Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573073
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Liquid biopsy plays a pivotal role in cancer therapeutics encompassing critical applications such as early cancer detection disease progression monitoring and tailored treatment plan formulation heralded as a pivotal avenue for the future of cancer management Established in 2015 LifeOS Genomics Co Ltd stands among the select few domestic enterprises pioneering the autonomous development of digital Polymerase Chain Reaction PCR technology The companys automated nucleic acid amplification quantitative analysis platform QLoci md1000 Analyzer demonstrates outstanding proficiency featuring sixty thousand wells per PCR chip Integrating digital PCR technology it elevates analytical sensitivity beyond 01 LifeOS commissioned the Core Laboratory of Pharmacogenomics at the National Taiwan University to conduct clinical validation assessments for their developed EGFR T790M Mutation Detection Assay Kit This assay kit secured official registration by the Taiwan Food and Drug Administration TFDA as a Laboratory Developed Test LDT in 2023 permitting the issuance of medical testing reports
This initiative aims to validate the detection capabilities of LifeOS Genomics Co Ltds EGFR T790M Mutation Detection Assay Kit prospectively clinically in clinical lung cancer patient plasma samples addressing unmet clinical needs for early cancer detection disease progression monitoring and aiding physicians in diagnosis and pharmacotherapy
This initiative aims to validate the detection capabilities of LifeOS Genomics Co Ltds EGFR T790M Mutation Detection Assay Kit prospectively clinically in clinical lung cancer patient plasma samples addressing unmet clinical needs for early cancer detection disease progression monitoring and aiding physicians in diagnosis and pharmacotherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None