Written by Bill Finger, Managing Director, Kineticos
In a recent article, I discussed the complexity of the Companion Diagnostics landscape. The key takeaway was that strong science and a novel technology are not the only critical success factors, and that engaging all relevant parties (pharma/biotech, diagnostics, regulatory agencies, payers, etc.) early in the process is paramount. It’s equally important to take a strategic approach when it comes to determining a therapeutic focus.
Not surprisingly, we’re seeing more companies investing in oncology companion diagnostics than any other therapeutic area. Specifically, breast, non-small cell lung, colorectal, melanoma and gastric cancers are among the leading applications for companion diagnostic targets. Below is a small sampling of companies that have opted to focus their efforts in oncology.
Abbott’s Vysis Chronic Lymphocytic Leukemia (CLL) fluorescence in situ hybridization (FISH) kit has been granted premarket approval for AbbVie and Genentech’s drug, Venclexta (venetoclax). This assay targets the TP53 deletion, which identifies whether the CLL patient would benefit from Venclexta. Many treatment options exist for CLL; thus, being able to develop tests that identify patients that will benefit from one therapy versus another is vital.
While not as far along in the development pathway, Leica Biosystems and Merrimack Pharmaceuticals are in partnership to develop companion diagnostic assays for the investigational oncology therapy Seribantumab. In this agreement, assays that measure heregulin, proteins that activate a cell surface receptor called ErbB3, are being developed to help identify a cancer phenotype.
Oncology is clearly a popular area to be in, but it is by far not the only therapeutic area worth exploring. Examples of companion diagnostics in other areas include:
- Kalydeco® (ivacaftor) for cystic fibrosis is paired with COBAS 4800 BRAF V600® from Roche Molecular Systems
- Selzentry® (maraviroc) for HIV has Trofile®, an HIV coreceptor tropism assay from Monogram Biosciences (now Labcorp)
- Increlex® (mecasermin) for severe growth failure requires an insulin-like growth factor 1 reference LDT
There is clearly opportunity across therapeutic areas when it comes to developing companion diagnostics. In fact, many companies have technology that can be applied across therapeutic areas. It’s important to look at analogs across each therapeutic area when determining a focus because applying learnings from past successes and failures can be an effective and efficient way to enhance a strategy.
Bill Finger, Managing Director of Kineticos’ Diagnostics Practice, brings 20 years of diagnostics and laboratory experience to the team. His team is focused on helping diagnostic companies maximize their commercial potential at the corporate and product levels while ensuring companies operate in an efficient manner.
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