Omixon is gearing up to launch a Multiplex HLA typing product for use on Illumina sequencing platforms. This new product line – OmniType – is expected to be a best-in-class product featuring locus multiplexing and short library preparation. The requirements for its development came both from you in the HLA market and our business development activities across all genomic technologies. We are seeking participants for our Early Access Program (EAP) to test and provide feedback. Is the EAP for you?

OmniType is a product that contains all required reagents and software to analyze all clinically relevant genomic regions of the 11 classical HLA loci. All locus-specific primers will be multiplexed in a single tube for amplicon generation, followed by an innovative library preparation process that allows the pooling of all samples into a single tube during the first step of library preparation. The advantage of this approach is the lowest possible hands-on time, whether automated on a liquid handler or not. The resulting libraries may be sequenced on Illumina’s sequencers, Miseq, NextSeq, Miniseq or iSeq, using the 300-cycle chemistry for a decreased turnaround time. Upon completion of the sequencing, the data will be automatically analyzed using Omixon’s flagship software HLA Twin, that uses the Consensus Genotyping (CG) algorithm already used for genotyping with Holotype HLA.

All participants will need to sign the EAP Agreement and agree to those terms.

 

EAP Timeline

• Invitation
  • Review this guide
  • Review Terms and Conditions of the OmniType EAP Agreement, including:
    • Non-disclosure
    • Publicity, e.g. PR, quotes and testimonials
    • Data sharing (anonymous & anonymized) for peer-reviewed publication
    • Reporting and feedback
• Training
  • We provide training and support to become familiar with the appropriate use of the OmniType kit and software
  • Up to 1 week of a qualified Omixon FAS onsite
• Performance evaluation of the OmniType kit and software
  • You will complete a technical performance evaluation on a minimum 48 of your own samples with known genotypes 
  • Various DNA sources may be tested (eg. buccal swabs, saliva, DNA from compromised patients)
  • Samples with known reference typings, 2nd field resolution minimum for all loci (previous Holotype HLA versions are acceptable)
  • Participant will assess the Omixon software for ease-of-use, computational performance, allele call accuracy, data reporting, and visualization.
• Reporting and Successful Completion
  • Continuous feedback through the process is required
  • Completing questionnaires and other feedback forms is minimal, but required
  • Complete performance evaluation and quality assessment report on the Assay and the Software
  • Provide anonymized Raw Data and Results to Omixon for meta-analysis, re-analysis, and use in a peer-reviewed publication. Omixon will assess assay performance in terms of:
    • Determining concordance/accuracy of genotyping using known samples
    • Demonstrating evenness of coverage depth
    • Demonstrating no allele or locus drop-outs, genomic coverage
    • Comparing the depth of coverage across different indices
    • Demonstrating allele balance
    • Estimating failed sample rate

Benefits to EAP participant

• Early access to assay, first-mover advantage
• 48 samples of free reagents for evaluation provided by Omixon
• Up to 96 samples FOC for additional testing
• Free onsite training with an Omixon FAS
• Future Key Account status
• Ability to influence assay product development roadmap
• Ability to influence software product development roadmap   

Technical and Equipment Requirements

• Owning or having access to an Illumina sequencer (MiSeq preferred)
• A 64-bit computer with a minimum of 24 GB RAM allocated to HLA Twin
• Thermal Cycler: Veriti preferred
• qPCR instrument: Any brand

 

What’s Next?

To register your interest in joining the OmniType Early Access Program, contact your Sales Representative directly or email us at sales@omixon.com