23andMe’s plan to harness data for disease treatments

Earlier this year, 23andMe announced it would be starting a new business.

The nearly 10-year-old biotechnology company headquartered in Mountain View, California formed a new therapeutics division, which would be responsible for using 23andMe’s large database of genetic information to discover and develop drugs for a litany of diseases, according to Time Magazine.

Richard Scheller, an experienced research and development executive from Genentech, was hired by 23andMe in March to run this new part of the firm.

23andMe amassed genetic data from 900,000 customers after spending several years selling saliva-based genetic tests, although Time notes only 80 percent had agreed to have their information used for medical research.

Scheller told Time this specific database is where he wanted to find any discernible clues that could lead to new therapies.

The Role of Data Analysis

In April, 23andMe hired Dr. Robert Gentleman as its vice president of computational biology to help put this plan into action.

Dr. Gentleman is a noted expert in bioinformatics, and his role involves devising a number of data-oriented methods to help the therapeutics team efficiently sort through all genetic profiles and quickly find any actionable targets for potential drugs.

“I came to 23andMe because it gave me the opportunity for a different take on drug development — one based more directly on genetics,” Dr. Gentleman said exclusively to Bioscience Technology (BST) in a phone interview.

Reuters reports that analyzing DNA is becoming an important part of the drug manufacturing process because the lower cost of genetic sequencing could potentially cut down on the time it would take to find new targets for treatment.

Reuters cites Regeneron Pharmaceutical as a corporate entity who has found success with this approach. Regeneron has reportedly identified multiple gene targets, particularly one that plays a role in obesity, from its own database of 250,000 volunteers that it began building in January 2014.

“Drug development is so risky, but 23andMe’s large database of genetic information provides us with substantial tools to identify strong opportunities to develop novel therapeutics,” said Dr. Gentleman. He explained to BST how 23andMe has an advantage over competitors in terms of the size of the archive he has at his disposal.

23andMe’s Partnerships

So far, the therapeutics team has two major medical research projects currently underway.

In January, Genentech and 23andMe said they were working together on finding a cure for Parkinson’s over the next few years. 23andMe will conduct full genome sequencing on an estimated 3,000 people afflicted with the disease found in the database. The results of this investigation will be used by Genentech to find new therapeutic targets for the disorder.

A few months later, Pfizer and 23andMe revealed they are enrolling participants in a year-long study of Lupus disease. 23andMe will do all of the necessary data collection and analysis. Once the experiment is completed, 23andMe will present the findings in 2016 to the researchers at Pfizer, who may use this insight to develop new drugs capable of treating the disease.

The Road Ahead

No specific details in regard to new partnerships or which diseases would be targeted were provided to BST, but 23andMe did say the therapeutics team will delve into the genetic database and search for the best treatment opportunities.

Andy Page, the biotech firm’s president said to BST, “23andMe will always be a consumer-driven company and customer engagement remains one of our top priorities.” He emphasized how important consent of sharing information and feedback from the community found in the database is to the therapeutics division’s work.

23andMe was ordered by the U.S. Food and Drug Administration (FDA) to stop marketing its saliva-based genetic tests in November 2013 because the agency said there was not enough evidence provided to validate claims about how accurately the tool could detect health conditions.

Executives from the enterprise complied with the directive from the FDA and stopped offering the test in December 2013. The FDA conducted a thorough regulatory review process the following year while the company spent that time period offering ancestry kits and uninterpreted genetic information to interested consumers while also meeting with a bevy of pharmaceutical companies, according to FierceBiotech. Since then, executives have reoriented their entire structure and shifted the business to focus on the database at its center.

Further progress was made in February 2015. Anne Wojcicki, the CEO of the company, published a blog post saying the FDA granted marketing authorization for a new genetic test aimed at detecting a disorder called Bloom’s Syndrome.

The post noted this approval “gives 23andMe a regulatory framework for future submissions.” No specific details in regard to new partnerships or which diseases would be targeted were provided to BST, but 23andMe did say the therapeutics team will delve into the genetic database and search for the best treatment opportunities.

Andy Page, the biotech firm’s president said to BST, “23andMe will always be a consumer-driven company and customer engagement remains one of our top priorities.” He emphasized how important consent of sharing information and feedback from the community found in the database is to the therapeutics division’s work.

23andMe was ordered by the U.S. Food and Drug Administration (FDA) to stop marketing its saliva-based genetic tests in November 2013 because the agency said there was not enough evidence provided to validate claims about how accurately the tool could detect health conditions.

Executives from the enterprise complied with the directive from the FDA and stopped offering the test in December 2013. The FDA conducted a thorough regulatory review process the following year while the company spent that time period offering ancestry kits and uninterpreted genetic information to interested consumers while also meeting with a bevy of pharmaceutical companies, according to FierceBiotech. Since then, executives have reoriented their entire structure and shifted the business to focus on the database at its center.

Further progress was made in February 2015. Anne Wojcicki, the CEO of the company, published a blog post saying the FDA granted marketing authorization for a new genetic test aimed at detecting a disorder called Bloom’s Syndrome.

The post noted this approval “gives 23andMe a regulatory framework for future submissions.”

________________________________________________________
05/28/2015
Ryan Bushey, Associate Editor
Bioscience Technology

2016-11-02T15:40:17+00:00