Realizing the Power of Clinical and Consumer Genomics: Ethics, Business Models, and Regulatory Hurdles

By Emily Kong (Senior Analyst) and Amanda Sani (Senior Analyst)

Last month at the 2018 BIO International Convention in Boston, Health Advances Partner Vivek Mittal moderated a panel discussion on “Realizing the Power of Clinical and Consumer Genomics.” Panelists from Helix (Akwasi Asabere), Mindstrong Health (Elaine Cheung), and Canaan Partners (Julie Grant) debated issues related to the ethics, business models, and regulatory landscape for these innovative products and services. The result?

While it is clear that there indeed exists significant potential in this rapidly developing area of personalized medicine, much still needs to be solved before these can become mainstream. But the outlook is strong – our panelists believe that momentum is growing to move things forward.

Three key themes emerged from the conversation:

[1] Ethics and Data remain a controversial and ambiguous area for both companies and consumers. Julie Grant of Canaan highlighted the lack of awareness by consumers in how their health data, let alone genomic data, can be used. “How many people do we know understand that each and every prescription they have filled has been tracked to create companies like IMS?” she asked when comparing the challenge that the genomics industry faces. The distinction between data privacy and data security only becomes more obscure when genomics, particularly those consumer-targeted, provide only abstract descriptions of how one’s data will specifically be used.

Akwasi Asabere of Helix then highlighted the need for greater industry standards to ensure that consumer data is handled appropriately. As an example, he shared Helix’s efforts in developing a private-public consortia that will set standards as part of this effort. As part of these standards, truly informed consent from patients must be obtained.

Elaine Cheung of Mindstrong Health commented on this very need and highlighted the challenges of ensuring that patients truly understand how their data is being used and stored. She noted that Mindstrong has an Ethical-Legal-Social Implications Board to help ensure that its work on digital biomarkers is conducted in a way to build public trust.

[2] There is no clear consensus to the winning business model within clinical and consumer genomics, though a variety of approaches can likely prevail. While these products and services have been traditionally business-to-business (B2B) plays, the new crop of companies is challenging convention.

Helix, for example, is both a B2B and business-to-consumer (B2C) play that seeks to earn revenue by connecting services to end-users. However, whether Helix develops its own content remains to be seen, Asabere noted.

Mindstrong Health is also a mixed play in building a platform that is part diagnostic tool, part preemptive treatment. With only limited analogs available, the company is charting into new territory.

Whether a B2B, B2C, or mixed play ends up having the winning model within genomics is unclear– and may depend largely on the specific product. The jury’s still out on this one, and only time will tell.

[3] While questions remain on genomic data security and optimal business models, the panelists agreed on one thing: that the new guidance issued by the FDA on both lab developed tests (LDTs) and digital health has helped to advance the field and further investment. Though said guidance has yet to translate to formal regulation, market leaders like Foundation Medicine and Myriad have sought and received FDA approval for their products.

This sets a high bar for clinical data that additional players will need to meet to compete effectively in the market place. In turn, more formal approvals should alleviate concerns among payers and increase market access as a whole. Overall, the level of engagement and flexibility displayed by the FDA in recent years is a key development in spurring the industry forward.

Through the panel and following discussion, it is clear that the ethics, business models, and regulatory landscape of clinical and consumer genomics are continuing to evolve. Mindstrong Health, Helix, and others are paving the way for better clarity into how genomic data is being collected, stored, and used, and the collective industry may soon follow suit given recent legislative trends.

Between Europe’s new General Data Protection Regulation (GDPR) protections and California’s recent passing of the California Consumer Privacy Act of 2018, data privacy laws are becoming increasingly tough. Such laws will require companies that store large amounts of personal information to disclose what data, including genomic, is being collected and how it is being sold – and allowing consumers to opt out of this. While California’s new law is less expansive than EU’s GDPR and does not go into effect until January 2020, it does signal a clear shift toward more comprehensive data privacy measures within the United States. It is possible that between these new laws and conscious efforts by companies, privacy and security of genomic data may soon become a more concrete requirement, ultimately impacting which business models and products will succeed.

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