Molecular Diagnostic Technologies

Scorpions™ is a homogeneous or closed-tube platform for PCR analysis. It is ideal for all diagnostic applications which require rapid and reliable PCR detection such as viral load testing, RNA profiling, pharmacogenomics and environmental analysis. Scorpions is a class leading technology with significant technical benefits over competing technologies. Product development programmes utilising DxS' experience helps companies expedite the launch of next generation molecular diagnostics. Significantly Scorpions also enjoys a strong independent Intellectual Property position and is available for license from DxS Ltd.

Performance

	Sensitivity - the limit of detection is a few molecules even in the presence of very high levels of background DNA.
	Specificity - both the Scorpion primer region and probe region can be made sequence specific. This gives unparalleled discrimination allowing the detection of single nucleotide changes even in admixtures where the alternative sequence is in vast excess.
	Speed - Scorpions signal generation is widely recognised as the fastest in its class. This means that the technology can support very rapid PCR allowing detection in less than ten minutes.
	Difficult Sequences - the intra-molecular signal generation mechanism means that Scorpions are particularly good at detecting targets in regions of high G+C content or secondary structure.

Intellectual Property

Scorpions already has worldwide patent coverage with granted patents in USA and Europe and protection in Japan. This is in contrast to other detection systems which are not currently protected in Europe.

Licensing

Scorpions is owned by DxS Ltd. As an independent biotechnology company we are able to tailor a licensing agreement to meet the needs of our clients and if required can provide support ranging from technology transfer all the way through to diagnostic design and development.

Scorpions

The Scorpions Reaction

Scorpions are bi-functional molecules containing a PCR primer covalently linked to a probe. The fluorophore in the probe interacts with a quencher which reduces fluorescence. During a PCR reaction the fluorophore and quencher are separated which leads to an increase in light output from the reaction tube. There are two formats for Scorpions. The diagram below shows the bi-molecular Scorpion format. The alternative is known as the unimolecular format in which an integral stem loop sequence is used to bring the quencher close to the fluorophore

Elements of a Scorpions Primer

Step 1 - The Scorpions primer is extended on target DNA

Step 2 - The extended primer is heat denatured and the quencher disassociates

Step 3 - As it cools the extended Scorpion undergoes an internal rearrangement and begins to fluoresce in a target specific manner. Unextended primer is quenched

Scorpions are described more fully in Whitcombe, D., Theaker J., Guy, S.P., Brown, T., Little, S. (1999) - Detection of PCR products using self-probing amplicons and flourescence. Nature Biotech 17, 804-807. Which can be downloaded from the DxS website on the bibliography page

View Animation of Scorpions Reaction.

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Scorpions Performance Data

For further technical information about Scorpions technology, view Scorpions Performance Data.

Product Development

A diagnostic product development programme is available to provide both consultancy and practical support to companies. Projects of mutually agreed specification are undertaken from proof of concept to a CE marked diagnostic test.
The service draws on our experience of the technology to accelerate partner companies product launch to ensure early access to new markets.

Steps involved in Product Development:

Design and plan

Prototype testing

Assay optimisations

Assay validation (3 batch analysis)
		Technical
		Reproducibility
		Accuracy
		Robustness
		Tolerance

Assay Verification
		In-house comparison to gold standard method using clinical samples
		Beta site testing

Regulatory
		Preparation of Instructions for Use
		Risk Analysis
		Technical File
		Registration within different countries

Launch

If you would like further information or want to discuss a product development proposal please call DxS on +44 161 606 7201 or email info@dxsdiagnostics.com.

Scorpions Licensing

Scorpions technology is available for license from DxS. Existing licensees for diagnostic applications include Ortho Clinical Diagnostics, Minerva Biolabs GmbH and Sangtec Molecular Diagnostics. There are a number of other significant licensees who have either not yet been announced or with whom negotiations are still in progress.

DxS are also able to offer different levels of licensing support. These include:

	Technology Transfer Programme
	Access to Scorpions design software
	Scorpions design service
	GMP reagent manufacture

For further information about Scorpions, suppliers and licence agreements, please contact DxS on +44 (0) 161 606 7201 or email scorpions@dxsgenotyping.com.

Software

DxS uses state-of-the-art software to assist in the design and optimisation of Scorpion- based assays.

Visual OMP from DNA Software Inc of Ann Arbor, MI, enables us to:

	Design well balanced PCR primers
	Select appropriate probe sites based upon (absence of) target folding
	Design effective probes, taking account of all base-pairing/ mis-pairing and the effects of DNA modifications and labels (fluorophores and quenchers)
	Model the likely effectiveness of primers and probes in multiplex reactions, taking account of all competing structures and hybridisations.

We find that design and optimisation of assays are greatly facilitated by this software.

ARMS Technology

DxS have recently added Amplification Refractory Mutation System (ARMS™) to their portfolio of technologies that are available for licence. ARMS is a well established primary method for the detection of SNP's and other genetic variation. ARMS is a simple, reliable and widely used method for the detection of gene mutations and single nucleotide polymorphisms (SNPs).

Feature

Benefit

Applications

Genotyping

	Very reliable mutation detection method allowing detection of all SNPs and indels
	Converts non-specific PCR detection methods such as intercalation, Amplifluor and Lux into genotyping methods

1. Genetic Testing
2. Pharmacogenetics
3. Personalised Medicine
4. Predisposition Testing
5. Research Genotyping

Q-genotyping

	Allows quantitative genotyping when combined with real-time PCR
	Excellent SNP discrimination ability allows detection of genetic variations when only a small proportion of the sample carries the mutation

6. Sample Pooling
7. Viral Genotyping
8. Tumour Analysis
9. Cancer Screening and Early Detection
10. Cancer Monitoring

Haplotyping

	Combination of two ARMS primers allows direct analysis of the phase of associated SNPs
	Identifies whether SNPs are on the same chromosome

11. Haplotyping
12. HLA testing
13. Promoter Analysis

Multiplexing

	Several ARMS primers can be combined into one reaction
	Compatible with micro-array detection

14. Multiplex Genetic Testing
15. High throughput Genotyping

DxS and BTG Plc have signed an exclusive licence agreement with AstraZeneca to further commercialise the company's technology within the diagnostic and research markets. ARMS is available for licence to companies that wish to exploit this powerful and novel technology for products and services that relate to the detection of genetic variation.

For further information about ARMS licencing opportunities, please contact Dr David Whitcombe on +44 (0) 161 606 7209 or email David.Whitcombe@dxsgenotyping.com

ARMS

View press releases about recently signed licence deals

Bibliography

Publications describing the development and applications of Scorpions technology.

View bibliography

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