Developments

Use of standards in FDA regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics used for diagnosing Germline Diseases (Draft Guidance)

Government
Agency
Genetics/Genomics

Original Development Brief – Provides recommendations for designing, developing and validating NGS-based tests for rare hereditary diseases and addresses the potential for using FDA-recognized standards to demonstrate analytical validity.

Updated last August 8, 2016

for the 07/08/2016 draft guidance.

Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing Based In Vitro Diagnostics (Draft Guidance)

Government
Agency
Genetics/Genomics

Original Development Brief – Provides guidelines to aggregate, curate and interpret publicly accessible genetic variant databases and outlines conditions for their FDA recognition.

Updated last August 8, 2016

for the 07/08/2016 draft guidance.

Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act (HR 3381/ S 1883, 114th Congress)

Government
Elected Body
Genetics/Genomics

Instructs numerous federal agencies to pursue activities to benefit pediatric cancer victims and finds that the National Cancer Institute supports a variety of related genomics research.

Updated last July 29, 2015

Compromise Bioengineered Food Labeling Legislation (Public Law 114-216)

Government
Elected Body
Executive
Statute
Genetics/Genomics

Original Development Brief – Requires the establishment of a national disclosure standard for bioengineered foods.

Updated last July 29, 2016

for Public Law 114–216

Genomic Sampling and Management of Genomic Data (Draft Guidance)

Other
Genetics/Genomics

Original Development Brief – Creates an international guideline for genomic sampling and the management of genomic data in clinical studies to harmonize standards and enable globally consistent research.

Updated last July 19, 2016

for the 12/10/15 draft guidance noticed via the federal register on 6/3/16

Rapid DNA Act of 2016 (S 2348, 114th Congress)

Government
Elected Body
Genetics/Genomics

Original Development Brief – Aims to create standards for the use of Rapid DNA instruments in law enforcement and criminal investigations.

Updated last July 11, 2016

for the 6/16/16 version of S. 2348.

Sexual Assault Survivors’ Rights Act (S 2566, 114th Congress)

Government
Elected Body
Genetics/Genomics

Original Development Brief – Aims to specify rights for sexual assault survivors regarding medical forensic examinations and evidence collection kits, including being informed of a DNA profile match.

Updated last July 8, 2016

for the 2/23/2016 version of S. 2566

District Court for the Northern District of Georgia rules on privacy rights under the Genetic Information and Nondiscrimination Act (Lowe v. Atlas Logistics Group Retail Services LLC)

Government
Judicial
Genetics/Genomics

Original Development Brief – Awards plaintiffs $2.2 million in compensatory and punitive damages in the first case interpreting the scope of genetic privacy under GINA.

Updated last June 20, 2016

for 05/05/2015 decision.

Visa Integrity and Security Act of 2016 (HR 5203, 114th Congress)

Government
Elected Body
Genetics/Genomics

Original Development Brief – Expands background checks to include DNA testing and other measures to improve immigration security and detect visa fraud.

Updated last June 13, 2016

for the 05/12/2016 version of HR 5203.

Biotechnology Food Labeling Uniformity Act (S 2621, 114th Congress)

Government
Elected Body
Genetics/Genomics

Original Development Brief – Requires that food with ingredients from genetically modified organisms (GMOs) be labeled as genetically engineered.