Our Hepatitis C ONETest™ – Soon to be released!

Categories: Next Generation Sequencing Libraries construction, Target Capture of RNA and DNA. Hepatitis C Product Development and Testing, Research Use Only

Applications: Surveillance, Hepatitis testing,

Why did we develop the Hepatitis C ONETest™?

Approximately 10% of Hepatitis C virus (HCV) positive patients fail current front line HCV genotyping tests and are either classified as ‘Indeterminate’ without subtype’ results. Only FUSION GENOMICS’ Hepatitis C ONETest™ specifically targets these patients with both its high sensitivity and the ability to type any known or unknown genotype or subtype.

Infection with HCV is a global epidemic and one of the leading health problems in the world. The WHO estimates that in 2015 approximately 130-150 million people in the world were chronically infected with HCV. An additional 3-4 million people are infected every year!

About 500,000 people die each year from Hepatitis C related liver diseases (1).

Spread of HCV

click on image for a full sized version.

There are over 100 different genotypes of HCV that fall into 11 broad categories. The ideal test would not only be able to detect whether there is RNA in bloodstream, it would also tell us which specific HCV genotype is causing the current infection.

World HCV with genotypes map

A Map from The Center for Disease Analysis showing global distribution and most prevalent genotypes.

A very informative interactive version of the map above.

With the advent of genomic based therapies, HCV genotype determination is more important than ever. The current standard is a 6-11 week regimen for patients with known genotypes. This therapy normally costs about $10,000/ week. For patients whose genotypes cannot be determined, the therapy is extended to 22 weeks, thereby increasing the cost by up to 3 times.

Our Hepatitis C ONETest™ is the first of its kind to allow the re-testing patient population to be diagnosed and genotyped in a single test. It also provides comprehensive genomic information allowing superior and cost effective patient management.

Description Back to Top

How well does the Hepatitis C ONETest™ fill the need?

Current Hepatitis C PCR tests are sub-optimal as they do not give data on existing minority genotypes of Hepatitis C virus in patients, do not cover all sub-types or identify quasi-species and give inadequate data for public health purposes.

FUSION GENOMICS created the Hepatitis C ONETest™ to determine exactly which kind of Hepatitis C virus is present. Capturing the Hepatitis C RNA with our QuantumProbes™ and identifying it with Next Generation Sequencing is a powerful combination that has allowed us to produce an assay that not only rapidly determines whether Hepatitis C is present and active, it also identifies exactly which of the 100’s of strains it is, and does so rapidly and cost effectively.

Using the test FUSION was even able to capture and identify an un-reported Type 3b genome of Hepatitis C, further demonstrating the power of this test and our QuantumProbes™.

The Hepatitis C ONETest™ also gives you access to our FUSIONCloud™ to upload the raw sequence data and receive the results of your data analysis.

Applications Back to Top

The more comprehensive data received from the Hepatitis C ONETest™ holds the promise of more effective surveillance and use of vaccines to help prevent future outbreaks.

Due to high sensitivity of our QuantumProbes™, the assay is expected to be able to detect Hepatitis C at a very early stage of the disease which would be helpful in screening blood donors and could also improve clinical outcomes.

Storage and UsageBack to Top

Store at -20 C. Reactions are conducted on ice.

Testing & DevelopmentBack to Top

The assay is starting external validation and has been designed to give comprehensive genotyping and viral load data.

Who is currently testing our Hepatitis C ONETest™?

The Hepatitis C ONETest™ is being evaluated by the diagnostic division of a major multi-national.

FUSION is also in talks with a major reference lab in British Columbia, Canada for a 2,000 sample retrospective study of Hepatitis C to generate data for regulatory approval.

FAQs & Tips Back to Top

  1. Q: How much sample material do I need?

    A: As much as it takes to yield a minimum of 200ng of high quality RNA for library construction.

  2. Q: How much does the kit cost?
  3. A: Please contact us for pricing.

  4. Q: Are there extra costs for analysing my data?

    A: FUSIONCloud™ web-based data analysis is included at no extra cost in all our Hepatitis C ONETest™ kits.

Protocols & Manual Back to Top

Please contact us for protocols and manuals.

Is the Hepatitis C ONETest™available?

The test is currently available as a Research Use Only product. Please contact us if you would like to obtain this product.