Is Genetic Testing Dead?

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Summary

• 💰 23andMe, a saliva-based genetic testing company, once diagnosed for 240 diseases.

• 🧪 Why did the FDA nearly shut the company down at one point?

• 🧬 How did hackers steal genetic data from 7 million customers?

• 💹 So, why is everyone talking about 23andMe again?

How Did 23andMe start?

Even before most people could tell the difference between a DNA and a gene, Anne Wojcicki, launched a genetic testing company to revolutionise healthcare: 23andMe.

Now, launching a massive biotech company like this would have been a challenge for most people, but not for Anne. Not only was she a biologist, but she was also in relationship with the Google co-founder Sergey Brin, who later convinced Google to invest $3.9 million into 23andMe.

💰 In 2007, 23andMe raised $9 million in Series A funding. This was a big deal for a biotech startup, especially at a time when biotech was considered a graveyard for startups. The challenge wasn’t just the science - it was also the regulations. Agencies, like the FDA almost killed her company at one point (more on that later).

Regardless of how she raised the money, Wojcicki had a vision that could have changed healthcare forever.

How? Through Preventative Medicine. 🧪

Where Did It Go Wrong?

In 2008, 23andMe was testing for almost 240 conditions, from baldness to blindness. This seemed like great news. But there was a catch - knowing you were at high risk for a condition didn’t always mean there was a way to reduce that risk.

🧬 Take Alzheimer’s disease, for example. Having a high-risk gene didn’t guarantee you’d develop the disease. Many conditions like Alzheimer’s are multifactorial, meaning they develop from a mix of genetic, environmental, and other lifestyle factors. Due to a lack of proper interventions for conditions like Alzheimer’s, learning about these risks often just led to anxiety rather than actionable steps.

Things were even worse with risk testing for diseases such as cancer. 23andMe wasn’t testing for all cancer-causing genetic variants, making their reports incomplete and sometimes even misleading.

🧫 In 2013, the FDA decided to step in. They banned 23andMe from sharing disease risk information with customers. In 2015, however, the FDA allowed them to provide reports on a limited number of conditions, such as BRCA1/BRCA2 mutations (linked to breast cancer) and Type 2 diabetes.

🚨 A Major Setback: The 2023 Data Breach

Just as 23andMe was rebuilding, a disaster struck.

🔓 In October 2023, the company suffered a massive data breach. Hackers stole data from 7 million customers and sold it online. How? 23andMe’s ancestry feature allowed users to see how closely they were related to their relatives. Hackers exploited this by breaching a single account and then accessing data from all linked family members.

Interestingly, the hackers specifically targeted people of Chinese and Ashkenazi Jewish descent before selling their data on the dark web.

📉 The fallout was brutal. By November 2024, 23andMe faced multiple lawsuits, fired 40% of its employees, and watched its entire board of directors resign.

What now for 23andMe?

Despite these setbacks, 23andMe still owns millions of genetic data points, which are valuable for their research initiatives. The company has been licensing this de-identified data for research studies, contributing to personalised medicine.

⚖️ This data can play a key role in finding cures for those affected by rare diseases. Rare diseases are actually not rare! Almost 300 million people worldwide have them, which is similar to the current U.S. population. While some might see this as an invasion of privacy, others, including myself, see it as a step towards better treatments for unique and rare diseases.

However, selling data alone won’t be enough to save 23andMe.

💰 A Surprising Turn: Going Private Again

Recently, Anne Wojcicki proposed a $74.7 million deal to take 23andMe private again. After the announcement, the company’s stock jumped 33%, but that’s still nowhere near its value in the past.

Why would Wojcicki reinvest in a company that lost almost 98% of its values?

Simple, its for the valuable data from the 14 million customers that the company still holds. 23andMe has also spent millions on research and drug development.

⚖️ The Legacy of 23andMe

Despite its struggles, 23andMe has made a lasting impact. It drastically reduced the cost of genetic testing, making it more accessible to people. While the company has faced many challenges, its work has paved the way for other consumer genetic testing companies like Nucleus Genomics to learn from its mistakes and push science forward.

So, is genetic testing dead? No. However, the story of 23andMe is an important lesson for young entrepreneurs. A reminder that research, innovation, regulation, privacy, and business must all work together for long-term success.

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