LGC Clinical Diagnostics’ Post

In this month's Science Spotlight, a team from Germany validated the TruSight Oncology 500 ctDNA assay using reference and patient samples, including Seraseq® ctDNA Reference Material v2 AF1% and Seraseq® ctDNA Reference Material v2 AF0.5%. They demonstrated high sensitivity and low variant detection variability of the assay for SNVs, insertions, deletions and fusions down to a VAF of 0.5% in the reference samples, and the VAFs were concordant with previous dPCR results in patient samples. Interestingly, the sensitivity and variability were dependent on the reference material used, with the Seraseq® ctDNA reference materials resulting in much lower variability and better reported sensitivity. Read the full article here to learn more about their findings! https://hubs.ly/Q02pljLn0

NGS analytical assay validation, especially of already well-established platforms, rarely takes the spotlight, often tucked away in supplementary materials behind clinical data. But it's a crucial prerequisite to establishing clinmical validity and utility of any test, especially in liquid biopsy. It's refreshing to see a paper which takes validation seriously, uses multiple available reference materials on the market, and looks deeper into the details of technical performance! #ngs #liquidbiopsy #validation

Get predictive datasets for therapeutic efficacy and MOA in weeks not months! DM me to start a discussion about your study today!

Medicus Pharma, led by Dr. Raza Bokhari, has submitted an updated Phase 2 clinical protocol to the FDA for a novel treatment targeting basal cell carcinoma. The protocol leverages micro-needle arrays containing doxorubicin, developed by Skinject, Inc., a subsidiary of Medicus Pharma. The submission incorporates enhancements to Chemistry, Manufacturing, and Controls (CMC), stability, and sterility data, addressing previous FDA comments. Notably, it introduces artificial intelligence and confocal microscopy as supplementary endpoints at one clinical site, promising deeper insights into treatment outcomes. 'This updated protocol is well-positioned to receive FDA approval, allowing us to commence participant randomization potentially before the end of this quarter,' stated Dr. Bokhari. The submission underscores Medicus Pharma's commitment to advancing innovative skin cancer treatments through rigorous clinical research and cutting-edge technology. @medicuspharma #skincancer #clinicaltrials #innovation

An Allosteric Pan-Mutant-Selective PI3Kα Inhibitor Without Hyperglycemia in Preclinical Models | https://lnkd.in/gu9AyiXH RLY-2608 is an oral, mutant-selective PI3Kα allosteric inhibitor from Relay Therapeutics, targeting a cryptic pocket near the ATP-binding site. Given the challenges and toxicities associated with WT PI3Kα inhibition—such as hyperglycemia and rash—there's an increasing need for next-generation, mutant-selective PI3Kα inhibitors. Relay Therapeutics recently shared promising interim data from the Phase I ReDiscover trial in patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer. Explore this case study on RLY-2608 to dive into the discovery strategy, mechanisms driving mutant selectivity, its position in the competitive landscape, preclinical activity, recent clinical developments, and more. Full Article: https://lnkd.in/gu9AyiXH

A Next-Generation, Mutant-Selective PI3Kα Allosteric Inhibitor from Scorpion Tx with a Potentially Improved Safety Profile | https://lnkd.in/grrEWg7b STX-478 is an oral, CNS-penetrant, WT-sparing allosteric inhibitor of mutant PI3Kα, a key player in many cancers. The selectivity profile of this compound may be a key differentiator in the clinic by avoiding the metabolic dysfunction seen in current generation pan-PI3Kα inhibitors. Scorpion Therapeutics recently highlighted promising efficacy and safety data for STX-478 in their ESMO 2024 presentation, including key hyperglycemia data which we’ve covered in this updated article! This full case study explores the discovery and lead optimization of STX-478, its pharmacology, preclinical and clinical data, and how it compares to other PI3Kα inhibitors in the field. Read it on Drug Hunter | https://lnkd.in/grrEWg7b

On World Cancer Day, we are all reminded of the bravery of our most critical patients and how crucial it is to provide the best healthcare possible for patients everywhere. At Sysmex, we are dedicated to developing innovative analyzers to help clinical labs provide accurate results regardless of the diagnosis. White Precursor Cell (WPC) testing on the XN-20™ hematology module offers automated, next-level analysis of white blood cells, giving highly skilled laboratory scientists sensitive and specific flagging for the crucial identification of abnormal cells. Efficiency can be gained when WPC testing is reflexed using the XN analyzer’s onboard rules or Caresphere™ Workflow Solution (WS). For more information on how Sysmex can help your laboratory help provide diagnostic testing for critical patients, contact your Sysmex Sales Representative or visit https://ow.ly/nYb450QxtNh. *XN analyzers are FDA-cleared to classify and count blood cells. #WorldCancerDay #Sysmex #Hematology #TogetherForABetterHealthcareJourney

Megan Webster, PhD, Principal Scientist, presenting at The 3Rs Collaborative (3RsC) Neuromuscular & Fibrosis MPS workshop today on: 📌 'Utilisation of high-content imaging for the study of lung fibrosis.' By leveraging the ability to image multiple fluorophores at high-throughput we are able to provide insight into drug-induced changes in matrix proteins which are known to contribute to the pathophysiology of lung fibrosis, enabling high-throughput screening of anti-fibrotic therapeutics. Find out more about our Fibroblast-to-Myofibroblast Transition (FMT) Assay here: https://lnkd.in/ePdxzcZm #Lung #Fibrosis #MPS #FMT

Ratio’s fully integrated proprietary R&D platforms, Trillium™ and Macropa™, harness the tumor-killing power of the alpha emitting radionuclide actinium-225 to selectively destroy #cancer cells. Ratio’s Trillium™ technology is a proprietary and innovative platform that modulates drug pharmacokinetics (PK) and improves drug availability, tumor delivery, and tumor loading, while simultaneously reducing the side effects commonly observed with other radiotherapies. Learn more: https://lnkd.in/e--KTJiH #radiopharmaceuticals #theranostics

🔍 How do you benchmark gold standard practice when selecting your assays to measure ctDNA? With 144 ctDNA assays to choose from, ensuring that you select the best assay to suit your upcoming trials is critical for success. Below, I have attached a Case Study 📊 of how our Beacon team has developed their optimal framework for assay selection. When it comes to delivering better precision medicine outcomes to patients, the LBx team over at Hanson Wade wants to ensure that knowledge is freely shared and built upon. Therefore, at this year's Liquid Biopsy for Precision Oncology Summit, it will be free to attend for all senior representatives from Biotech and Pharma companies. We'll be hosting talks from AbbVie, Foundation Medicine, Genentech, ESSA Pharma, Natera, and Labcorp on how they Build, Improve, Leverage, Stratify, and Optimize ctDNA assays. If you would like to learn more about the exclusive content that we will be showcasing at this year's summit, please feel free to check out this year's agenda linked here: https://lnkd.in/ebQU58pS And if you are interested in securing free passes for you and your team, please reach out directly to me for more information. 📅 p.s. 02/12 will be the final day you will be able to secure discounted accommodation at the Hilton La Jolla Torrey Pines, with the onsite golf course where the likes of Barack Obama and Tiger Woods have played. Please let me know if you are interested in learning more. #lbx #ctdna #liquidbiopsy #precisionmedicine #cdx #oncology 🧬🌐