Clinical trial designed for HCV patients
High Quality/High Throughput
HCV resistance or virologic data is required by regulatory agencies for evaluation of HCV drug candidates. Janssen Diagnostics provides sequencing assays that characterize mutations which may lead to resistance following exposure to new therapies.
Janssen Diagnostics offers solutions in:
- HCV genotyping and subtyping
- HCV sequencing
- HCV deep sequencing
- HCV phenotyping
HCV Genotyping and Subtyping
Because routine HCV genotyping and subtyping assays are not always able to provide reliable subtype information, Janssen Diagnostics has developed a state-of-the-art sequence-based assay covering genotypes 1-6 to determine the subtype of the virus for patients enrolling in direct-acting antiviral clinical trials. These tests are used to determine HCV subtypes that commercial, routine HCV genotyping or subtyping assays may miss .
Janssen Diagnostics assay is:
- Sequenced based
- An accurate discrimination between the viral subtypes and provides high clinical sensitivity and assay sensitivity among 603 geographically diverse samples obtained from chronically infected HCV patients
- Described in the Type V Drug Master File submitted to FDA. It is a reference source for information, which supports and facilitates data filing in the United States.
Clinical studies characterizing the efficacy of novel, direct antiviral agents (DAA) have high quality and high throughput requirements. Janssen Diagnostics has developed a proprietary platform addressing the HCV sequencing needs for these types of trials.
- Janssen Diagnostics’ high throughput sequencing assays cover the complete coding region NS3/4A; NS4B/5A and NS5B
- HCV assays use subtype specific primers developed from a large panel of clinical samples, subtypes: 1a, 1b, 2a, 2, 2b, 2, 3a, 4a and 4d
- Rapid turnaround time as quick as 14 business days for sequencing from date of sample receipt
- 7 business days for subtyping from date of sample receipt
- Separate mutation reports based on alignment against subtype-specific reference sequence and H77
- Described in the Type V Drug Master File submitted to the FDA. It is a reference source for information which supports and facilitates data filing in the United States.
HCV deep sequencing
Janssen Diagnostics delivers tangible results and true expertise with 454 deep sequence testing for HCV clinical trials. For additional information on deep sequencing, please contact us
HCV Phenotype Testing
Janssen Diagnostics offers replicon-based HCV phenotyping assays. For more information on HCV phenotyping, please contact us .
How do you randomize the patients in a clinical trial?
a computer does the randomizing in order to bypass human bias. Many, if not all of the people involved in the investigation will continue to be "blinded" to what the patient is actually receiving.