Gene Testing: Future Problem or Just a Blip?

Lisa Henderson

According to data from IQVIA Insights on the oncology pipeline (April 2019), of 15 new active substances launched in 2018, nine featured a predictive biomarker in their trial. Of those nine trials, one approved in non-small cell lung cancer could address over five million patients. The point is that it is a long-held belief, which appears to be bearing out, that as medicine trends toward more personalization, a biomarker of the disease will need to be a part of a patient’s work-up in order to be in a clinical trial and/or receive the approved therapy. In cancer, that could be in the tumor tissue identification, or a blood test, such as the PSA for prostate cancer. But also biomarkers exist for cholesterol and coronary artery disease and further into the genetic testing area.

Many initiatives around using an individual’s lab tests, routine or otherwise, to find an appropriate clinical trial have been introduced in recent years. Somewhat of a holy grail is to match the right patient to the right trial via a biomarker. So when I recently read that 23andMe was laying off 100 people, representing 14% of its total workforce, as well as cutting back on clinical studies, I was surprised. The reason for the move was a decline in consumer demand for the genetic tests, which is now leading the company to focus on building consumer trust in its genetic data, as well as focus on its work in therapeutics.

Recent ventures in clinical trials by 23andMe include the launch of the Fox Insight Data Exploration Network, or Fox DEN. This initiative, announced in April of last year, joining The Michael J. Fox Foundation for Parkinson’s Research and the 23andMe network, contains patient-reported outcomes, de-identified genetic data, and data exploration tools from the largest cohort in Parkinson’s disease research, including, genetic information from 23andMe customers who have joined the Fox Insight study.

There is also the recent announcement from TrialSpark and 23andMe, revealing a joint trial offering that seeks to improve the clinical study recruitment space, using genetic data.

Gaining or regaining the trust factor of a large consumer pool that has taken, or is now shying off from taking, a gene or ancestry test because of privacy concerns is a pretty big hurdle for a company dealing with the general public. And as our Managing Editor Michael Christel addressed in this article on patient health data, the ownership of such data is an area of concern. However, as also noted in the article, there is no such thing as an “average” patient, so how one person feels about sharing data and information, especially in a clinical trial, will not be consistent.

Anecdotal information is that trial participants want to share data to improve their lives or the lives of others, but they also want that data shared back to them, as well as final clinical trial results. This will continue to be a space to watch.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mmhgroup.com. Follow Lisa on Twitter: @trialsonline