Newgene has developed an advanced gene-sequencing process to successfully identify all mutations in the coding regions of two genes associated with inherited breast cancer - BRCA1 and BRCA2.
In the first application of its type, Newgene is using the Roche 454 GS-FLX platform for complete sequencing of all BRCA genes.
The breakthrough follows two years of assay-development work with specially developed data-analysis software to enable high-volume testing of gene sequences to be undertaken at a level not previously possible.
This technology platform represents a much faster and higher capacity DNA sequencing process than is associated with the traditional Sanger technique used for this type of testing, according to the company.
The availability of the advanced test to UK and European healthcare providers will mean the earlier identification of family members at risk of developing breast cancer.
In addition, by reducing the cost of testing, health trusts will be able to extend hereditary breast cancer screening to those who may not currently qualify for gene sequencing.
The Newgene technique makes the identification of mutations less labour intensive, reducing costs and producing faster reporting times.
As a result, the test service can be provided at around half the cost of current NHS breast cancer hereditary testing and has a results turnaround time of as low as four weeks.
The new breast cancer test has already been successfully used in gene-testing work carried out for the Northern Genetics Service, an NHS regional clinical genetics service serving NHS trusts across the North of England.
The new hereditary breast cancer test is the first of a planned series of new molecular diagnostic tests that are due to be introduced by Newgene for other complex genetic conditions and disorders.
