NewGene develops breakthrough test for hereditary breast cancer

A new breakthrough test for hereditary breast cancer developed by UK-based NewGene could see thousands of women being diagnosed with the genetic condition in around half the usual time and at around half the cost of conventional test methods.

The availability of the test in France and Germany is the latest move from the molecular diagnostic company that is delivering high quality, cost effective and fast turnaround clinical genetics testing services by harnessing the power of new medical sequencing and genotyping technologies.

Jointly owned by Newcastle Hospitals NHS Foundation Trust and Newcastle University, NewGene has pioneered the development, validation and commercial availability of a range of specialist clinical genetic tests using advanced gene sequencing platforms that have traditionally been restricted to medical research applications.

Innovative use of technology that includes the Roche 454 GS-FLX Next Generation Sequencer and the Sequenom MALDI-TOF Mass Spectrometer, has enabled NewGene to introduce a range of clinically important tests that are available to healthcare organisations throughout Europe. As well as the new hereditary breast cancer test these also include a range of stratified medicine tumour marker tests for metastatic colon and lung cancers and haemato-oncology tests.

The latest advanced gene sequencing process developed by NewGene identifies all mutations in the coding regions of two genes associated with inherited breast cancer - BRCA1 and BRCA2 - and not only significantly reduces the amount of time that women have to wait for their results but will cost much less to provide.

The breakthrough follows two years of test development work which has combined the sequencing and genotyping technologies, NewGene's clinical expertise and specially developed data analysis software that enables high volume testing of gene sequences to be undertaken at a level not previously possible.

The onset of hereditary breast cancer is usually at a much earlier age than other cases and the most frequent cause is a gene mutation which can be passed from one generation to the next.

The new breast cancer test has already been successfully used in gene testing work carried out for the Northern Genetics Service‚ an NHS clinical genetics service serving patients in England. As a result, the availability of the new test to European healthcare providers will mean the earlier identification of family members at risk of developing breast cancer.

Dr. Michael Wright, Assistant Medical Director of Newcastle Hospitals NHS Foundation Trust and a Director of NewGene said: "This test opens the way for healthcare organisations to significantly improve the speed and quality of the service that they provide to patients and their families whilst halving the cost per test at the same time.

"Our close partnership with NHS organisations means we have access to clinical patient samples which have enabled us to validate our testing and ensure identification of all mutations."