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Outside the Lab Profession, Companion diagnostics, Technology and innovation, Precision medicine, Clinical care, Screening and monitoring

Inside Industry

What does it take to create a competitive companion diagnostic? Bharathi Vennapusa outlines her role in the development and approval of the ALK CDx – a fully-automated immunohistochemistry assay that identifies lung cancer patients who may be eligible for treatment with crizotinib.

At a Glance

  • A career in industry can be hugely rewarding for pathologists, especially with the rising interest in companion diagnostics
  • Working to develop the ALK CDx assay, Bharathi Vennapusa explains how regulators are rethinking their strategy to encourage personalized therapy and diagnostic approvals
  • Challenges remain to developing a good companion diagnostic, though, including difficulty in procuring tissue and reimbursement
  • But there continues to be substantial growth in the field which, in the future, is likely to see more multiplexing and digital solutions

How did you get involved in companion diagnostics development?

After training as a pathologist and specializing in molecular pathology, I decided I wanted a career that was neither entirely basic research nor clinical practice. I didn’t know much about companion diagnostics at that time, but through a friend I learned about Ventana Medical Systems (now a member of the Roche Group), which was active in the field. Pathologists often don’t consider careers in pharma, but I became inspired by the prospect after reading a journal article by Ventana’s Chief Medical Officer, Eric Walk, which discussed the role of pathologists in the industry. I decided I wanted to get involved, so I joined Ventana as a pathologist in companion diagnostics.

The role allows me to get involved in research that can be translated into clinical practice. Certainly, our biomarker assays can be used for research, but our main goal is to develop assays that can be used in the clinic. We all have our own reasons for joining the company – some may have family members afflicted with cancer, for example – but we all share a real personal interest in improving the lives of cancer patients. In reality, companion diagnostics are the cornerstone of personalized healthcare; they are critical to finding the right treatment for the right patient.

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About the Author

Bharathi Vennapusa

Bharathi Vennapusa is Director Clinical Operations at Ventana Medical Systems, Tucson, USA.

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