www.who.int/malaria/publications/world-malaria-report-2018/en/
2. Global Technical Strategy for Malaria, 2016-2030. Geneva: World Health Organization; 2015: Available at https://www.who.int/malaria/publications/atoz/9789241564991/en/
3. https://www.who.int/news-room/detail/19-11-2018-who-and-partners-launch-new-country-led-response-to-put-stalled-malaria-control-efforts-back-on-track

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