Exact Sciences’ Post

The future of cancer detection is bright.

Dr. Alberto Gutierrez will be co-chairing the “Regulatory Strategies for Point-of-Care Diagnostics Special Forum” at the 16th Annual Next Generation Dx Summit in Washington, DC on August 20th. The forum begins with a keynote presentation entitled “Updates on US FDA POC Test Regulations” presented by Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health (FDA). A panel discussion entitled “Regulatory Strategies for Point-of-Care Diagnostics: Learning from Success Stories and Avoiding Pitfalls” and plenary fireside chat entitled “Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward” feature FDA regulators including Courtney H. Lias, PhD, Acting Director, OHT7: Office of in vitro Diagnostic Devices (FDA), and industry experts. Join the discussion to learn more about the essential components and nuances that are pivotal for regulatory approval for point-of-care diagnostics. #ndapartners #diagnostics #FDA #IVD #LDTs #laboratorydevelopedtests #NGDx #IVDR #regulatorysciences https://lnkd.in/d_z6tMBP.

What do you know about the newly developed scientific guidance on drug-drug interaction (DDI) studies? We have all the information about how it affects your #drugdevelopment program – get it here: https://bit.ly/4bbh3Xo #ICHM12 #DrugDrugInteractionGuidance

🥁 FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs). These tests will now fall under the same enforcement approach as FDA takes with other in vitro diagnostics (IVDs), which FDA believes will better protect the health and safety of patients who rely on the results of LDTs. (The Final Rule will be published in the Federal Register on May 6, 2024, but a PDF version is available leading up to that date.) Check out this blog to find out what's changing and why, stages and what to expect: https://bit.ly/3URWydH #fda #ldt #ivd #finalrule #medtech #greenlightguru #21cfrpart809

📌 FDA has officially announced their Final Rule regarding the phaseout of enforcement discretion for laboratory developed tests (LDTs). These tests will now fall under the same enforcement approach as FDA takes with other in vitro diagnostics (IVDs), which FDA believes will better protect the health and safety of patients who rely on the results of LDTs. This is a huge change for the labs that make LDTs ‼️ 👀 And while it has been in the works for years, it’s essential that everyone affected understands the fundamentals of the new enforcement framework and how it will impact their work. So in this featured article, we're going to lay out the basics of the rule: what’s changing and how the change will be implemented. Check it out: https://hubs.ly/Q02Dn4QM0 #ldt #laboratorydevelopedtests #ivds #medtech #fda #finalrule #greenlightguru

The In-Vitro Diagnostic Regulation (IVDR) is highly impacting the in vitro diagnostic landscape, as well as relevant to laboratories using their own in-house testing (LDTs). With its extensive experience and knowledge, Tecan has multiple products IVDR certified, enabling seamless product offerings for clinical laboratories in highly regulated markets. We are happy to share our knowledge and invite everyone to join the webinar from the IVDR leaders where Magali Wolff (Tecan) and Fabian Reijn (Diagnotix) will speak about the following topics: • What is IVDR and what are the timelines? • What are the requirements for in-house tests (LDTs)? • What are the next steps for your lab? The webinar is organized by Sciex. Register now, and stay up to date with the IVDR requirements relevant to your lab: https://lnkd.in/dpd-mUMn #lcms #IVDR #Tecan

Excited to share this upcoming webinar hosted by MSACL! As someone involved in clinical diagnostics, I've come to appreciate the significance of staying updated on regulatory requirements, particularly with the IVDR's impact on LDTs and LC-MS labs. Join Fabian Reijn and me on April 18 to explore how these changes will shape the future of diagnostic practices. Register now to secure your spot! #lcms #IVDR #Tecan

CALLING THE COMPANION DIAGNOSTIC COMMUNITY Companion diagnostic regulation is critically challenging biopharma due to Europe's IVDR confusion, uncertainty about LDT reclassification, and fear around upcoming FDA updates. This summer, there’s one essential event to navigate these global regulatory changes, tackle reimbursement and policy issues, reduce submission risks, and ensure timely access to safe and effective companion diagnostics worldwide. Secure your spot in the room now at the World CDx Regulatory Affairs & Policy Summit to make sure you have a role in collaborating with key decision makers, influencing the policies that will shape CDx regulation & reimbursement indefinitely: https://ter.li/j2phi9 Jai Pandey, PhD, Vihanga Pahalawatta, Lori Roadcap, Andrea Renninger, Claudia Dollins Mary J. Savage, Deb Rasmussen, Ralph Riley, Dun Liang, Andrew L'Huillier, Sid Mathur, Qing Li, MD. PhD, Hannah O. Edward, Kaska (Katarzyna) Kowanetz, PhD, RAC, Brian Baker