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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
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- May 4, 2024
Robotic Blood Drawing Device to Revolutionize Sample Collection for Diagnostic Testing

Blood drawing is performed billions of times each year worldwide, playing a critical role in diagnostic procedures. Despite its importance, clinical laboratories are dealing with significant staff shortages, which impact their ability to deliver timely test results and maintain satisfactory patient care. Now, an innovative robotic blood drawing device for the medical laboratory market could help ease staff workload and provide a more consistent patient experience. Developed by Vitestro (Utrecht, The Netherlands), this innovative blood-drawing device is designed to perform safe and accurate blood draws. It utilizes artificial intelligence (AI) for ultrasound-guided 3D reconstruction and ensures submillimeter precision in needle insertion. This high level of accuracy and consistency in blood collection is achieved through a combination of AI, advanced imaging technologies, and robotics. By automating blood draws, Vitestro’s device not only reduces the physical demand on staff but also enhances the satisfaction of both patients and healthcare providers. The ...
- Source: https://www.labmedica.com/pathology/articles/294801059/robotic-blood-drawing-device-to-revolutionize-sample-collection-for-diagnostic-testing.html
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- May 4, 2024
FDA Approves New Herceptin Biosimilar for the Treatment of Multiple HER2-Overexpressing Cancers

Don Tracy, Associate Editor Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers. Image Credit: Adobe Stock Images/Saiful52 Accord BioPharma announced that the FDA has approved Hercessi (trastuzumab-strf), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast and gastric cancers. The treatment is also approved for metastatic gastric or gastroesophageal junction adenocarcinoma. According to the company, the approval was based on promising data that showcased Hercessi’s biosimilarity to Herceptin when it came to efficacy, safety, and quality. This includes three studies, one being a Phase III clinical efficacy study, and the other two being Phase 1 PK equivalence studies. All trials displayed safety profiles on par with Herceptin.1 “The approval of Hercessi—our first biosimilar to be approved in the US—marks an important milestone for Accord BioPharma in our efforts ...
- Source: https://www.pharmexec.com/authors/don-tracy-associate-editor
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- May 4, 2024
Drug Licensed from Sanofi Becomes First FDA-Approved Therapy for Ultra-Rare Primary Immunodeficiency

The FDA approved X4 Pharmaceuticals drug Xolremdi for treating WHIM syndrome. The molecule, which addresses the underlying cause of this rare immunodeficiency, was licensed from Sanofi’s Genzyme subsidiary. By Frank Vinluan A primary immunodeficiency whose rarity means it can go undiagnosed or misdiagnosed in a patient for years now has its first drug. The FDA has approved a once-daily therapy that addresses the underlying genetic problem driving the inherited disorder, known as WHIM syndrome. The regulatory decision announced Monday for the X4 Pharmaceuticals drug covers WHIM patients age 12 and older. The daily capsule, known in development as mavorixafor, will be commercialized under the brand name Xolremdi (pronounced “zohl-REM-dee”). The name WHIM is an acronym for warts, hypogammaglobulinemia, infections, and myelokathexis, which are the four common clinical presentations of the disease. But the disease is not limited to those symptoms and it presents differently from one patient to another. There is no standard ...
- Source: https://medcitynews.com/author/fvinluan/
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- May 4, 2024
Cardinal receives FDA warning letter over unapproved syringes

Dive Brief Cardinal Health marketed convenience kits that include piston syringes not authorized by the Food and Drug Administration, the agency said in an April 24 warning letter. The agency found the violations during an inspection of Cardinal’s facility in Waukegan, Illinois. Cardinal distributed syringes made by Jiangsu Shenli Medical Production with “substantially different technological characteristics” than those cleared by the FDA, according to the letter. Cardinal has come under scrutiny after the company recalled some of its disposable syringes last year because their dimensions had changed, making them incompatible with certain infusion pumps. The FDA has also taken steps to block plastic syringes made by Jiangsu Shenli from being imported. Dive Insight The warning letter focuses on Cardinal’s Monoject luer-lock tip syringes, which are intended to inject fluids into the body or withdraw fluids, and Monoject enteral feeding syringes, which deliver fluid, food or medications to ...
- Source: https://www.medtechdive.com/news/cardinal-warning-letter-unapproved-syringes/714934/
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- May 4, 2024
Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases

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 ...
- Source: https://www.labmedica.com/microbiology/articles/294801045/enhanced-rapid-syndromic-molecular-diagnostic-solution-detects-broad-range-of-infectious-diseases.html
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- May 4, 2024
AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...
- Source: https://www.expresspharma.in/astrazenecas-lynparza-to-dominate-parp-inhibitors-market-with-4-bn-in-sales-by-2027-globaldata/
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- May 4, 2024
BD India’s Venous Summit focus on best practices for better patient care

Attended by 200+ delegates with 13 case-presenters who drove 8.5 hours of scientific discussions each day, the end-objective of the Summit was to discuss best domestic and international practices in order to drive better patient care in venous domain in India To create awareness and enable knowledge-sharing around Venous diseases, in order to drive better patient care, BD (Becton, Dickinson, and Company) conducted roadshows across New Delhi, Mumbai and Bangalore recently. Venous disease is a condition where the veins in the body have difficulty returning blood to the heart, thereby resulting in blood clot forming in a vein, typically in the legs. If left untreated, these clots can break loose and travel to the lungs, causing serious complications. Delayed detection and intervention can lead to worsened clinical outcomes and a multitude of problems for both patients and healthcare professionals. The 3-day Venous Summit witnessed a series of Technology Innovation Forums ...
- Source: https://www.healthpartners.com/ucm/groups/public/@hp/@public/documents/documents/entry_191059.pdf
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- May 4, 2024
Senseonics gets FDA clearance to pair CGM implant with insulin pumps

Dive Brief Senseonics has received an integrated continuous glucose monitoring (iCGM) designation from the Food and Drug Administration, the company said Tuesday. The designation, which the FDA granted via its de novo pathway, clears Senseonics to integrate its implantable CGM with pumps as part of automated insulin delivery systems. Senseonics’ sales are small compared to the CGM leaders Abbott and Dexcom, but BTIG analysts said the iCGM designation and planned one-year sensor could help the device appeal to a broader patient population. Dive Insight Senseonics’ Eversense device is a CGM implant that replaces fingerstick blood glucose measurements. The current device continually measures glucose levels for up to 180 days but requires daily calibrating with a fingerstick after day 21 and when symptoms do not match CGM information. Abbott and Dexcom sell shorter-lasting patches that dominate the CGM space. The iCGM designation allows Eversense to integrate with ...
- Source: https://www.medtechdive.com/news/senseonics-fda-clearance-integrated-cgm/714804/
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- May 3, 2024
Asimov achieves 10x improvement in lentiviral production, launches new stable cell line development service

Asimov, the synthetic biology company advancing the design and manufacture of therapeutics, today announced the expansion of its LV Edge System with the launch of a fully stable cell line development service. There are now two ways for customers to access Asimov’s cell line technology to minimize cost and manufacturing risk, depending on their needs: The LV Edge Packaging System, launched earlier this year, which enables a single plasmid transfection that achieves E8 TU/mL. The new, fully-stable LV Edge Producer cell line development service, which generates clones that achieve E9 TU/mL with no transient transfection required. The LV Edge Producer System completely eliminates GMP plasmid cost and greatly reduces process complexity and variability by stably integrating all the genes for lentiviral production into the host cell. Current processes for lentiviral production are inherently scale-limited and variable due to the need for multi-plasmid transient transfection. Furthermore, the ...
- Source: https://www.news-medical.net/news/20240430/Asimov-achieves-10x-improvement-in-lentiviral-production-launches-new-stable-cell-line-development-service.aspx
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- May 3, 2024

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