Project
The Innovative RT-qPCR based breast cancer subtyping kit provides advanced reproducible results.
We were approached by APIS Assay Technologies to validate a new and advanced breast cancer subtyping kit, which is improving the speed and accuracy for detecting certain types of breast cancer.
The kit can help direct clinicians to the right treatment more quickly with higher precision, improving patient outcomes.
The APIS Breast Cancer Subtyping Kit distinguishes between the many different types of breast cancer using a quicker, more specific molecular assay, which can be used to guide treatment for patients.
How the labs helped
We helped test the performance of the new RT-qPCR based assay to ensure it gives repeatable and reproducible results. The team demonstrated that not only were the same results produced when a sample was repeatably analysed, but that this result was reproducible – meaning it wasn’t affected by variations in manufacturing, the user or the laboratory facilities.
Outcome
The data we generated formed part of the test’s technical development and regulatory approval. Following this work, the APIS Breast Cancer Subtyping Kit is now a certified in vitro diagnostic (IVD) device.
Dr Ian Kavanagh, COO and co-founder of APIS Assay Technologies, said: “We are very excited to launch our new breast cancer subtyping kit, particularly since we are seeing links between the RNA expression and the stratification of HER2 expressing patients compared to classical methods like IHC.
“We are now able to provide a kit that delivers fast, accurate and reproducible results for the standard breast cancer biomarkers, including a faster HER2 result turnaround without the need for reflex testing when the IHC result is unclear.”