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23 and You?

Updated: 6 days ago

Do you care about direct-to-consumer genomic testing? Here’s why you should!

Only 15 years ago, Time Magazine touted “The Retail DNA Test” as its Invention of the Year. The direct-to-consumer genomic test (DTC-GT) debut was credited with developing many increasingly cheap and efficient genomic sequencing techniques.

Why is this incredible? Well, because genomic testing is a superb innovation for "precision healthcare"—medical interventions that focus on identifying the precise genetic factors that underlie diseases and health risks, allowing patients to receive therapies tailored to their needs.

Pioneering genomic biotech firms such as 23andMe, Illumina, Veritas Genetics, Dante Labs Inc., Nebula Genomics, Navigenics and deCODEme gave consumers access to whole-genome sequencing and genotyping tests, previously available only through a clinical intermediary. 

Rapid and inexpensive methods like “next-gen sequencing” and “high-throughput sequencing” enabled an exponential decline in whole-genome sequencing costs, from over $100 million in 2001 to about $1000 in 2019 per genome. As of 2021, DTC-GT price points hover near an average of $200. With such a steep increase in affordability and the potential for a further decrease in cost per unit, the global DTC-GT market is projected to be worth $6.3 billion by 2028.

Only seven years after its inception, the DTC-GT global market was valued at “$117 million, suggesting that millions of people are purchasing these tests. In contrast to [expensive] clinical genomic testing, DTC genomic tests can be purchased online or even at your local pharmacy.” 

By making genomic test results more accessible and comprehensible to consumers and healthcare personnel alike, DTC-GT could be precision health’s ticket to mainstream implementation. DTC-GT promises results that are accurate enough for our highly regulated healthcare world but also attractive enough to court a consumer market currently experiencing a personal health zeitgeist.

The difference between clinical and consumer diagnostic viability exists because all clinical tests must have active FDA approval. However, a common misconception is that consumer genomic testing is unreliable because it is not as stringently regulated. Most of the pioneer genomic biotech firms, such as 23andMe and many others, require patient samples to be analyzed at CLIA (Clinical Laboratory Improvement Amendments)-certified and CAP (College of American Pathologists)-accredited labs as per federal regulations.

Many DTC-GT kits are also routinely regulated under the FDA’s analytic and clinical validity standards. Top DTC-GT firms in the country, such as 23andMe, have already received FDA marketing authorization for DTC-GT tests such as Bloom Syndrome. These firms proclaim that they will continue pursuing FDA authorization as their protocols develop.

Another misguided fear is that widespread patient access to DTC-GTs will result in the evasion of clinical guidance altogether. This notion is largely inaccurate because DTC-GT researchers emphasize strengthening patient-provider relationships through consultation and active clinical participation in a patient’s genomics journey. 

The DTC-GT market is far younger than other private healthcare markets, including pharmaceuticals, medical devices and diagnostic laboratories. Despite its progress over 14 years, it requires robust federal and private funding regulations, more innovation time, and stronger alliances with health delivery entities.

The more people opt for DTC-GT in the precision health paradigm, the more inexpensive, targeted and accessible precision health therapies can become.

Regardless of whether one opts for genomic testing, consumer genomics could play a pivotal role in creating affordable, accessible and accurate therapies and thus drive the incoming wave of precision health—and perhaps change the face of healthcare forever.

The opinions expressed in this article are those of the individual author.

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