Tuesday, April 25, 2023

PRESS RELEASE: ReadyGo and Gemina Laboratories to Develop a Rapid Mycobacterium Tuberculosis Diagnostic Test

ReadyGo Diagnostics Ltd. (ReadyGo), a specialist in isothermal molecular diagnostics, today announced that it has entered into an assay development agreement with Gemina Laboratories Ltd. (Gemina), a Canadian company that specialises in fast, affordable and accurate diagnostic tests.

ReadyGo will develop, optimise and validate an assay for the detection of MTB for Gemina to run on ReadyGo’s off-grid isothermal diagnostic platform, Geo. The Geo platform provides rapid results in any location in under 30 minutes and is expected to play a crucial role in the diagnosis of MTB within near patient settings which would greatly improve patient management and outcome.

MTB is a highly infectious airborne disease. There were over 10 million MTB infections globally in 2021 resulting in 1.6 million deaths. In addition, it was estimated that 4 million infections (2 in every 5 cases) remain undiagnosed and patients do not access treatment which impairs the ability to control the disease. Diagnosis in low- to middle- income countries, where the disease is most prevalent, generally involves smear microscopy from sputum samples. However, there are significant limitations to these tests, especially in remote settings and in diagnosing certain patient demographics such as children and the elderly who have difficulties producing sputum.

The diagnosis of MTB is therefore a serious and challenging healthcare issue. The World Health Organisation (WHO) has recommended the use of molecular diagnostic tests which can accommodate the use of alternative sample types such as saliva which would make testing more accessible. ReadyGo’s partnership with Gemina aims to address these recommendations and provide a test that can replace smear microscopy with a simple saliva sample which would provide a sample to answer result anywhere within 30 minutes.

Brian Firth, CEO of Gemina, commented:

"I'm excited about our partnership with ReadyGo Diagnostics. Our goal at Gemina Labs is to create better diagnostic tests for respiratory diseases. We focus on tests that are effective at the front line of patient care whether that be in the field, the home or the primary clinic. For this reason we've been impressed by ReadyGo's platform, Geo and what it could mean for the diagnosis and treatment of tuberculosis. I'm really confident that by teaming up with ReadyGo, we'll be able to create a fast and accurate TB detection solution that can make a real difference in improving patient outcomes all around the world."

Ben Cobb, CEO of ReadyGo Diagnostics, added:

"I'm really excited about our partnership with Gemina to create a simple platform for diagnosing tuberculosis. Having worked in this field for a long time, I know that a low-cost triage tool that can replace smear microscopy is desperately needed, especially in places with limited resources. We are proud of the progress made so far, and we're committed to becoming the go-to development partner for companies looking to create simple, cost-effective molecular diagnostics for different settings." 

ReadyGo Diagnostics is a rapidly growing diagnostics company that designs, develops and commercialises novel sample collection devices and diagnostic platforms. Our proprietary technology molecular diagnostic platform, Geo, permits low cost decentralised testing in under 30 minutes. Snap™ transforms sample preparation by elegantly combining sample collection with sample processing into a single, user-friendly disposable to provide optimal and reproducible results using molecular, biochemical and lateral flow tests. Snapshot™ combines this sample collection and processing architecture with an integrated molecular test to provide an all in one solution for diagnostic testing.

About Gemina Laboratories Ltd.

Gemina Laboratories Ltd. is a biosensor and diagnostic company with a transformative, patented, proprietary chemistry that powers next-generation testing platforms for a wide range of pathogens that affect human health and wellness. Our technology drives testing platforms that are fast, affordable and accurate, and easily self-administered. Our development pipeline includes platforms for the rapid testing of COVID-19, influenza and other viruses.

Saturday, April 15, 2023

PRESS RELEASE: Bruker Introduces New Mycobacteria and Fungi IVD Solutions for MALDI Biotyper®, and a Novel LiquidArray® Gastrointestinal Syndromic Panel

At the 33rd European Congress of Clinical Microbiology & Infectious Diseases (www.eccmid.org), Bruker Corporation announced its latest innovations for user-friendly, best-in-class diagnostic solutions for routine clinical microbiology and infection diagnostics laboratories.

1. Bruker introduces fast next-generation MALDI Biotyper® IVD Software

Microbial identification faster than ever: The MBT Compass HT IVD software provides a high sample throughput for microbial identification with time-to-result of ~5 minutes for 96 sample spots. Because of a fast sample target exchange, the MBT system can now analyze up to 600 samples per hour, while covering over 4,600 species in the reference library.

Microbial identification with optimal performance: The new IDealTune™, part of the MBT Compass HT IVD software, provides fully automated tuning of MALDI-TOF parameters within a sample run, delivering consistent data quality without user intervention. This seamless and effortless approach further increases performance, reproducibility, and up-time of the system.

2. Optimizing sample preparation for mycobacteria

As mycobacteria are challenging species in microbiology, an optimized sample preparation protocol is essential for robust results. The new MBT Mycobacteria IVD Kit offers a user-friendly, dedicated sample preparation method for mycobacteria cultivated in liquid as well as on solid media. The inactivation method for safe sample handling does not require boiling, but convenient incubation of the mycobacteria with an inactivation reagent at room temperature.

Dr. Arthur Pranada, Head of the Microbiology Division at MVZ Dr. Eberhard & Partner in Dortmund, stated: “During the last years the number of clinical samples with nontuberculous mycobacteria has increased, and reliable identification is important for an assessment of the clinical significance. The MBT Mycobacteria IVD Kit further simplifies the workflow for identification of nontuberculous mycobacteria by MALDI-TOF MS and reduces hands-on time. During the evaluation in our laboratory more than 96% of mycobacteria from solid and liquid media could be identified at a high-confidence level.”

Identifying challenging filamentous fungi

Identifying molds and multicellular fungi remains one of the most complex aspects of microbiology, because of varying culture conditions and colony morphology. The new MBT HT Filamentous Fungi IVD Module comes with an easy, yet powerful Mycelium Transfer (MyT) sample preparation procedure which together with a comprehensive reference library offers high identification success rates.

3. New LiquidArray® Gastrointestinal PCR Assay for Broad Syndromic Testing

Rapid culture-free pathogen identification: Bruker’s LiquidArray® technology offers rapid, multiplexed PCR pathogen detection for ease of implementation. Launched on the high-precision FluoroCycler® XT thermocycler, LiquidArray® combines innovative probe and thermocycling technologies with results-at-a-glance visualization for the simultaneous analysis of multiple targets from a single sample. The integrated FluoroSoftware® XT-IVD generates easy-to-interpret results, accelerating clinical decisions. The new LiquidArray® Gastrointestinal is a syndromic panel that enables the simultaneous detection of up to 26 pathogens causing gastroenteritis. LiquidArray® Gastrointestinal is validated on the GenoXtract® fleXT which streamlines extraction and PCR. This provides high-throughput clinical laboratories with a fully integrated workflow from sample to result.

Dr. Wolfgang Pusch, President of the Bruker Microbiology & Infection Diagnostics division, commented: “With the introduction of our new IVD workflows, kits, software and reference libraries for mycobacteria and fungi, we further expand the applications of our established MALDI Biotyper® platform. This creates additional value for all current and future customers. The new LiquidArray® Gastrointestinal is a next-generation syndromic panel with amazing pathogen coverage. It is ideal for laboratories which are interested in a broad screening approach to detect most pathogens in one run.”

Sunday, April 02, 2023

PRESS RELESE: Ad Astra Diagnostics Files FDA 510(k) Application for Rapid, Point-of-Care Analyzer to Detect Severe Infection, Including Sepsis

Ad Astra Diagnostics said Thursday it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the QScout RLD rapid-result hematology system to report white blood cell count, neutrophil-to-lymphocyte ratio, and counts of six white blood cell types in fingerstick or venous blood.

The QScout hematology platform is a rapid testing system that would operate at the point of care to provide measurements indicative of disease and infection. Such measurements include a ratio of two white blood cell types (neutrophil-to-lymphocyte ratio) and count of immature granulocytes.

Whole blood is added to a QScout RLD (rapid leukocyte differential) test, which contains a dried reagent that stains cells. When the test is inserted in the QScout Lab analyzer, an optical system takes images and an algorithm identifies cells in real time. Results are displayed in about two minutes.

The technology was funded in part by a federal contract with the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA).

Specifically, the funding was awarded by the BARDA Division of Research, Innovation, and Ventures for the earlier detection of severe infection, including sepsis in prehospital settings.

Specific levels of immature infection-fighting granulocytes can be one of the earliest markers for sepsis, the body's extreme response to infection.

The firm is seeking clearance of the system “for use at point of care where faster results can improve health outcomes and in the lab where it can improve efficiency,” Joy Parr Drach, AAD's president and CEO, said in a statement. “Meanwhile, we will continue discussions with partners who can help reach those healthcare settings."