Companion Diagnostics

Companion diagnostics domain falls within the larger field of study called pharmacogenomics, which employs the person’s genomic makeup to predict a drug response or to tailor therapy specifically for that patient. The US FDA depicts companion diagnostics as an in vitro diagnostic device or an imaging tool, which provides information essential for the safe and effective use of a corresponding therapeutic, preventive, or prophylactic product. These unprecedented diagnostic devices are the critical part of currently targeted cancer therapy regimens and impose a very good impact on the lowering of the unnecessary morbidity and providing the better treatment access to the patients.

For a long time, technologies such as quantitative real-time polymerase chain reaction, in situ hybridization, and immunohistochemistry have been traditionally used for diagnosing or detecting the relevant disease biomarkers however, due to the arrival of the high throughput sensitive approaches had changed the diagnostic scenario and thereby created a shift in the enabling technology platform for Companion Diagnostics. These high throughput technologies ranged from single molecule real-time sequencing, next-generation sequencing, and quantitative histopathology to digital pathology.

An excellent example of a companion diagnostic approval was the COBAS BRAF V600E test, which received simultaneous FDA marketing approval along with vemurafenib for metastatic melanoma patients. Other glaring example of already approved companion diagnostics kits are “Exjade Ferriscan drug-device kit for Thalassemia, Gleevec PDGFRB FISH drug-device kit for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease, Myelodysplastic Syndrome/Myeloproliferative Disease,l Herceptin (trastuzumab) INSITE HER‐2/NEU drug-device kit for Breast cancer, Keytruda PD‐L1 IHC 22C3 PharmDx drug-device kit for Non‐small cell lung cancer and Lynparza BRACAnalysis CDx drug-device kit for Ovarian cancer.

Currently, several major companies have pulled up their socks and are innovating the treatment outcomes of their respective interventions by entering in to “drug-device deals and; collaborations” to better tailor the treatments with their interventions.

Several Tier 1 companies that are evaluating their intervention in this arena are Eli Lilly which is evaluating Erbitux with CDx device Therascreen KRAS PCR by Qiagen for Colorectal Cancer, Novartis which is evaluating Mekinist by the utilization of THxID™ BRAF PCR Kit by bioMerieux for Melanoma treatment, Genentech is evaluating Tarceva and utilizing cobas EGFR mutation PCR test by Roche Diagnostics for Lung Cancer.

The field is very well sprung, as so many niche companies are also joining this trend to achieve significant outcomes of their respective interventions. However, a challenge to accurate and timely diagnostics is the difficulty in obtaining tissue specimen, but as so many approvals had already been made the role of the companion diagnostic in streamlining clinical trial participant selection had already opened the doors for further unprecedented approvals of other drug-device combos.