Danaher Corporation’s Post

We are proud to share that the FDA has granted De Novo marketing authorization with CLIA Waiver for the Cepheid Xpert HCV test, the first capillary whole blood (fingerstick) point-of-care RNA test for Hepatitis C Virus (HCV). This test, supported by DCN Dx’s clinical research, simplifies the HCV testing process, delivering results within one hour and enabling same-visit diagnosis and treatment initiation. The NIH-FDA Independent Test Assessment Program (ITAP) played a pivotal role in this achievement. Our collaboration with NIH-FDA ITAP, Cepheid, and participating clinical sites was crucial in ensuring the test’s timely evaluation and authorization. Kudos to Cepheid on this milestone! We are honored to have contributed to the clinical research that supported the NIH-FDA ITAP program and the successful De Novo authorization of the Xpert HCV test. To learn more, read the release here: https://hubs.ly/Q02G2lTk0 #IVD #Diagnostics #RapidTesting #PointofCare #HealthcareInnovation #PublicHealth #ClinicalResearch #CRO #FDAAuthorization #HCV #Cepheid #DCNDx

We are proud to share that the FDA has granted De Novo marketing authorization with CLIA Waiver for the Cepheid Xpert HCV test, the first capillary whole blood (fingerstick) point-of-care RNA test for Hepatitis C Virus (HCV). This test, supported by DCN Dx’s clinical research, simplifies the HCV testing process, delivering results within one hour and enabling same-visit diagnosis and treatment initiation. The NIH-FDA Independent Test Assessment Program (ITAP) played a pivotal role in this achievement. Our collaboration with NIH-FDA ITAP, Cepheid, and participating clinical sites was crucial in ensuring the test’s timely evaluation and authorization. Kudos to Cepheid on this milestone! We are honored to have contributed to the clinical research that supported the NIH-FDA ITAP program and the successful De Novo authorization of the Xpert HCV test. To learn more, read the release here: https://hubs.ly/Q02G2FHq0 #IVD #Diagnostics #RapidTesting #PointofCare #HealthcareInnovation #PublicHealth #ClinicalResearch #CRO #FDAAuthorization #HCV #Cepheid #DCNDx

We are proud to share that the FDA has granted De Novo marketing authorization with CLIA Waiver for the Cepheid Xpert HCV test, the first capillary whole blood (fingerstick) point-of-care RNA test for Hepatitis C Virus (HCV). This test, supported by DCN Dx’s clinical research, simplifies the HCV testing process, delivering results within one hour and enabling same-visit diagnosis and treatment initiation. The NIH-FDA Independent Test Assessment Program (ITAP) played a pivotal role in this achievement. Our collaboration with NIH-FDA ITAP, Cepheid, and participating clinical sites was crucial in ensuring the test’s timely evaluation and authorization. Kudos to Cepheid on this milestone! We are honored to have contributed to the clinical research that supported the NIH-FDA ITAP program and the successful De Novo authorization of the Xpert HCV test. To learn more, read the release here: https://hubs.ly/Q02G2kl60 #IVD #Diagnostics #RapidTesting #PointofCare #HealthcareInnovation #PublicHealth #ClinicalResearch #CRO #FDAAuthorization #HCV #Cepheid #DCNDx

We are proud to share that the FDA has granted De Novo marketing authorization with CLIA Waiver for the Cepheid Xpert HCV test, the first capillary whole blood (fingerstick) point-of-care RNA test for Hepatitis C Virus (HCV). This test, supported by DCN Dx’s clinical research, simplifies the HCV testing process, delivering results within one hour and enabling same-visit diagnosis and treatment initiation. The NIH-FDA Independent Test Assessment Program (ITAP) played a pivotal role in this achievement. Our collaboration with NIH-FDA ITAP, Cepheid, and participating clinical sites was crucial in ensuring the test’s timely evaluation and authorization. Kudos to Cepheid on this milestone! We are honored to have contributed to the clinical research that supported the NIH-FDA ITAP program and the successful De Novo authorization of the Xpert HCV test. To learn more, read the release here: https://hubs.ly/Q02G2rlP0 #IVD #Diagnostics #RapidTesting #PointofCare #HealthcareInnovation #PublicHealth #ClinicalResearch #CRO #FDAAuthorization #HCV #Cepheid #DCNDx

We are proud to share that the FDA has granted De Novo marketing authorization with CLIA Waiver for the Cepheid Xpert HCV test, the first capillary whole blood (fingerstick) point-of-care RNA test for Hepatitis C Virus (HCV). This test, supported by DCN Dx’s clinical research, simplifies the HCV testing process, delivering results within one hour and enabling same-visit diagnosis and treatment initiation. The NIH-FDA Independent Test Assessment Program (ITAP) played a pivotal role in this achievement. Our collaboration with NIH-FDA ITAP, Cepheid, and participating clinical sites was crucial in ensuring the test’s timely evaluation and authorization. Kudos to Cepheid on this milestone! We are honored to have contributed to the clinical research that supported the NIH-FDA ITAP program and the successful De Novo authorization of the Xpert HCV test. To learn more, read the release here: https://hubs.ly/Q02G2NBs0 #IVD #Diagnostics #RapidTesting #PointofCare #HealthcareInnovation #PublicHealth #ClinicalResearch #CRO #FDAAuthorization #HCV #Cepheid #DCNDx

We are proud to share that the FDA has granted De Novo marketing authorization with CLIA Waiver for the Cepheid Xpert HCV test, the first capillary whole blood (fingerstick) point-of-care RNA test for Hepatitis C Virus (HCV). This test, supported by DCN Dx’s clinical research, simplifies the HCV testing process, delivering results within one hour and enabling same-visit diagnosis and treatment initiation. The NIH-FDA Independent Test Assessment Program (ITAP) played a pivotal role in this achievement. Our collaboration with NIH-FDA ITAP, Cepheid, and participating clinical sites was crucial in ensuring the test’s timely evaluation and authorization. Kudos to Cepheid on this milestone! We are honored to have contributed to the clinical research that supported the NIH-FDA ITAP program and the successful De Novo authorization of the Xpert HCV test. To learn more, read the release here: https://hubs.ly/Q02G2pNG0 #IVD #Diagnostics #RapidTesting #PointofCare #HealthcareInnovation #PublicHealth #ClinicalResearch #CRO #FDAAuthorization #HCV #Cepheid #DCNDx

For those interested in a deep dive in what it takes to deliver an big idea from a research laboratory to the hands of patients, I strongly encourage you to read this fascinating story about Tzield, the first ever disease-modifying therapy to delay clinical (Insulin dependent) T1D. This is the first FDA approved drug EVER that addresses the cause of T1D, not just the symptoms. What an awesome story, over 38 years in the making.... #JDRF #Breakthoughs #T1D https://lnkd.in/gUA6Ti3H

💊Pill VV116, an antiviral medication for the treatment of Covid-19 manufactured by Junshi Biosciences, revealed positive data from their Phase III trial! The trial is a double-blinded, randomized trial with over 1000 patients enrolled. VV116 showed a reduction in days for symptom resolution after infection with almost a 2 day decrease compared to placebo patients. The drug is already approved for marketing in China since January and results showed fewer safety concerns when compared to Paxlovid. VV116 will be beneficial for the treatment and further understanding of Covid-19! https://hubs.li/Q02brNBQ0

In light of #rarediseaseday, I wanted to share an article I wrote about the different ways that patients are accessing necessary treatments. For many rare disease patients an approval does not necessary correlate to access. I spoke to experts about the challenges some rare disease patients face and the different approaches some patients are taking to get necessary treatment. To learn more click the link below. #raredisease #patientaccess #pharmaceuticaltechnology #pharma https://lnkd.in/ewit5bxb

RNA interference effectively suppresses RAGE without adverse effects on the lungs of #asthma patients. This breakthrough study highlights the promising impact of RNA interference in asthma treatment. #AsthmaResearch #RNAInterference