View
281
Download
1
Category
Preview:
Citation preview
October 2015
HLA Typing with NGS TechnologyMake the Switch
Introduction to OmixonMarcello Scala, Sales Manager EMEA & AP,
Tim Hague, CEO
Empowering clinical labs with technologies to improve patient
outcomes.
Mission Statement
Corporate Statement
Global biotechnology company– Budapest, Headquarters, Software R&D– Cambridge, MA, Operations and Manufacturing
World leader in HLA Typing by NGS– Best in class Assay– Best in class Software
Existing Products– Holotype HLA (Assay + Software)– HLA Twin (Software)– HLA Explore (Software)
Current stage of the company
Two UK SBRI awards $1.2m
Outsourced manufacturing (US based) ISO-13485
Flagship Product Holotype HLA
Existing customers HLA labs and hospitals
CE marked In Vitro Diagnostic
Proprietary HLA Typing software developed in-house
Exclusively in-licensed HLA assay from CHOP
Early Access Program completed in 24 labs, 13 countries
Customer Challenges
High cost per test for high-resolution tests– Cheaper low resolution test are
insufficient for bone marrow transplants
NGS solves all these challenges
Ambiguous results– Intensive interpretation to resolve– Frequently requires retesting with alternative technology
Labour intensive workflows, low throughput
Customer Adoption
Innovators Early Adopters Early Majority
Believe the Data - Holotype HLA
ASHI validation study at CHOP 253 samples
Double blind alpha study 16 samples, 6 labs each
Clinical routine 2000+ clinical samples at CHOP
Product evaluation study
200 samples99.9% accuracy98.4% sensitivity 99.2% reproducibility
Worldwide Early Access Program 2400+ samples, 24 labs
Early Access Program
Holotype HLA NGS is new technology - for the HLA clinic. Demonstrating that the technology works
reproducibly is key – ‘believe the data’. Early Access Program ran from 11/2014 to 6/2015. 24 labs, 13 countries, 2400 samples, 26000 alleles. > 99.7% accuracy and reproducibility.
Product Positioning
Only whole gene NGS product in the world currently in routine clinical practice
Lowest hands-on time of any of the available NGS HLA typing products
Only product reliably scalable for genotyping 240 samples at 5 loci in a single MiSeq run
HLA Twin has the best analysis results of any of the NGS HLA software tools on the market
HLA Twin is the only software providing reliable, complete, contiguous whole gene consensus sequences
HLA Twin is focused on high-throughput, automated genotyping that is ideal for routine and registry typing
Questions
Tim Hague tim.hague@omixon.comPeter Meintjes peter.meintjes@omixon.com
Recommended