This document discusses the blurring line between diagnostics and prediction in genomics. It notes that 23andMe forced the FDA to create a new classification for predictive diagnostics, allowing people to learn their health risks in advance. This also allows companies to establish direct relationships with patients. The document also lists companies in the FDA's Pre-Cert Pilot Program, including Apple, Fitbit, Johnson & Johnson, and others in tech, medical devices, pharma, startups and non-profits. It provides sources from Deloitte analyses and the FDA on digital health and pre-certification programs.

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Image source: vectorstock

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Genomics is
blurring the line
of diagnostics
and prediction
23andMe forced the FDA
to create a classification
for predictive diagnostics
This allows people know
their risks in advance and
allows companies establish
direct relationships with
these patients.

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Source: Deloitte Analysis

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Source: http://apps.healthskouts.com

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* FDA Pre-Cert Pilot Program companies
• Apple (Cupertino, California)
• Fitbit (San Francisco, California)
• Johnson & Johnson (New Brunswick, New Jersey)
• PEAR Therapeutics (Boston, Massachusetts)
• Phosphorus (New York, New York)
• Roche (Basel, Switzerland)
• Samsung (Seoul, South Korea)
• Tidepool (Palo Alto, California)
• Verily (Mountain View, California)
IT 기업/ 의료기기 & 제약사
헬스케어 스타트업/ 비영리 단체가 참여

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Source: Deloitte Analysis

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Source: IMDRF

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Source: Deloitte Analysis

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Source: Deloitte Analysis

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https://www.fda.gov/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/ucm584020.htm

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