Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...

Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

Flow cytometry assay validation requires different analytical approaches in preclinical and clinical settings. A fit-for-purpose (FFP) strategy allows researchers to customize the validation to ...

Cancer biomarkers span a broad biological spectrum, including proteins, metabolites, and nucleic acids detectable in samples such as tissue biopsies and blood. 1 At the beginning of a biomarker ...

Leading Diagnostic Healthcare Company Also Announces Over 50 Initial Clinic Commitments for Its Full Diagnostic Assay Platform The Company had previously announced the commencement of commercial ...

Dr. Stephen will cover the process of developing and manufacturing reliable Luminex biomarker assays, as well as using those assays to test samples. She will examine the development of Ampersand ...

Assays to measure homologous recombination deficiency (HRD) in ovarian cancer vary widely, underscoring the need for standardization, since inconsistent assay results can influence treatment decisions ...

Figure 8: Major analytical performance measurements of the NeXT Personal assay. “NeXT Personal uses whole genome sequencing of tumor and matched normal samples combined with advanced analytics to ...