As HER2 testing evolves, so does Clarient. With the help of our internal medical staff and advisory board members, we are able to keep up on changes for HER2 testing as well as collaborate in CAP and ASCO thought leadership forums. Working with significant affiliations, enables Clarient to continue to stay at the forefront of the HER2 testing marketplace.
Currently, Clarient is one of the largest providers of HER2 testing, always striving to use FDA-cleared products when possible. We have strict adherence to manufacturer guidelines, as well as extensive validation to support our testing methodologies.
Because of the importance of HER2 testing — and the challenges it entails — our lab uses state-of-the-art image analysis tools to help increase the consistency and reproducibility of your IHC and FISH results. Using image analysis tools help us to provide our customers with consistently high precision on their scoring, and attain results that are correlated and read by a licensed pathologist.
As well as performing HER2 by IHC and FISH, Clarient offers HER2 by PCR to help address circumstances where molecular approaches can help fill in the gaps.
Along with the HER2 assay, we also perform testing for other markers that may influence the HER2 pathway, including:
- TOPOIIa, shown to be valuable in influencing anthracycline-based therapy
- C-MYC, shown to influence Herceptin® sensitivity
From a quality and regulatory perspective, Clarient subscribes to HER2 Proficiency Testing through CAP, NEQAS (Great Britain), and NORDIC QC (Europe).