About us

Elucigene assays have provided cost-effective solutions to clinical testing since 1994 and continue to be the first choice of assays in many laboratories around the world. If you are looking for quality and innovative products manufactured by the experts in genetic assay design and development, our responsive support services will assist the implementation of Elucigene in your laboratory.

Product information brochures are available to view or download, and contact details are provided should you require further information. On these pages youâll also find all the information you need to perform your genetic testing using Elucigene products. A simple registration procedure gives access to all the instructions for use, guides to analysis and software template downloads to ensure you achieve maximum productivity from your Elucigene workload.

Elucigene products are designed and developed to deliver high information content but with unbeatable simplicity of use. Genetic analysis is a complex process. Our ethos is to simplify the process and make testing quicker and easier. Thatâs why we develop highly multiplexed assays that provide maximum clinically relevant content just by adding DNA.

At Elucigene Diagnostics we are committed to responding to current and future clinical testing needs through our research and development programs, manufacturing innovative products with the simple aim of delivering clarity without complexity.

1989

ICI Diagnostics
ARMS® technology invented by ICI diagnostics.

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ARMS (or Amplification Refractory Mutation System) is a modified method of the PCR (Polymerase Chain Reaction) to determine single base changes or small deletions/insertions in DNA sequence. ARMS was patented by ICI in 1989 under European patent No.0332435 and is the underlying technology used in the development of Elucigene assays. Although the ARMS patent expired in 2009 in most territories Elucigene products continue to be developed incorporating this powerful and accurate method of DNA analysis.

Original ARMS publication –

Newton CR, Summers C, Heptinstall LE, Lynch JR, Finniear RS, Ogilvie D, Smith JC, Markham AF. Genetic analysis in cystic fibrosis using the amplification refractory mutation system (ARMS): the J3.11 MspI polymorphism. J Med Genet. 1991 Apr;28(4):248-51.

1992

ICI Diagnostics
First ARMS singleplexes developed for mutation detection in the cystic fibrosis (CF) gene.

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The gene responsible for the debilitating disease cystic fibrosis was identified, characterised and sequenced in 1989. The gene was named cystic fibrosis transmembrane conductance regulator (CFTR for short). The identification of the gene and its DNA sequence opened up possibility of targeted assays for detection of mutations responsible for cystic fibrosis disease status. Since CF is one of the most common inherited genetic diseases in Caucasians it presented an ideal target for the development of diagnostics assays for clinical use.

Scientists at ICI Diagnostics applied the ARMS technology to the newly discovered CFTR gene to simply and rapidly identify the presence or absence of known CF disease causing mutations.

Three simultaneous publications announced the discovery of the CFTR gene:

Rommens JM, Iannuzzi MC, Kerem B, Drumm ML, Melmer G, Dean M, Rozmahel R, Cole JL, Kennedy D, Hidaka N, et al. Identification of the cystic fibrosis gene: chromosome walking and jumping. Science. 1989 Sep 8;245(4922):1059–1065

Riordan JR, Rommens JM, Kerem B, Alon N, Rozmahel R, Grzelczak Z, Zielenski J, Lok S, Plavsic N, Chou JL, et al. Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science. 1989 Sep 8;245(4922):1066–1073.

Kerem B, Rommens JM, Buchanan JA, Markiewicz D, Cox TK, Chakravarti A, Buchwald M, Tsui LC. Identification of the cystic fibrosis gene: genetic analysis. Science. 1989 Sep 8;245(4922):1073–1080

1994

Zeneca Diagnostics (formerly ICI Diagnostics)
Elucigene CF4, the first Elucigene product is commercialised.

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Scientists at Zeneca Diagnostics collaborated with St Mary’s Children’s Hospital, Manchester to develop and validate a kit that identified four disease causing mutations in the CFTR gene. The Elucigene CF4 kit was CE marked for in vitro diagnostic use and supplied as a 2 tube assay, one tube detecting wild type sequence and the other tube detecting mutant sequence.

Ferrie RM, Schwarz MJ, Robertson NH, Vaudin S, Super M, Malone G, Little S. Development, multiplexing, and application of ARMS tests for common mutations in the CFTR gene. Am J Hum Genet. 1992 Aug;51(2):251-62

1997

AstraZeneca Diagnostics
French regulatory accreditation of Elucigene products.

2001

Orchid BioSciences acquire the Diagnostics business from AstraZeneca.

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February 2001- Orchid acquire the Diagnostics business from AstraZeneca, which include the Cellmark identity testing business and the Elucigene business. Orchid BioSciences Inc. are a NASDAQ listed life sciences company based in Princeton, New Jersey, US. with other operations and facilities in Texas,, California and Connecticut.

2001

Orchid BioSciences
Elucigene products announced as the exclusive supplier to the national French cystic fibrosis newborn screening program.

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The Association Francaise pour le Depistage et la Prevention des Handicaps de L’Enfant (AFDPHE) and Orchid Biosciences finalise an agreement to ensure a secure supply of cystic fibrosis mutation detection kits to the newly introduced neo-natal screening program. The screening of CF will be implemented in all regions of France by the end of 2002 for all newborns (about 800,000 yearly). The screening is a two stage program, immuno-reactive trypsin (IRT) followed by genetic testing. Elucigene CF20 kits from Orchid BioSciences will be exclusively used in nine regional laboratories across France to provide the genetic testing capability. Orchid BioSciences will, in collaboration with AFDPHE, develop an expanded panel of CF mutations more commonly found in the French population for introduction into the neo-natal screening program.

Note: Elucigene Diagnostics continues to exclusively supply Elucigene products to the French newborn screening program.

2002

Orchid BioSciences
Elucigene CF29 is launched. Elucigene CF29 is the first commercialised IVD kit that meets the new CF screening requirements in the United States.

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In 2001 recommendations and guidelines for cystic fibrosis carrier screening were introduced. The American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynaecologists (ACOG) in consultation with the National Institutes of Health (NIH) identified a ‘pan-ethnic’ panel of 25 cystic fibrosis disease causing mutations for routine screening of the US population. The recommendation is to provide couple based testing where both partners are tested simultaneously or sequential testing where one partner is tested first (usually the woman) and if positive the other partner is tested. Elucigene CF29 detects all 25 mutations identified in the US recommendation and is made available to CLIA approved laboratories as an Analyte Specific Reagent for implementation into laboratories cystic fibrosis screening programs.

Technical Standards and Guidelines for CFTR Mutation Testing

Standards and Guidelines for Clinical Genetics Laboratories 2002 Approved by the Board of Directors of the American College of Medical Genetics  October 26, 2002. Genetics in Medicine 2002;3 (5).

Reviewed and Revised: 2005 by the Molecular Subcommittee of the Laboratory Quality Assurance Committee

Note: Elucigene products have not been cleared by the FDA and all were withdrawn from the US market in 2010.

2004

Tepnel Life Sciences acquires Elucigene from Orchid BioSciences.

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Tepnel Life Sciences Ltd, a UK registered company with its headquarters in Manchester, acquires the ‘diagnostics’ businesses from Orchid BioSciences. The acquired businesses are the Elucigene and Lifecodes operations. LIFECODES sells molecular and antibody-based assays in the markets of transplant diagnostics, specialty coagulation and transfusion medicine and has facilities in Stanford, Connecticut. Elucigene has its facilities in Abingdon, UK. The acquired businesses will be known as Tepnel Diagnostics.

2005

Tepnel Diagnostics announces the next generation of Elucigene assays utilising Fluorescent ARMS.

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Although the existing ELUCIGENE CF29 product addresses all the recommendations for CF testing, it is relatively low throughput due to its agarose gel format. Laboratories currently recognise the significant and increasing demand for CF testing and they have preferences for automatable high throughput assays when choosing their CF testing method of choice. As the volume of CF testing continues to increase the number of laboratories with high throughput needs increases.

The Fluorescent ARMS CF product (Elucigene CF-HT, i.e. CF – High throughput) provides laboratories with a high throughput, semi- automated cystic fibrosis assay. The product operate is used on an automated capillary based DNA Sequencer such as a ABI3100. Full genotyping of wild-type and mutant alleles is provided in a two tube assay with automated analysis and reporting through ABI’s GeneMapper software. Fluorescent ARMS technology further expands the scope for increased levels of multiplexing and simplification of genetic testing assays for the user.

2006

Tepnel Diagnostics
The Elucigene QST*R® range of products are released for prenatal testing for common chromosome abnormalities.

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The ELUCIGENE QST*R is a DNA-based assay for the rapid detection during pregnancy of common chromosome abnormalities, including Down syndrome, Edwards syndrome and Patau syndrome. The diagnostic test was developed in collaboration with Guy’s and St Thomas’ NHS Trust Hospital in London. It is a highly sensitive and rapid test that can provide results within 4 hours, compared with 12-14 days needed for current standard tests. Elucigene QST*R utilises QF-PCR (Quantitative Fluorescent – Polymerase Chain Reaction) technology for the rapid and sensitive detection of genetic markers.

Mansfield E S.. Diagnosis of Down syndrome and other aneuploidies using quantitative polymerase chain reaction and small tandem repeat polymorphisms. Human Molecular Genetics 1993 2(1): 43-50.

Mann K, Fox SP, Abbs SJ, Yau SC, Scriven PN, Docherty Z, Mackie Ogilvie C. Development and implementation of a new rapid aneuploidy diagnostic service within the UK National Health Service and implications for the future of prenatal diagnosis. The Lancet 2001 358 (9287):1057-1061

2009

Tepnel Diagnostics
Tepnal releases Elucigene CF-EU1 for increased sensitivity of detection of cystic fibrosis mutations in European populations.

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The Elucigene CF-EU1 kit offers significant advantages over existing CF testing kits both in terms of informativity and ease of use. The kit has been specifically designed for the analysis of European populations. The assay is a simple PCR with no additions other than sample DNA and no post-PCR manipulation required. The assay provides maximum flexibility for testing laboratories. It can be run either as a mutation screening test (using tube A alone) or as a full genotyping assay. The poly T tract is labelled with a separate dye that can be selected on or off. Uniquely, the kit also accurately determines the number of TG repeats adjacent to the poly T. This has been shown to be associated with increased pathogenicity in individuals who have a 5T allele and who carry a CF mutation.

Tepnel has collaborated with SoftGenetics LLC to develop a custom application in their GeneMarker genetic analysis software that presents the results from the assay in a clear, concise easy to read one page format.

2009

Gen-Probe Inc acquires Tepnel Life Sciences.

2010

Gen-Probe Life Sciences
Elucigene CF-EU2 released, an expansion of the CF-EU1 product, Elucigene CF-EU2 identifies 50 CFRT mutations.

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The Elucigene CF-EU2v1 kit has been specifically developed and approved for in vitro diagnostic testing within Europe. The Elucigene CF-EU2v1 assay identifies 50 of the most frequently observed CFTR gene mutations within populations of European origin.

Key Benefits of using Elucigene CF-EU2v1 Kits:

Key Benefits of using Elucigene CF-EU2v1 Kits:

• Developed specifically for testing European populations

• The only commercially available product that quantifies intron 8 TG repeat variance

• Poly T analysis can be switched on or off as required

• Detects wildtype and mutant alleles (i.e. full genotyping)

• Validated for use on Applied Biosystems’ 3100/3130/3500 Genetic Analyzers

• Results can be analysed using GeneMapper or GeneMarker software

• Customized GeneMarker application for simple patient analysis and reporting

2012

Hologic Inc acquire Gen-Probe Inc.

2013

The Elucigene business is acquired from Hologic.
Elucigene Diagnostics created.

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With 53 years experience between them in the Diagnostics industry and 26 years specifically involved with the operation and management of the Elucigene business, Mike Webb and Scott Higgins successfully acquire the Elucigene business. Delta Diagnostics (UK) Ltd trading as Elucigene Diagnostics with development and manufacturing facilities in Manchester plan to expand the Elucigene product offerings to meet the needs of the clinical testing laboratories. Elucigene Diagnostics develop, manufacture and supply highly informative but yet simple to use assays to diagnose complex genetic disease backed up by unsurpassed customer service and satisfaction.