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Handheld Device Puts Power of Lab-Based Diagnostic Testing in the Palm of Your Hand

Many common tests for infectious diseases work by detecting either antigens related to the virus or antibodies created in response to the infection. These tests, which now include widely used COVID-19 rapid antigen tests, offer the advantages of speed and broad availability. However, polymerase chain reaction (PCR) tests still surpass these in terms of accuracy, reaching nearly 100%. PCR tests, considered the gold standard in infectious disease diagnostics, excel because they detect a pathogen’s genetic material like RNA directly. This capability increases specificity, reducing the likelihood of false positives. PCR can also amplify minimal amounts of genetic material, allowing it to detect infections at very low levels. Yet, PCR requires specialized skills and expensive equipment, which limits its availability, particularly in low-resource settings. Researchers at the University of Connecticut (Storrs, CT, USA) have now developed a platform technology that incorporates PCR-like capabilities within a handheld device, as detailed in ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801920/handheld-device-puts-power-of-lab-based-diagnostic-testing-in-the-palm-of-your-hand.html
- 124
- July 26, 2024
AbbVie looks to add an eighth indication for JAK inhibitor Rinvoq

AbbVie is set to expand the indication list for its immunology blockbuster, Rinvoq (upadacitinib). The company has submitted applications to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to seek approval for the use of Rinvoq as a treatment for giant cell arteritis. Rinvoq blocks the activity of Janus kinase (JAK) enzymes in the JAK-STAT signalling pathway, which plays a role in the release of pro-inflammatory cytokines. It has been approved by the FDA to treat seven autoimmune conditions, namely atopic dermatitis, ankylosing spondylitis, axial spondylarthritis, Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Rinvoq is one of the top revenue-generating therapies for AbbVie, raking in approximately $4bn in sales last year, per the company’s financials. The therapy’s revenue is expected to soar over the next decade, with Rinvoq expected to pull in over $12bn in sales by 2030, as ...
- Source: https://www.pharmaceutical-technology.com/news/abbvie-looks-to-add-an-eighth-indication-for-jak-inhibitor-rinvoq/
- 89
- July 17, 2024
Delix plans further trials with neuroplastogen after positive Phase I data

Delix Therapeutics is planning to initiate two studies to evaluate patients with major depression investigating its lead neuroplastogen candidate, DLX-001, Delix CMO Dr. Aaron Koenig told Pharmaceutical Technology. Upon the completion of an ongoing Phase I study, the Bedford, Massachusetts-based biotech will take the small molecule into two planned trials—a Phase Ib study and a Phase II study, Koenig said. DLX-001 is a neuroplastogen designed to promote neuroplasticity without giving rise to the deleterious attributes of first- and second-generation psychedelics. “With many psychoactive drugs, you’re talking about the concentrations that you’re able to maintain, continuously engaging the receptor for some period of time. We think that this [DLX-001] has a Cmax-driven effect, meaning that it’s about flipping the switch on the receptor so that downstream effects can then occur,” said Koenig. In May, the company released Phase I data, which demonstrated that treatment with DLX-001 does not produce any psychedelic ...
- Source: https://www.pharmaceutical-technology.com/news/delix-plans-further-trials-with-neuroplastogen-after-positive-phase-i-data/?cf-view
- 95
- July 17, 2024
Innovate UK grants £4m to four companies to evaluate biomarkers for dementia

The progressive neurodegenerative disease affects more than 55 million people globally Innovate UK has awarded £4m through its Contracts for Innovation to four UK companies for research into dementia diagnosis. As part of the Bio-Hermes-002 study led by the US-based Global Alzheimer’s Platform Foundation (GAP) in partnership with Novo Nordisk, the organisations will evaluate blood-based and digital innovative biomarkers for the neurological condition. Affecting more than 55 million people globally, which is expected to triple by 2050, dementia is a neurodegenerative condition that affects the ability to remember, think or make decisions in everyday life. The study aims to explore whether these biomarkers can predict the extent of tau and amyloid brain pathology and potentially provide more efficient and less invasive alternatives to the current gold standard for dementia diagnoses: positron emission tomography brain imaging. The project will involve 1,000 participants who are cognitively normal, have mild cognitive impairment or ...
- Source: https://www.ukri.org/news/uk-and-us-join-forces-to-tackle-dementia-with-innovative-biomarkers/
- 100
- July 17, 2024
UK Researchers developing new tetanus test to identify global immunity gaps

The serious, rare condition is responsible for up to 7% of all neonatal deaths globally Researchers from the University of Birmingham are developing a new blood-free test to help identify children across the Global South missing immunity to tetanus and other essential vaccines. Supported by £1.1m of funding by the Medical Research Council, the low-cost, non-invasive saliva lateral flow test can potentially reveal whether a person has protection against tetanus within just 15 minutes. Estimated to be responsible for up to 293,000 deaths worldwide every year, according to the European Centre for Disease Prevention and Control, tetanus is a serious disease of the nervous system caused by a toxin-producing bacterium, Clostridium tetani, and is responsible for up to 7% of all neonatal deaths globally. Newborn tetanus is a rare condition that occurs in infants most often within the first ten days of life, resulting from an infection in the umbilical ...
- Source: https://pharmatimes.com/news/uk-researchers-developing-blood-free-tetanus-test-to-identify-global-immunity-gaps/
- 124
- July 17, 2024
Multiplex PCR Test Detects Common Viral and Bacterial Causes of Respiratory or Sore Throat Infections in 15 Minutes

The COVID-19 pandemic has created the need for healthcare professionals to employ diagnostic tests as close as possible to the patient and provide rapid actionable results. An increasing number of tests are conducted outside hospital labs directly in Emergency Departments (ED) or at the Point of Care (POC). This market is especially active in the U.S. Now, a fast and innovative syndromic testing solution perfectly matches these new medical needs. bioMérieux’s (Marcy-l’Étoile, France) BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has obtained U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). Designed for use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections in around 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801818/multiplex-pcr-test-detects-common-viral-and-bacterial-causes-of-respiratory-or-sore-throat-infections-in-15-minutes.html
- 80
- July 17, 2024
Smartphone-Controlled Microfluidic Device Enables Rapid Influenza Detection

The influenza virus represents a significant public health concern, annually causing epidemics with high morbidity and mortality rates. The virus is known for its high mutation rate and the existence of multiple subtypes, which require varied clinical approaches. Consequently, there is a critical need for an accurate, rapid, and portable method to differentiate between influenza virus subtypes to manage virus transmission and inform clinical treatment decisions. Researchers have now developed a spatial encoding of a centrifugal microfluidic disc-integrated smartphone-controlled (SEDphone) platform for detecting influenza virus subtypes. In a study, researchers from the Hefei Institutes of Physical Science of the Chinese Academy of Sciences (Anhui, China) developed a novel approach that combines Loop-mediated Isothermal Amplification (LAMP) with CRISPR/Cas12a technologies for rapid and accurate detection of various influenza viruses. This method amplifies target sequences using LAMP and detects them through CRISPR/Cas12a-mediated trans-cleavage activity, thus cleaving reporter probes and emitting fluorescent signals. ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801817/smartphone-controlled-microfluidic-device-enables-rapid-influenza-detection.html
- 94
- July 17, 2024
FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia

By Don Tracy, Associate Editor DSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability. Image Credit: Adobe Stock Images/Pichitchai The FDA has granted Fast Track Designation to Sumitomo Pharma America’s DSP-5336, an investigational small molecule inhibitor for the treatment of relapsed or refractory acute myeloid leukemia (AML) with KMT2A rearrangement (MLLr) or nucleophosmin mutation (NPM1m). According to the company, DSP-5336 targets the menin and mixed-lineage leukemia (MLL) protein interaction, which is considered vital in a variety of biological processes, including cell growth and genomic stability.1 “For patients and families facing a diagnosis of relapsed or refractory acute myeloid leukemia, significant unmet medical needs remain—and we share in their urgency to identify and advance new treatment pathways,” said Tsutomu Nakagawa, PhD, president, CEO, SMPA, in a press release. “We are encouraged by FDA’s decision and look forward to working closely ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
- 112
- July 17, 2024
Positive Data in Pancreatic Cancer Pave Way for Pivotal Test of Revolution Medicines Drug

Revolution Medicines drug RMC-6236 increased progression-free survival in patients with advanced cases of pancreatic ductal adenocarcinoma. With these results, the biotech is preparing for a Phase 3 clinical trial in this indication, the most common type of pancreatic cancer. By Frank Vinluan Pancreatic cancer remains one of the toughest cancers to treat, but Revolution Medicines has data from an early-stage study showing its experimental treatment helped patients live longer without their disease worsening. With these encouraging results, Revolution said Monday it is preparing to proceed to a pivotal clinical trial enrolling patients with advanced cases of the most common type of pancreatic cancer. Revolution develops therapies that target the RAS family of proteins, validated but elusive targets for cancer drug research. Mutations to these proteins lead to the uncontrolled cell growth that happens in a variety of cancers. The most advanced program from Redwood City, California-based Revolution is RMC-6236. This small molecule is ...
- Source: https://medcitynews.com/author/fvinluan/
- 84
- July 17, 2024
Urine Test to Revolutionize Lyme Disease Testing

Lyme disease is the most common animal-to-human transmitted disease in the United States, with around 476,000 people diagnosed and treated annually, and its incidence has been increasing. If not addressed promptly and effectively, those affected may experience persistent symptoms known as Post-Treatment Lyme Disease Syndrome, which include issues with concentration and memory, dizziness, fatigue, body aches, depression, and sleep disturbances. Currently, the standard diagnostic approach involves an antibody blood test that detects the immune system’s response to the bacteria responsible for Lyme disease. Now, urine testing could revolutionize Lyme disease detection and diagnosis thanks to its many advantages over existing techniques. Researchers at George Mason University (Fairfax, VA, USA) have developed a urine test for Lyme disease that detects the Borrelia bacteria, which causes Lyme disease. This advancement allows for the confirmation of an infection shortly after a tick bite, leading to timely treatment and helping to avoid the ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294801060/urine-test-to-revolutionize-lyme-disease-testing.html
- 108
- May 4, 2024

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