Qiagen is about to introduce a test to determine mutations of the K-ras gene.
The K-ras gene is mutated in between 35 and 45 per cent of metastatic colorectal cancer (CRC) patients.
Studies have shown that K-ras testing can better define which CRC patients will benefit from treatment with epidermal growth factor receptors (EGFR) inhibiting monoclonal antibodies, such as Amgen's Vectibix (panitumumab) and Imclone/Bristol-Myers Squibb's Erbitux (cetuximab).
Qiagen's 'PyroMark Q24 K-ras Assay-Kit' is CE-marked for use in second-line treatment of metastatic CRC together with Erbitux or Vectibix and will be available near the beginning of 2009.
Qiagen also intends to launch this assay for in vitro diagnostic use in the US.
Qiagen's 'PyroMark Q24 K-ras Assay-Kit' can detect all major and minor known mutations in the K-ras codons 12, 13 and 61 and also allows the discovery of new mutations.
This is the first molecular assay Qiagen has introduced based on Pyrosequencing, a fundamental technology for short-length, high resolution sequence analysis and quantification.
Qiagen acquired the technology and the associated business from Biotage in October 2008.
Peer Schatz, chief executive officer of Qiagen, said: 'Unlike other technologies routinely used in molecular diagnostics (such as PCR), Pyrosequencing reads the actual target sequence.
'While PCR can only detect known sequences, Pyrosequencing can detect all known and unknown genetic variations in all DNA target regions in which mutations occur.' The market for K-ras testing has grown in the past few months.
Recent studies, including a large multinational prospective study conducted by The University of Leuven University in Belgium, suggested the K-ras mutation status is a prognostic biomarker that predicts the outcome of EGFR therapies.
In this study, approximately 40 per cent of all CRC-patients had mutated K-ras genes.
The trial data indicated that such patients will not benefit from, and in some cases will even experience negative reactions to EGFR antibodies.
Patients without specific mutations are likely to benefit from this drug treatment.
In response to these studies, European regulators adopted the indication for Vectibix (panitumumab) to include only patients whose tumours carry the unmutated K-ras gene.
Earlier this month, the US National Comprehensive Cancer Network (NCCN) issued guidelines for treatment of CRC, which recommended that only patients with tumours characterised by the unmutated K-ras gene should be treated with EGFR drugs.
The organisation recommended oncologists should generally determine the K-ras gene status of all patients diagnosed with CRC prior to any treatment.
For the future, experts also expect the inclusion of molecular diagnostic tests for K-ras testing as companion tests for EGFR treatment of other cancers, such as lung adenocarcinomas or thyroid cancer.
Schatz added: 'Personalised medicine will without doubt further shape the future of healthcare.
'It enables physicians to customise therapies for effectiveness and efficiency, it greatly reduces healthcare costs and, most importantly, it can contribute to the avoidance of unnecessary or even harmful treatments for patients suffering from serious diseases.'