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Roche exclusively distributes DxS K-RAS Cancer Mutation Test

Roche and DxS Ltd. have signed an exclusive distribution agreement for the DxS TheraScreen®: K-RAS Mutation Test. The test is intended, when considered with other clinically relevant factors, to aid doctors in identifying suitable patients likely to benefit from a specific cancer therapy based on their mutation status.


The TheraScreen®: K-RAS Mutation Test was the first clinically validated, CE-Mark certified companion diagnostic for tumor-specific mutations in patients with colorectal cancer. In addition, some drugs used to treat colorectal and other cancers are only indicated for patients who have a non-mutated (or “wild-type”) K-RAS gene. The test detects seven mutations in codons 12 and 13 of the K-RAS oncogene, which are frequently found in many cancer types. These mutations are common in colorectal cancer, pancreatic cancer, lung adenocarcinoma, gall bladder cancer, bile duct cancer and thyroid cancer.

Note: SInce March 23rd 2009 the TheraScreen®: K-RAS Mutation Test is CE-IVD approved for usage on the Roche Diagnostics LightCycler® 480 Instrument II in combination LightCycler® Adapt Software.

Adding Value for Laboratories
CE-mark certification for the TheraScreen®: K-RAS Test ensures labs have access to IVD-compliant, real-time PCR testing with robust quality control.

The test offer comprehensive mutation coverage and greater sensitivity than traditional sequencing methods, with results generated in less than five hours after sample preparation. It is also designed to work with the often poor quality of DNA derived from tissues normally processed in pathology labs (formalin-fixed, paraffin-embedded tissue).

• CE-marked under the European IVD Directive 98/79/EC
• Highly sensitive real-time PCR assay based on ARMS® and Scorpions® technology
• Simple work flow with same day results
• Detects mutations not visible by sequencing

For more information, read the product flyer or click here.


Ordering Information


Product Name

Cat. No.

TheraScreen®: K-RAS Mutation Test, 20 Tests 


TheraScreen®: K-RAS Mutation Test, 80 Tests


Increasing  Medical Value

Evidence to support the value of testing for K-RAS and EGFR mutations as a predictor of response to therapy is rapidly developing.

EGFR signaling pathway – Role of K-RAS mutations
larger version

K-RAS testing in metastatic colorectal cancer, the third most common cancer and the second leading cause of cancer death in the world, is now broadly accepted by key opinion leaders as a validated biomarker for predicting non-response to a class of drugs known as anti-EGFR antibodies. Two of these drugs – panitumumab (Amgen’s Vectibix®) and cetuximab (ImClone/BMS/Merck’s Erbitux®) – require K-RAS mutation testing prior to prescribing for patients with metastatic colorectal cancer in European markets.

LIGHTCYCLER is a trademark of Roche.
THERASCREEN and SCORPIONS are trademarks of DxS Limited.
ARMS is a trademark of AstraZeneca UK Limited.