HCV Clinical Trials Services

Rich pipelines of innovative HCV therapeutics are currently in development and new agents are forthcoming. Harness the power of Virco’s HCV platform demonstrating clinical and analytical sensitivity for:

• Genotyping and subtyping of the HCV virus using established, extensively-referenced methods
• Monitoring emergence of drug resistant HCV mutations
• Characterizing emergence of minority species
• Measuring the impact of  mutations on drug sensitivity
• Covers all aspects of clinical development from phase I to market approval and beyond

Virco provides a package of solutions to characterize the different HCV viral subtypes during product testing. Call us today or click here for more information.

High Quality/High Throughput

HCV resistance or virologic data is required by regulatory agencies for evaluation of HCV drug candidates. Trust Virco for sequencing assays that characterize mutations which may lead to resistance following exposure to new therapies.

Since 2008, Virco has analyzed over 10,000 HCV genotype sequences, which has led to considerable experience and insight on the types, subtypes and sites where mutations occur on the HCV genome. Capitalize on our expertise to provide the required regulatory information needed for HCV resistance characterization using a variety of Virco assays specifically designed to support high quality, HCV high-throughput requirements.

Virco 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^[1], Virco 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, routineHCV genotyping or subtyping assays may miss .  

Virco’s assay is:

• Sequenced based
• An accurate discrimination between the virus 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.

HCV sequencing (*)

Clinical studies characterizing the efficacy of novel, direct antiviral agents (DAA) have high quality and high throughput requirements. Virco has developed a proprietary platform addressing the HCV sequencing needs for these types of trials.

• Virco’s high throughput sequencing assays cover the complete coding region NS3/4A; NS4B/5A and NS5B
• HCV assays use subtype specific primers  developed and validated from a large panel of clinical samples, subtypes: 1a, 1b, 2a, 2, 2b, 2, 3a, 4a and 4d

• Rapid turnaround time
  • 14 business days for the standard TAT (from date of sample receipt)
  • 7 business days for subtyping from 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 (*)

Virco 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 (*)

Virco offers replicon-based HCV phenotyping assays. For more information on HCV phenotyping, please contact us .

Quality

Virco’s HCV clinical services are compliant with 21 CFR 809 .10 (c) (2) (i) and validated for research use only* (RUO).   Virco’s laboratory, employees, reagent selections and equipment comply and are certified to high quality standards:

• Laboratory: CAP / CLIA / NY State certified
• Laboratory staff: IERF certified, competent, ongoing professional training encouraged
• Reagents: Incoming reagents quality control checked for critical items
• Equipment: Calibrated & validated
• Data reporting systems: All data reporting systems are 21 CFR 11 compliant