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Diagnostics World | Roche announced the completion of the acquisition of LumiraDx’s Point of Care technology; NOWDiagnostics announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to its First To Know Syphilis Test for OTC use; MAUI Imaging emerged from stealth with the announcement of a $4 million U.S. Department of Defense (U.S. Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care; and more.
Aug 28, 2024
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Diagnostics World | A final rule on laboratory-developed tests (LDTs) released by the U.S. Food and Drug Administration (FDA) in early May has done little to settle the longstanding debate about how LDTs ought to be regulated. The rule clarifies that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act, even when the manufacturer is a laboratory, and establishes a framework for FDA oversight of LDTs inclusive of a policy to phase out the agency's "enforcement discretion" policy.
Aug 26, 2024
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Diagnostics World | For clinical laboratories, keeping up with the changing landscape of carrier screening has been quite challenging lately. A maze of ancestry-based screening guidelines has been replaced with new guidelines that call for screening an order of magnitude of more genes.
Aug 23, 2024
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Diagnostics World | Theranos comparisons are generally not favorable, but Babson Diagnostics has now rolled out blood testing that achieves what Theranos claimed to: needle-free, small-volume blood testing, from the convenience of retail pharmacies.
Aug 21, 2024
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Diagnostics World | New technology, powered by artificial intelligence (AI), aims to bring breast and ovarian cancer patients the expected value of genomic sequencing—a more precise diagnosis and personalized treatment strategy—potentially without ever having their DNA analyzed.
Aug 20, 2024
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Diagnostics World | Last week, Paige, in collaboration with Microsoft, unveiled the second generation of Virchow, its million-slide foundation model for cancer. Virchow2 and Virchow2G offer a deeper understanding of cells and tissue, aiming to redefine cancer diagnosis and treatment.
Aug 16, 2024
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Diagnostics World | In recent months, Diagnostics World has taken a look at new developments taking place in the field of sarcoidosis research, including progress made toward a simple blood test and new treatment options as well as efforts to gain a better understanding of cardiac sarcoidosis in particular. Here, we explore the role of philanthropic funding, highlight research projects and collaborative initiatives, and sum up efforts to improve clinical trial diversity.
Aug 15, 2024
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Diagnostics World | Researchers at The Australian National University (ANU) have developed a deep learning algorithm, known as DEPLOY, to classify central nervous system tumors into 10 major categories from histopathology images. The goal is to optimize treatment with a faster, more accessible diagnostic approach than the state-of-the-art practice of DNA methylation-based profiling, which can take weeks.
Aug 13, 2024
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Diagnostics World | Obstructive sleep apnea (OSA) is a sleep disorder associated with major cardiovascular complications. Despite being a common sleep disorder, there has not been an effective drug treatment for patients. Fortunately, a team from the University of California San Diego School of Medicine recently published a drug repurposing study that may offer hope.
Aug 8, 2024
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Diagnostics World | Companion diagnostics (CDx) have revolutionized the treatment of cancer by helping to improve the safety and tolerability of targeted drugs—a key feature of precision medicine. The U.S. Food and Drug Administration (FDA) has to date approved nearly 180 CDx, many for rare diseases but only four of those outside of oncology.
Aug 7, 2024
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Diagnostics World | GE HealthCare and Amazon Web Services have announced a strategic collaboration to develop purpose-built foundation models and generative artificial intelligence (AI) applications designed to help clinicians improve medical diagnostics and patient care.
Aug 6, 2024
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Diagnostics World | Evidence is mounting that public health in the U.S. could get a big boost by better engaging community pharmacists in providing acute and chronic care services. These are highly trained clinicians in “extremely accessible” locations no more than five miles from the home of 95% of Americans.
Aug 1, 2024
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Diagnostics World | A study published in JAMA yesterday suggests blood tests can more accurately detect Alzheimer’s disease than physicians, and points to a way forward for more extensive Alzheimer’s testing. More blood testing developments are on display at this week's Alzheimer’s Association International Conference.
Jul 29, 2024
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Diagnostics World | Researchers at The Australian National University (ANU) have developed a deep learning algorithm, known as DEPLOY, to classify central nervous system tumors into 10 major categories from histopathology images. The goal is to optimize treatment with a faster, more accessible diagnostic approach than the state-of-the-art practice of DNA methylation-based profiling, which can take weeks.
Jul 25, 2024
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Diagnostics World | Element Biosciences nets $277 million to launch combined sequencing and cyto-profiling platform; NOWDiagnostics raises $22.5 million for at-home diagnostic tests; and more.
Jul 24, 2024
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Diagnostics World | A new web-based platform aims to standardize the care of rare disease patients in a wide range of settings and accelerate their diagnostic journey. The Rare Disease Clinical Activity Protocols (RareCAP) is effectively a collection of the latest research-based information and guidance about some of the more than 7,000 conditions affecting a small number of people.
Jul 23, 2024
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Diagnostics World | Most of the time, sarcoidosis appears in the lungs and lymph nodes, but the heart is impacted in a smaller number of patients. Known as cardiac sarcoidosis (CS), this rare condition can lead to serious complications like arrhythmia or heart failure. Recently, Diagnostics World covered efforts to improve diagnostic and treatment options for sarcoidosis.
Jul 18, 2024
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Diagnostics World | A recent analysis of interventional clinical trials by the Tufts Center for the Study of Drug Development (CSDD) has found that use of digital endpoints has been growing rapidly since 2015 with drug developers now initiating an average of about 35 such studies each year. News of the uptick isn’t entirely surprising, given mounting evidence that the approach can improve operational performance and ease patient burdens in clinical trials and in clinical practice, while [potentially] yielding financial net benefits to developers.
Jul 16, 2024
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Diagnostics World | For more than 150 years now, medical scientists have been hunching over microscopes turning human tissue samples into crisp colored images that help pathologists diagnose diseases. Histology, as the field is known, has made an art of the complex business of creating high-quality microscope slides—and until recently done it in precisely the same way with consistently good results.
Jul 11, 2024
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Diagnostics World | Machine learning models can be superior to radiologists when it comes to processing complex images and putting a predictive label on them, particularly at scale. The problems currently being studied in biomedicine with machine learning, such as identifying the subtype of cancer a patient has, are ones that have been largely ignored for a long time.
Jul 10, 2024