Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Is the Era of DTC Diagnostics, Diagnosis and Drug Development Here?

Is the Era of DTC Diagnostics, Diagnosis and Drug Development Here? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Givi Topchishvili is founder and president of the 9.8 Group.


23andMe, the direct-to-consumer genetic testing and screening service, is back in the business of analyzing some health risks based on personal genetics.


That's probably good news for health-curious and health-conscious customers (or at least those in the US since 23andMe has been offering the service in Canada and Great Britain all along).


23andMe has pioneered a new health service business that could serve as an early working prototype for the entire medical industry over the next few years. Despite conventional wisdom that the 23andMe business breakthrough is the direct-to-consumer model, it's also the consolidation of genetic testing, diagnosis and drug development that has the potential to change the industry.


Pharma Guy's insight:

Before putting all your eggs in this basket, you should know that data from studies that investigate the quality of these DTC genetics tests confirm that they are not informative, have little predictive power, and do not measure genetic risk appropriately. See here: http://sco.lt/4o3AY5 

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Direct-to-Consumer Genetic Tests (DTC-GT), Easy to Purchase, But Pretty Useless

Direct-to-Consumer Genetic Tests (DTC-GT), Easy to Purchase, But Pretty Useless | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Data from studies that investigate the quality of the tests offered confirm that they are not informative, have little predictive power, and do not measure genetic risk appropriately.


BackgroundDirect-to-consumer genetic tests (DTC-GT) are easily purchased through the Internet, independent of a physician referral or approval for testing, allowing the retrieval of genetic information outside the clinical context. There is a broad debate about the testing validity, their impact on individuals, and what people know and perceive about them.


ObjectiveThe aim of this review was to collect evidence on DTC-GT from a comprehensive perspective that unravels the complexity of the phenomenon.


MethodsA systematic search was carried out through PubMed, Web of Knowledge, and Embase, in addition to Google Scholar according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist with the key term “Direct-to-consumer genetic test.”


ResultsIn the final sample, 118 articles were identified. Articles were summarized in five categories according to their focus on (1) knowledge of, attitude toward use of, and perception of DTC-GT (n=37), (2) the impact of genetic risk information on users (n=37), (3) the opinion of health professionals (n=20), (4) the content of websites selling DTC-GT (n=16), and (5) the scientific evidence and clinical utility of the tests (n=14). Most of the articles analyzed the attitude, knowledge, and perception of DTC-GT, highlighting an interest in using DTC-GT, along with the need for a health care professional to help interpret the results. The articles investigating the content analysis of the websites selling these tests are in agreement that the information provided by the companies about genetic testing is not completely comprehensive for the consumer. Given that risk information can modify consumers’ health behavior, there are surprisingly few studies carried out on actual consumers and they do not confirm the overall concerns on the possible impact of DTC-GT.


ConclusionsThe impact of DTC-GT on consumers’ health perceptions and behaviors is an emerging concern. However, negative effects on consumers or health benefits have yet to be observed. Nevertheless, since the online market of DTC-GT is expected to grow, it is important to remain aware of a possible impact.


Pharma Guy's insight:

As our age transitions to one where more consumers are more actively involved in their own healthcare, FDA has once again acted on the matter of genetic tests that are marketed directly to consumers. Recently, the agency sent three untitled letters – as opposed to warning letters (and note, these are not letters from the Office of Prescription Drug Promotion – OPDP) to manufacturers and marketers of genetic tests meant to inform the consumer whether they have a genetic predisposition to various conditions. This follows other actions the agency has taken with respect to this topic, some going back to 2010. The letters, including a warning letter sent in 2013 to another manufacturer, can be found here.

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