Rapid, Portable Malaria Diagnostic Tool Developed

Researchers have developed a new portable diagnostic instrument that can screen for all malaria strains within minutes.

The portable optical diagnostics system (PODS) prototype detects a byproduct generated by all species of the malaria parasite.


"With PODS, we can do rapid, broad population screening for malaria in low-resource environments," said Andrea Armani from the University of Southern California (USC) in the US.

"When combined with currently available therapeutics, this could represent a tipping point in the global fight against malaria," said Armani.

The PODS instrument was designed to solve the challenges limiting current systems, researchers said.

To minimise size, weight, and power requirements without sacrificing performance, every aspect was considered, they said.

The current prototype weighs fewer than 4.5kg, is 12 by 10 inches (the size of a large shoebox) and can be powered by a battery for eight hours.

In addition, PODS was designed to require minimal sample processing and handling, as well as eliminate the need for secondary chemicals with strict storage requirements.

This makes the device particularly suited to low-resource environments, researchers said.

The prototype can analyse an unprocessed, whole blood sample in 10-15 minutes.

With only 500 microlitres of blood (five to seven drops), it can achieve sensitivity levels needed for an early-stage diagnosis.

Malaria-infected mosquitoes infect human hosts with the parasite. Its primary nutrient source is hemoglobin, a component of red blood cells.

As the parasite digests hemoglobin, it creates what is known as heme as a byproduct.

"While heme is highly toxic to both the parasite and its host, the parasite has figured out a 'loophole' around this by aggregating heme into an insoluble nanocrystal known as hemozoin," said Samantha McBirney, a PhD graduate at USC.

PODS has three primary components: a laser, a detector (to detect light), and a magnet.

When a sample of blood is placed between the laser and the detector, the amount of light that makes it to the detector decreases as the blood blocks it.

If hemozoin is present, even less light shines through, researchers said.

At high concentrations even in blood, it is readily apparent if hemozoin is present because the nanocrystal is very good at blocking light, they said.

Chembio Diagnostics to Sell Rapid Tests for Zika and Other Viruses in Brazil

Chembio Diagnostics Inc. plans to sell rapid tests for Zika and other viruses in Brazil, executives said Thursday. The company developed the tests with a government agency there.

The Medford-based manufacturer of diagnostic tests for HIV, syphilis and fever illnesses said it has signed a long-term agreement with Bio-Manguinhos in Brazil to commercialize the tests for Zika, dengue and chikungunya in the country.

Bio-Manguinhos is a division of the Oswaldo Cruz Foundation, an agency that develops and produces tests, vaccines and medicine for Brazil’s national health system. It has worked with Chembio for 14 years.

Since 2016, Chembio and Bio-Manguinhos have been working on stand-alone tests for Zika, dengue and chikungunya and tests where more than one illness can be detected. The products have undergone clinical trials and some have won governmental approvals in Brazil, the United States and Europe.

Separately in November, Chembio announced that it had signed a contract valued at up to $4.9 million with UNICEF to provide the Zika test and a companion results reader for use primarily in Africa.

Since 2015 there have been Zika outbreaks in more than 80 countries, including in the United States. The virus takes its name from the Ugandan forest where it was first identified in 1947.

Zika causes the birth defect microcephaly, in which infants have smaller-than-normal heads.

“Despite improved prevention measures to combat the viruses, the risk of incipient epidemic remains in many parts of Brazil,” Chembio CEO John J. Sperzel said Thursday. The company’s tests “can become important tools to discriminate among the viruses and identify co-infected patients, as we battle these debilitating and often life-threatening viruses,” he said.

New Early-Warning Device To Detect Infection In Dialysis Patients Completes Successful Clinical Pilot In Manchester

An innovative solution designed to identify infection in dialysis patients has completed a successful pilot clinical investigation following a funding award from Health Innovation Manchester.

Manchester-based medical device company Microbiosensor, secured £50,000 from the Energise Innovation Fund in 2016 to pilot their PD Safe device in Manchester.

The PD Safe is aimed at those on peritoneal dialysis therapy (PD) and acts as an early warning system for peritonitis, an infection that can prove fatal if left untreated.

PD is the lowest cost and least lifestyle compromising form of renal dialysis available in the UK, however less than 10 per cent of patients on renal replacement therapy are on PD, with an average therapy duration of only five years.

Recurrent infections are a major cause of technique failure of PD and current best practice relies on patient’s self-reporting possible symptoms of infection — abdominal pain, fever and visually checking a clear plastic waste bag for signs of cloudiness in their PD waste.

However, as the symptoms are not specific and not detectable until an infection has become well-established, patients can find making a judgement stressful and difficult – leading to a delay in time to diagnosis and treatment.

The PD Safe aims to overcome this issue by plugging into existing PD waste fluid tubing and flagging an emerging infection at a pre-symptomatic stage via a simple colour change in a readout window.

The device uses a small dialysis waste sample from the patient to fill a series of reaction chambers containing chemicals which can detect bacteria and provide a rapid, clear colour change to alert the user to the infection.

Following the funding award, Microbiosensor have completed a successful pilot clinical investigation of the PD Safe device at the Manchester Royal Infirmary renal centre, working with Consultant Nephrologist Dr Anand Vardhan at the PD clinic.

The device successfully acted as an early warning system for infection, detecting bacteria within samples from patients, including one who was admitted to A&E within a few days as they went on to develop peritonitis.

Ben Bridgewater, CEO of Health Innovation Manchester, said: “The PD-Safe device is an excellent example of the solutions Health Innovation Manchester aims to support in their journey to market.

“The successful pilot clinical investigation in Greater Manchester marks a great leap forward in the project which has the potential to meet the needs of local people and patients.

“It is vital that products like the PD-Safe are given support in order to transform health and social care and Health Innovation Manchester is uniquely placed to champion these innovations and connect researches, academics, business and the NHS in Greater Manchester.”

Gordon Barker, CEO of Microbiosensor, said: “The Energise funding from Health Innovation Manchester helped Microbiosensor improve its understanding of clinical trial management at a major NHS Trust and strengthen the design of a subsequent larger study at Manchester Royal Infirmary.

“It has made a significant contribution to Microbiosensor efforts to bring its novel medical device technology to market.”

Microbiosensor has also secured a £1.4million Series-A co-investment from the Northern Powerhouse Investment Fund (managed by Maven Capital Partners) and the Greater Manchester and Cheshire Fund (managed by Catapult Ventures) to support the company through it final product development stages.

Karius Announces Launch of Quantitative, Broad-Based Infectious Disease Diagnostic Test Using Microbial Cell-Free DNA

Karius, the leading U.S. infectious disease genomics company, announced today that the new version of its proprietary Karius Test can now quantify the abundance of pathogens detected. The test uses next-generation sequencing of microbial cell-free DNA (cfDNA) to identify over 1,000 pathogens from a single blood sample. Results are typically delivered the next day*. Karius is announcing its latest advances at the first annual HLTH “The Future of Healthcare” conference and is making the test immediately orderable to physicians nationwide**.

The Karius Test uses next-generation sequencing (NGS) to enable broad and rapid detection of bacteria, DNA viruses, fungi and protozoa in one broad-based test for infectious diseases. With a standard blood draw, the test identifies cell-free DNA (cfDNA) fragments left by microbes in a patient’s bloodstream, even when living organisms are no longer detectable in the blood or when patients have been pre-treated with antibiotics. Karius reports the presence and abundance of microbial cfDNA to physicians when statistically significant levels are detected above background.

“The new quantitative capabilities we added to our test give clinicians even greater insight – now not only delivering answers on which pathogens are present, but also the extent of the infection, enabling doctors to make more informed treatment decisions,” said Karius CEO Mickey Kertesz, Ph.D. “We are committed to delivering the highest quality service for clinicians to more rapidly diagnose infectious diseases, helping save lives in the most challenging diagnostic dilemmas including immunocompromised patients, complicated pneumonia, culture-negative bloodstream infections and invasive fungal infections.”

The Karius Test has been commercially available for over a year and has helped clinicians accurately detect pathogens in diagnostically challenging situations, including sepsis, endocarditis, fever of unknown origin, and in patients who have received antibiotic pre-treatment. It has also been useful for hematologist-oncologists who actively monitor immunocompromised patients susceptible to a broad range of pathogens, including stem-cell transplant recipients.

Dr. Kertesz will participate in the “Next Gen Genomics” panel discussion at HLTH on May 8, moderated by Jon Shieber, senior editor at TechCrunch. The panelists will discuss the immense potential of genomics and areas within the field that need further development.

HLTH is a leading event for innovation in healthcare that is creating a dialogue focused on disruptive innovation across the healthcare ecosystem. The HLTH agenda for 2018 will feature over 300 speakers from today’s most successful and innovative companies and thought leaders in the industry.

*From receipt for about 80% of samples received by 8:30 a.m. Monday to Friday.
**Karius is not yet a New York State-approved clinical laboratory, thus it cannot accept orders for patients in that state without an exemption.

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert Xpress Strep A

Cepheid announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and waiver under the Clinical Laboratory Improvement Amendments (CLIA) for the Xpert® Xpress Strep A test. The test can be performed in near-patient settings by untrained users, to provide rapid and accurate molecular detection of Streptococcus pyogenes (i.e., Group A Strep) in as little as18 minutes.1

"The rapid results provided by Xpert Xpress Strep A test can facilitate antimicrobial stewardship in the outpatient setting consistent with renewed healthcare provider focus on the reduction of unnecessary antibiotic use in ambulatory care settings. It also leverages the versatility of our platform to improve patient care," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.

Xpert Xpress Strep A utilizes automated real-time polymerase chain reaction -PCR- to detect Streptococcus pyogenes DNA. The on board reagents deliver high-performance specifications with no requirements for culture confirmation of negative results unless clinical symptoms persist or there is an outbreak of acute rheumatic fever.

Mologic Signs Agreements with Two Medical Companies for Distribution of Point-of-Care Test

Mologic (developer of personalised diagnostics) has signed agreements with two medical companies, Medisur and Peripal, for the distribution of a rapid point-of-care (POC) test for the detection of infection in patients on peritoneal dialysis (PD) — PERiPLEX.

Both medical companies involved in this agreement specialise in the development and distribution of products that enable patient self-management. Under the terms of the agreement, they will supply PERiPLEX as part of a product portfolio in key European markets including France, Germany, Italy, The Netherlands, Austria and Switzerland.

PD is becoming widely accepted as a preferred method for managing end-stage renal disease as it offers greater patient mobility and independence compared to other dialysis options, as well as being gentler to residual kidney function in early-stage disease. Recurring infection, or peritonitis, is a major issue for PD patients especially as there is no effective diagnostic test that can provide early indication of infection. Using current methods, diagnosis of infection can take more than 24 hours, which risks damage to the peritoneal membrane, or the formation of scar tissue, preventing long-term use of PD.

The rapid POC test detects two critical biomarkers of infection in PD waste fluid using a lateral flow immunoassay system and provides a visual result within 10 minutes. A positive result indicates to patients that there is an infection and therefore can be used to initiate contact with their healthcare provider for antibiotic therapy.

Earlier identification of infection can enable pre-emptive antibiotic therapy, resulting in improved management of infection and prevention of infection-related damage to the peritoneal membrane.

“Establishing a global distribution network is integral to Mologic’s product commercialisation strategy,” commented Mark Davis, co-founder and CEO at Mologic. “With the appointment of distributors across Europe we will ensure PERiPLEX is available to more patients, giving them greater choice and the confidence to monitor their dialysis at home. Medisur and Peripal share our mission to improve the lives of patients by bringing diagnostics and treatment closer to home, and with highly complementary product portfolios, we look forward to working together.”

The PERiPLEX technology was developed following a collaborative project with Cardiff University Medical School, funded by the National Institute of Health Research (NIHR).

New Technique Allows Quick Detection of Virus in Bodily Fluids

Broad Institute of MIT and Harvard researchers have created a new tool that better prepares the CRISPR-based diagnostic tool, SHERLOCK, for rapid response to viral outbreaks.

The updates allow clinicians to quickly and cheaply diagnose patient samples and track epidemic spread directly in bodily fluids, eliminating the need for excessive lab equipment and allow more rapid efforts to be conducted in the field. SHERLOCK has also been updated to better distinguish between related viral species, allowing it to identify mutations.

“Rapid and sensitive tools are critical for diagnosing, surveilling, and characterizing an infection,” Pardis Sabeti, an institute member at Broad, a professor at Harvard University, and Howard Hughes Medical Investigator, as well as senior study author, said. “We’ve taken the SHERLOCK technology and optimized it in the context of these very applied biological scenarios.”

Sabeti’s team hopes to build on this further and seeks to test SHERLOCK with Nigerian collaborators, as a means of addressing their recent Lassa fever outbreak. The recent effort was led by Harvard graduate student Catherine Freije and postdoctoral scientist Cameron Myhrvold, who developed a simpler method for an enzyme involved in the platform to detect its target directly in bodily fluid samples.

“In places like South America, many similar viruses co-circulate, and having a diagnostic that can quickly tell the difference is critical,” Freije said. “With this new assay, a patient can give a single blood or urine sample, it can be analyzed in just a few reactions to determine which virus it contains, and then that patient can get started on the right treatment.”

Already, the team has shown SHERLOCK’s sensitivity to mutations that occur in something as small as a single nucleotide and designed assays that could identify Zika virus mutations associated with microcephaly. Broad hopes to make the SHERLOCK diagnostic platform easily accessible in the developing world.