Profile of a personal genetics company: PHENOMBio

static squarespace

About a year ago, two former colleagues decided to start a personalized genetic-testing company, PHENOM Biosciences, which also goes by the name “PHENOMBio”. Their website claims: “whether it’s losing weight, training for that marathon, building lean muscle mass, or living a healthy lifestyle, our DNA Analysis Services will help you reach your goals by providing you with knowledge of your personal genetic information so you can custom-fit a diet and training plan that is specific to you.”

Their project recently launched, but the company struggled to deal with the FDA’s recent warning to 23andMe, a direct-to-customer personalized genomics testing company that was providing health-risk information to customers, and its implications. Since the crackdown, 23andMe provides US customers with ancestry reports and recently announced that it would be expanding its services to Canada, where customers will receive ancestry and health information. I asked the PHENOMBio crew to answer a few questions that I had, regarding what the FDA’s move meant for start-ups of small and large scale that may wish to move into the personalized genomics space.

Before we start the Q&A, here’s a brief explanation on the service that both 23andMe and PHENOMBio provide: the customer receives a kit in the mail instructing him/her to spit in a provided tube. The container is mailed back to the service provider who extracts DNA from the spit. That DNA is processed and analyzed for hundreds of thousands variants known to exist in our DNA. Unlike a DNA sequencing service, it doesn’t analyze all the DNA in the sample: it just tells you what DNA sequence you have at very specific spots in the genome. The company provides you with a report letting you know if your DNA variants are associated with an increased or decreased risk for a feature that it reports on. 23andMe was providing customers with personalized information on a whole slew of features; some of these were entertaining, such as the odds that you have blue eyes or that cilantro tastes bad to you. But some features had deep implications, such as whether or not you may have a mutation in a gene associated with breast cancer. PhenomBIO provides you with personalized information on diet and exercise routines.

Q&A with Jason Kim, CEO of PHENOMBio

Q: Hi Jason, thanks for taking the time to answer my questions. First of all, why start a company in this space? It seems that 23andMe already took a big chunk out of the direct-to-consumer genetic testing market, particularly early adopters?

My pleasure. As you know, the past couple of decades have seen an explosion in the advancements and discoveries in the field of genetics. Advancements the mainstream public is still mostly unaware of, and even worse, unable to take advantage of.

While 23andMe did a lot to bring more visibility to the power of genetic testing they still stopped short of providing information people could use to make beneficial decisions in their lives. Many people were still left asking the question, ‘OK, I got all this interesting genetic information about myself, now what?’. There was very little people could do with their genetic information with regards to applying it to their everyday lives.

Q: Were you surprised when the FDA made its announcement regarding 23andMe?

I wasn’t surprised. I recall the first time I saw their commercial on television I turned to my then Chief of Medicine and commented that the FDA wasn’t going to like this. They were making some very bold claims.

Q: What did it mean for you and your company?

In all honesty, it didn’t change much as we were always aware that the direct-to-consumer genetic testing industry could come under FDA scrutiny at any moment.

Q: Where do you see direct-to-customer personalized genomics testing in 1 year and 5 years?

It’s hard to say given that the FDA still hasn’t decided what it’s ultimately going to do with this industry in terms of regulation. But my short-term outlook is not a good one. I fear that within the next few years this industry will become rife with modern-day ‘snake oil salesmen’ pushing outrageous claims and overpromising on what their tests can do for customers with little to no scientific evidence backing their claims. Needless to say this will end up creating a huge setback in public perception for personalized genomics.

Q: I think that the FDA’s got a tough job: they want to prevent harm to patients and consumers, but are constantly pushed to minimize interference so that the economy and the biotech sector can expand. Do you think that the FDA should regulate direct to customer genomic tests? What about lab developed tests (LDTs)?

I don’t envy the powers-that-be at the FDA tasked in making this decision. The short answer is, yes, I believe there should be regulation in this industry. Without regulation of some sort you put the consumer at great risk of making incorrect decisions about their health based on false, flawed or incomplete data. However, over-regulation can stifle growth and innovation. So there definitely has to be a balance.

The question the FDA has to answer is, are they concerned with the way the data is collected and its accuracy or how the data is interpreted? I suspect it’s the latter and that is a much larger challenge in and of itself. But where they place the bigger concern is what will be what defines and shapes future policy. The industry is going to have to go through some tough growing pains with the FDA.

Q: In an age where keeping information private is increasingly difficult, is data generated by direct-to-consumer at risk of being targeted?

Is there a risk? Absolutely. How big that risk is will be determined by the perceived value of said data to someone or a company wanting that information. Oft cited examples for potential abuse of this data typically point to insurance companies and pharmaceutical companies. But people also don’t realize that this information can be used to predict consumer behavior for more everyday products and services.

Currently, there are no laws protecting the privacy of genetic information. There are some laws and rules in place preventing certain groups from discriminating based on genetic information, but there is no real mechanism for the enforcing of those laws.

With the case of our company, we choose to follow the same methodologies used in handling patient medical data. The data is accessible to you and you alone, and only you can make the call on whom you decide to share it with. There are no personal identifiers in the system linking to your data to keep the information safe, secure and confidential.

A final note on this subject is that people should be far more careful with choosing a genetic testing company they can trust. There are many testing companies out there whose business models revolve around amassing genetic data to later sell to other companies.

Q: Are there regulations regarding how data should be stored? If not, do you think there should be?

There are no regulations that we are aware of and that’s downright frightening. Data breaches are a very real risk. Again, how big that risk is completely determined by how valuable the information is.

In this day and age, if a person wants to get their hands on someone’s data they’ll eventually find a way. We are by no means under any illusion that we can build a system that will be hacker-proof. If we could we would be in a very different business. But we can take as many measures as possible to keep our data safe. We not only use strong encryption but we use a proprietary multi-layered data fragment process for storage. Think of it like someone stealing a 1000-piece jigsaw puzzle set but they don’t have the reference picture of what it’s supposed to look like. Yes, with enough time and resources, they’ll eventually figure it out, but it’s not going to be easy.

Q: As a follow-up question, who owns the data that is generated: the customer or the company?

That’s an extremely difficult answer that I honestly don’t know. There are good arguments for both sides and it’s circumstantial. Again, there are no regulations or laws governing this and so the best way I can answer is to advise people to engage with the company you plan to have your genetics tested through to make sure their policies align with your beliefs. If you strongly believe you should own the data, you are better served avoiding companies who claim ownership to all data generated.

Q: Could you briefly describe how your product works?

Certainly! Our service starts by providing a client with a DNA collection kit that includes a very easy to use swab to capture saliva. This is then mailed back to our labs where it is processed. Once processing is complete the data is analyzed by our software and the results uploaded to the client’s secure online profile within our CHANGE System. The client can then input biometric values as well as select a goal (such as losing fat or gaining muscle strength) and the system crunches the numbers along with the client’s genetic information to provide details toward reaching that specific goal.

Q: Do you think that the average person understands what personalized genomics is about? Do you find this to be a roadblock in your company’s development?

I’ve found that the level of understanding of personalized genomics varies greatly by geographical regions. I believe this is correlated to how a particular society as a whole views and treats science in general. That being said, our product development has always centered around making information as easy as possible to understand and apply regardless of one’s level of scientific knowledge or background.

Q: There are articles and websites with phrases such as “control your epigenome!” or “take your microbiome into your own hands!”. As a scientist who promotes skeptical thinking, how much evidence is there to support the claims made by PHENOMBio?

We very much encourage people to approach all genetic testing claims with a healthy amount of skepticism, even the tests offered by our company.

I am very proud of the lengths we have gone to ensure that we have strong evidence to support our products and information. It starts with a database created using data exclusively from peer-reviewed published papers in highly credible scientific journals. The database and any scientific claims then go through a rigorous review by our scientific review board. Finally, applied information goes through an extensive process of approvals through our medical review board. I, nor the senior management team, do not sit on any of these boards to allow decisions to be made purely on the basis of scientific and medical merit without bias regarding the business’ needs.

Layla Katiraee, contributor to the Genetic Literacy Project, holds a PhD in molecular genetics from the University of Toronto and is a senior scientist in product development at a genetic biotech company in California. All opinions and views expressed are her own. Her twitter handle is: @BioChicaGMO

Disclosure: I have not used PHENOMBio’s product nor 23andMe’s products, however, I plan to do so in the future. My husband used 23andMe’s product before it stopped providing health risk information. As stated above, the company’s owners are former colleagues, but I do not own any shares in the company, nor do any of my family members, and I am not receiving compensation of any form for this interview.

{{ reviewsTotal }}{{ options.labels.singularReviewCountLabel }}
{{ reviewsTotal }}{{ options.labels.pluralReviewCountLabel }}
{{ options.labels.newReviewButton }}
{{ userData.canReview.message }}
screenshot at  pm

Are pesticide residues on food something to worry about?

In 1962, Rachel Carson’s Silent Spring drew attention to pesticides and their possible dangers to humans, birds, mammals and the ...
glp menu logo outlined

Newsletter Subscription

* indicates required
Email Lists
glp menu logo outlined

Get news on human & agricultural genetics and biotechnology delivered to your inbox.