GenMark Diagnostics (Carlsbad, CA, USA), a member of the Roche Group (Basel, Switzerland), has rebranded its ePlex® system as the cobas eplex system. This rebranding under the globally renowned cobas name underscores Roche’s dedication to ongoing enhancement across its entire product line, encompassing everything from raw materials and manufacturing to quality control. The cobas eplex system has been redesigned with new features that enhance usability, reliability, and serviceability. Notable improvements include onboard quality control tracking and monitoring, eSignature capabilities, onboard epidemiology reports, email alerts, and customizable comments to support clinical decisions. Additionally, GenMark has refined its cartridge manufacturing processes, ensuring an adequate supply and enhanced validity. The system offers tests for infectious diseases, focusing on panels for respiratory and bloodstream infections, which can progress to sepsis, and the company is developing panels for gastrointestinal infections, meningitis, and encephalitis. The cobas eplex system integrates the entire order-to-report process to maximize the ...
The COVID pandemic has dramatically reshaped the perception of diagnostics. Post the pandemic, a groundbreaking device that combines sample collection and processing into a single, easy-to-use disposable unit could revolutionize the way samples are collected for diagnostic tests. ReadyGo Diagnostics’ (Bath, UK) Sampler device incorporates both the swab and collection buffers into one device, making it exceptionally user-friendly. It is the world’s first universal tool of its kind that ensures convenience, reliability, and reproducibility right from the initial step of a diagnostic test. The patented technology behind the ReadyGo Sampler uses specially engineered materials that not only allow the device to collect the exact amount of sample required instantly but also rapidly break open viruses and bacteria, making them readily detectable in specific tests. The ReadyGo Sampler device is intended to be a more user-oriented alternative to conventional swab-based sample collection methods by combining sample collection and processing into one ...
Gonorrhea ranks as the second most commonly reported bacterial sexually transmitted infection (STI), with around 82 million global cases in 2020. The infection can lead to severe health consequences like pelvic inflammatory disease, chronic pelvic pain, and infertility. Many patients may not show symptoms, leading to underreported cases and highlighting the need for more accessible, accurate, and cost-effective diagnostic solutions. Now, a new point-of-care test aims to expand access to STI testing by providing affordable, accurate, and convenient diagnosis. Scout (Santa Clara, CA, USA) is developing the STI Scout test to identify and distinguish between Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). This new test delivers results in just 30 minutes at a cost expected to be less than half that of current testing methods. STI Scout can use either first void urine samples or vaginal swabs. The test runs on the Scout Hub device and is integrated with the ...
Artificial intelligence (AI) algorithms are increasingly being utilized in various clinical settings, such as dermatology. These algorithms are developed by training a computer with hundreds of thousands or millions of images of various skin conditions, each labeled with details like the diagnosis and patient outcomes. Through a process known as deep learning, the computer learns to identify patterns in the images that are indicative of specific skin diseases, including cancers. Once sufficiently trained, the algorithm can suggest potential diagnoses based on new images of a patient’s skin. However, these algorithms do not operate in isolation; they are used under the supervision of clinicians who evaluate the patient, make their own diagnostic assessments, and decide whether to follow the algorithm’s recommendations. Now, a new study led by researchers at Stanford Medicine (Stanford, CA, USA) has found that AI algorithms, which utilize deep learning, can enhance the accuracy of diagnosing skin cancers. ...
While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex chemical reactions which are crucial for amplifying viral DNA or RNA, a process that involves generating multiple copies of the genetic material that can also create and amplify error. Additionally, PCR tests can detect only nucleic acids, the material comprising DNA and RNA, but can be of great use in detecting other biomarkers such as proteins in the case of certain diseases. Now, a groundbreaking diagnostic system offers the ability to accurately identify SARS-CoV-2 and Zika virus with a precision matching or surpassing that of PCR tests, but significantly reducing the time and complexity involved in diagnosis. The new system developed at UC Santa Cruz (Santa Cruz, CA, USA) in collaboration with the Texas Biomedical Research Institute ...
A new fully automated multiplexing molecular diagnostic platform offers an innovative and cost-effective testing approach by allowing customization of tests along with the ability to process and pay for desired results, thus enabling laboratories to maximize testing efficiencies. Diasorin’s (Saluggia, Italy) new LIAISON PLEX platform provides complete flexibility for the customization of syndromic panels and helps overcome the challenge of the “one size fits all” approach faced by clinical laboratory staff for infectious disease syndromic diagnostics. Custom panels enable adjustments in response to seasonal changes and updates in clinical guidelines, helping prevent unnecessary and costly over-testing – a common issue with fixed, broad syndromic panels currently in use. The user-friendly, fully automated sample-to-answer system offers a streamlined workflow and room-temperature stable consumables, simplifying storage and transport logistics. Additionally, it requires just two minutes of hands-on time per sample and can deliver results in less than two hours. The LIAISON PLEX, ...
It is important for doctors to rapidly and accurately identify prevalent respiratory pathogens like COVID-19, influenza A and B, RSV-A, and RSV-B for administering prompt, tailored treatment to infected individuals. In a significant advancement, a near-patient test system using automation technology detects pathogens with unrivaled speed and cuts the typical waiting time of 24 to 48 hours to just one to two hours without the need for expensive biosafe laboratories. Fast MDx Limited (Middlesex, UK) and Festo (London, UK) have jointly designed and developed the world’s first, low-cost, high-throughput, near-patient molecular diagnostic test system that will provide clinicians with earlier, more informed results, allowing each patient to receive a faster, personalized clinical pathway. The Fast MDx system comprises everything necessary for testing, including sample tubes, swabs, and even electronic result transmission to the originating hospital, clinic, or doctor’s office. The system incorporates Fast MDx’s latest, ultra-fast, NGx2 4-Channel qPCR thermal ...
Gonorrhea, ranked as the second most reported bacterial sexually transmitted infection (STI), affected approximately 82 million people globally in 2020. The infection can lead to severe health complications, including pelvic inflammatory disease, chronic pelvic pain, and infertility. Untreated gonorrhea may progress to the bloodstream, posing a life-threatening risk and increasing the likelihood of HIV infection. Many cases go unreported due to asymptomatic patients, implying that the actual burden of the disease may be significantly higher. Now, a rapid test aims to identify gonorrhea and also determine its antibiotic susceptibility. Visby Medical (San Jose, CA, USA) has been awarded up to USD 1.8 million by CARB-X (Boston, MA, USA) for the development of a portable rapid polymerase chain reaction (PCR) diagnostic to identify the presence of Neisseria gonorrhoeae (NG), the pathogen responsible for gonorrhea, and ascertain its susceptibility to ciprofloxacin. Ciprofloxacin was once a primary oral antibiotic for treating NG but ...
Current point-of-care (POC) diagnostic technologies are typically limited to measuring a single disease biomarker or several biomarkers from the same class of molecules, such as various RNAs, proteins, or antibodies. However, the ability to measure multiple biomarkers from different molecular classes could provide a more comprehensive understanding of a disease’s state, severity, progression, and individual variations in its development. Electrochemical biosensors, which convert the chemical signal of a biomarker found in a small biofluid sample (like blood, saliva, or urine) into an electrical signal proportional to the biomarker’s amount, could potentially address many diagnostic challenges at the point of care. These sensors can be assembled into multiplexed arrays to detect different biomarkers, and recent advances have overcome the challenge of “biofouling” – the degradation of electrode surfaces by nonspecific biological molecules in samples – through the development of thin antifouling coatings. Now, researchers at Wyss Institute at Harvard University (Boston, ...
Systemic Lupus Erythematosus (SLE), widely known as lupus, is an autoimmune condition where the body’s immune system mistakenly attacks its own tissues and organs. This disease can lead to inflammation affecting various body parts, including joints, skin, kidneys, blood cells, brain, and heart. Among its manifestations, lupus nephritis stands out as one of the most severe and common, often resulting in significant morbidity and mortality. Early detection of kidney involvement in lupus patients and prompt intervention are critical in mitigating the associated pain, suffering, and potential fatality. Now, researchers have discovered new biomarkers with improved diagnostic performance for the early detection of lupus nephritis. In a significant advancement, a research team from the University of Houston (Houston, TX, USA) employed Proximity Extension Assay (PEA) proteomics—a method focused on the study of proteins in terms of their interactions, functions, compositions, and structures—on urine samples from lupus patients. This approach led to ...
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