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Helix Aims to Deliver 'Sequence Once, Query Often' Goal to Consumers

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NEW YORK (GenomeWeb) – Consumer genomics company Helix launched this week with $100 million in investments from Illumina, Warburg Pincus, and Sutter Hill Ventures, with the goal of making sequencing available to consumers.

The San Francisco-based company plans to open a CLIA certified, CAP accredited, and HIPAA compliant laboratory in San Diego where it will offer next-generation sequencing and analysis on Illumina platforms. Helix plans to launch its first products in 2016.

Eric Endicott, director of global public relations and social media for Illumina, told GenomeWeb that Illumina would provide strategy and guidance to Helix through its board of directors, which is being chaired by Illumina CEO Jay Flatley. Illumina CFO Marc Stapley will also serve on Helix's board.

Endicott added that Illumina believes the consumer market is "a large opportunity that will be catalyzed by our technology."

Illumina declined to disclose how much of the $100 million investment it contributed, and whether it provided sequencing instruments as part of its investment.

Helix is not planning to sell whole-genome interpretation to customers, but will instead partner with third-party organizations that will develop products focused on very specific portions of the genome, similar to a targeted gene panel. Already, it has announced partnerships with the Mayo Clinic's Center for Individualized Medicine and Laboratory Corporation of America.

The Mayo Clinic, which has also invested in Helix for an undisclosed amount, will initially focus on consumer education and health-related queries. LabCorp plans to develop analysis and interpretation services as well as develop applications that address medically actionable genetic conditions.

The goal of Helix is to "empower the customer to discover insights into their DNA," Justin Kao, SVP of corporate development, operations and strategy at Helix, told GenomeWeb. Essentially, the company is aiming to make the "sequence once, query often" idea a reality.

Helix is in the process of building and validating its sequencing laboratory, Kao said. He declined to disclose specifics about the types and quantity of Illumina sequencers it would operate in its lab, but said it planned to be one of the largest sequencing labs in existence, capable of processing "millions of samples per year."

Helix is positioning itself as the platform provider — offering the sequencing pipeline and bioinformatics — but will not be developing the specific applications for querying the genome, Kao said. Instead, its partner organizations, like the Mayo Clinic and LabCorp, will develop the products and services.

"We'll continue to improve on the whole pipeline of sequencing and informatics, but we are committed to being a neutral and open platform," Kao said. "We will enable our partners to deliver insights to consumers while we focus on providing the infrastructure."

Another key to Helix will be its database, which it is designing to be HIPAA compliant and follow best practices for security and encryption, Endicott said. Customers will have full control over their own data and can delete their accounts and all data at anytime. Helix is focused solely on delivering products to consumers and will not use customer data for research purposes. In addition, partners developing applications will not have access to customers' entire genomic information, only the specific genomic regions on which its product is based. A customer only has to submit a sample for analysis one time. Helix does the sequencing and analysis and digitizes the customer's genome, Kao said. Customers can then order as many products as he or she wants and each time will go through a consent process for releasing the specified genomic regions.

Keith Stewart, director of the Mayo's Center for Individualized Medicine, told GenomeWeb that "the Center for Individualized Medicine sees this as a potentially very exciting and disruptive space in consumer genomics." Aside from providing services to consumers, the Mayo Clinic itself will begin to "understand how the consumer market will play out in the medical genomics field," he said. "We want to be part of the process and help educate consumers in the most trustworthy fashion that we can."

Stewart said the Mayo's initial applications would focus on genomic education and other applications that are wellness-related, but would not need a doctor's prescription or be regulated under the US Food and Drug Administration. Subsequent applications will likely become more disease-focused, he said.

The educational app would inform consumers about what can and cannot be interpreted from genomic data, Stewart said. Included in the educational app will also be information around genetic counseling.

Another potential early application may focus on pharmacogenomic variants, Stewart said. Over time, the Mayo Clinic may move into disease-specific applications. "There could be a whole range of options for the consumer," Stewart said, including the ability to assess carrier status or learn genetic risk for certain diseases. Such applications would have to be brought through FDA clearance, he said, and may also include recommendations to either validate the finding in a diagnostic laboratory or to discuss the data with a physician and/or genetic counselor, he said. But those details are still being worked out.

"The notion is that the consumer is in control," Stewart said. "The consumer decides how much information they want or don't want to learn."

LabCorp did not respond to request for comment on its applications.

Endicott said that Helix would be taking an "active role in ensuring the quality and regulatory status of applications on its platforms," and would provide regulatory assistance to partners and "actively engage with the FDA."

He added that the benefit to partners for working within Helix's system as opposed to simply developing their own tests is that they will not have the "burden of developing their own assay, laboratory, or data infrastructure," he said.

Because Helix is aiming to reach the consumer market, its price point must be consumer-friendly. Kao declined to disclose specifics on price and whether customers would pay an upfront price to Helix for sequencing and make subsequent purchases from partner organizations for specific tests, but said that the partners themselves would have flexibility in how they decided to price their products.

Kao said that while Helix intends to work closely with the FDA, initial applications developed by partners would likely not fall under the purview of the FDA, but would instead focus on questions related to genealogy, fitness, or other applications without significant medical or health implications.

As such, Helix will be competing in a growing and crowded consumer genomics market that includes 23andMe, Ancestry.com, National Geographic's Genographic Project, Family Tree DNA, and Pathway Genomics.

Currently, Pathway Genomics markets a fitness test to consumers while the remaining companies offer ancestry genotyping. Prices for these tests range from $99 to $200.

Helix will likely face the largest competition from 23andMe, whose tests run on Illumina's SNP arrays. The firm recently announced it had genotyped its millionth customer. Currently, it offers ancestry testing to US customers, but is looking to bring health-related testing through FDA clearance. The firm already offers a Personal Genome Service to customers in the UK for £125 ($195.54). That test screens customers' genetic risk for 11 health conditions, tests whether they have variants for 43 inherited conditions and 38 traits, and tests their likelihood of responding to 12 drugs. In addition, the company offers more than 100 health-related reports and ancestry testing for customers in Canada for $199 and in European countries Denmark, Finland, Ireland, Sweden, and the Netherlands for €169 ($186.97).

Earlier this year, 23andMe was cleared to offer screening for Bloom syndrome, but said it would not market the test until it completed the regulatory process for other inherited disorders so that it could sell a more comprehensive product.

Helix is not yet disclosing details of its business model and while individual products may be offered at consumer-friendly prices, it is unclear how it will offer genomic sequencing in the $100 to $250 range. Endicott said that the sequencing would be "affordable," but declined to specify what that meant.

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