DxS Expand Their Portfolio Of Cancer Mutation Products, With The Launch Of A PI3K Mutation Detection Kit

Main Category: Cancer / Oncology
Also Included In: Breast Cancer;  Medical Devices / Diagnostics
Article Date: 10 Nov 2008 - 4:00 PDT

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DxS, a personalised medicine company and market leaders in the provision of companion diagnostics are pleased to announce the addition of a PI3K Mutation Detection Kit to their portfolio of oncogene mutation products.

PI3K is a biomarker assessed during the evaluation of the tyrosine kinase inhibitors targeting the EGFR pathway. The PI3K-AKT pathway is activated in a variety of tumour types resulting in cell growth and proliferation. DxS' PI3K Mutation Test Kit will detect 4 somatic mutations in exons 9 and 20 of the PIK3CA oncogene which are frequently found in a number of different cancers including up to 40% of breast cancer. The presence of these mutations may influence the response to targeted therapies and prognosis, and screening for PI3K mutations using the DxS kit will aid researchers in determining these correlations.

Using their real-time PCR technology Scorpions®, DxS has developed a highly sensitive and selective test to detect mutations at very low levels that can be performed in less than three hours. The assay is able to detect 1% of mutation in a background of wild-type genomic DNA and its unrivalled selectivity means that it highlights mutations often missed by sequencing methods.

Dr Stephen Little, CEO of DxS said: "Our product range has always been shaped by the needs of the pharmaceutical industry, and we are constantly building on the success of our current kits with an expanding pipeline of novel assays. This latest addition furthers our collection of Mutation Detection Kits and will help in the continued progression of personalised medicine in oncology."

The launch of the PI3K Mutation Detection Kit builds on DxS' continued development and expansion in 2008 which has so far seen a licence agreement with the Wellcome Trust in September, the Australian launch of TheraScreen: K-RAS kit in June, as well as DxS' exclusive global distribution agreement with Roche earlier this year.

DxS is a personalised medicine company providing products, technology and services to the healthcare industry to enable the delivery of safe and effective medicines. The Company has also established itself as a leader in the provision of companion diagnostics to the personalised cancer medicine market.

DxS has a range of products including cancer mutation assays and kits, molecular diagnostic technologies and genetic analysis services. Its TheraScreen® range of CE-marked kits can identify genetic tumour mutations affecting how patients respond to cancer therapies, enabling doctors and drug companies to provide the treatment most likely to benefit patients. DxS produce two clinical diagnostic kits, K-RAS, and EGFR-29. The K-RAS assay has been chosen as the companion diagnostic for Amgen's colorectal cancer therapy Vectibix®. DxS has an exclusive global distribution agreement with Roche Molecular Systems for the distribution of the TheraScreen K-RAS Mutation Test and TheraScreen EGFR 29 Mutation Test.

DxS' real-time PCR technology, Scorpions® utilises its speed and sensitivity and underpins the products and services. This class-leading technology is also available for licence to diagnostic companies, for research, applied and other applications.

DxS is a private, venture capital backed company operating from Manchester's Technology Quarter within the UK.

For further information please visit http://www.dxsdiagnostics.com.

References

1. Mattia Barbareschi, Fiamma Buttitta, Lara Felicioni, Sabrina Cotrupi, Fabio Barassi, Maela Del Grammastro, Antonella Ferro, Paolo Dalla Palma, Enzo Galligioni and Antonio Marchetti. (2007). Different Prognostic Roles of Mutations in the Helical and Kinase Domains of the PIK3CA Gene in Breast Carcinomas. Clin Cancer Res 13(20): p6064-6069.

2. Douglas A Levine, Faina Bogomolniy, Cindy J Yee, Alex Lash, Richard R Barakat, Patrick I Borgen and Jeff Boyd. (2005). Frequent Mutation of the PIK3CA Gene in Ovarian and Breast Cancers. Clin Cancer Res 11(8): p2875-2878.

3. Gizeh Perez-Tenorio, Liza Alkhori, Birgit Olsson, Marie Ahnstrom Waltersson, Bo Nordenskjold, Lars Erik Rutqvist, Lambert Skoog and Olle Stal. (2007). PIK3CA Mutations and PTEN Loss Correlate with Similar Prognostic Factors and Are Not Mutually Exclusive in Breast Cancer. Clin Cancer Res 12(12): p3577-3584.

4. Yardena Samuels, Luis A Diaz Jr, Oleg Schmidt-Kittler, Jordan M Cummins, Laura DeLong, Ian Cheong, Carlo Rago, David L Huso, Christoph Lengauer, Kenneth W Kinzler, Bert Vogelstein and Victor E Velculescu. (2005). Mutant PIK3CA promotes cell growth and invasion of human cancer cells. Cancer Cell 7:p561-573.

5. Guojun Wu, Mingzhao Xing, Elizabeth Mambo, Xin Huang, Junwei Liu, Zhongmin Guo, Aditi Chatterjee, David Goldenberg, Suzanne M Gollin, Saraswati Sukumar, Barry Trink and David Sidransky. (2005). Somatic mutation and gain of copy number of PIK3CA in human breast cancer. Breast Cancer Research 7(5).

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