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Industry perspectives on prenatal genetic testing.

Amy Swanson1, James D Goldberg2

  • 1Illumina, Inc., 499 Illinois Street, Ste 210, San Francisco, CA 94158, USA.

Seminars in Perinatology
|September 23, 2018
PubMed
Summary
This summary is machine-generated.

Industry is now leading prenatal genetic test development, raising questions on regulation and conflicts of interest. Collaboration between industry and healthcare providers is key for effective test utilization.

Keywords:
Commercial laboratoriesDiagnosticsDiagnostics developmentIndustryPrenatal genetic tests

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Area of Science:

  • Genetics
  • Medical Diagnostics
  • Healthcare Industry

Background:

  • Historically, academic physicians and labs dominated prenatal genetic test development.
  • Recent years have seen significant industry leadership in developing and implementing novel prenatal genetic tests.
  • Industry involvement raises concerns regarding regulatory oversight, result reporting consistency, and conflict of interest management.

Purpose of the Study:

  • To address concerns surrounding industry-led prenatal genetic test development from an industry perspective.
  • To discuss regulatory aspects, result reporting, and conflict of interest management in the context of commercial prenatal genetic testing.
  • To highlight the importance of collaboration between industry and healthcare providers.

Main Methods:

  • The article presents an industry viewpoint on the development and implementation of prenatal genetic tests.
  • It examines regulatory frameworks and ethical considerations pertinent to commercial diagnostics.
  • The authors discuss the role of industry-funded clinical trials and their impact on clinical practice.

Main Results:

  • Industry possesses resources for developing and offering innovative genetic tests.
  • Concerns regarding diagnostics development regulations, result reporting, and conflicts of interest are acknowledged.
  • The necessity of industry collaboration with healthcare providers is emphasized.

Conclusions:

  • Industry plays a vital role in advancing prenatal genetic testing technology.
  • Addressing regulatory and ethical questions is crucial for responsible innovation.
  • Effective and appropriate utilization of novel prenatal genetic tests hinges on strong collaboration between commercial entities and healthcare professionals.