Developments

Supreme Court rules on patent rights attributed to identification of genes (Association for Molecular Pathology v. Myriad Genetics, Inc.)

Government
Judicial
Genetics/Genomics

Original Development Brief – Rules on the patentability of identified gene sequences by biotech companies that has reconceptualized our understanding of patent application in the field of biotechnology.

Updated last December 8, 2016

for the 6/13/13 case.

Requirement for Nondiscrimination Against End-Users of Supplies or Services (“Beneficiaries”) Under USAID-Funded Contracts (Proposed Rule)

Government
Agency
Genetics/Genomics

Original Development Brief – Amends USAID Agency for International Development Acquisition Regulation (AIDAR) to include a new clause entitled “Nondiscrimination against End-Users of Supplies or Services,” which specifically mentions genetic information.

Updated last August 22, 2016

Amendments to Regulation Under the Genetic Information Nondiscrimination Act of 2008 (Final Rule)

Government
Agency
Genetics/Genomics

Original Development Brief – Clarifies the extent to which an employer may offer an inducement to an employee for the employee’s spouse to provide information about the spouse’s manifestation of disease or disorder as part of a health risk assessment administered in connection with an employer-sponsored wellness program.

Updated last August 16, 2016

for the 5/17/16 draft

Health Equity and Accountability Act of 2016 (HR 5475, 114th Congress)

Government
Elected Body
Genetics/Genomics

Original Development Brief – Among other aims, seeks to improve the health of minorities, women and children, by addressing genetics. Among other aims, seeks to improve the health of minorities, women and children, by addressing genetics.

Updated last August 15, 2016

for the 6/14/16 version of H.R. 5475

Administrative Changes and Clauses to USAID Acquisition Regulation (Final Rule)

Government
Agency
Genetics/Genomics

Original Development Brief – Amends multiple elements of the United States Agency for International Development Acquisition Regulation (AIDAR), including creating a requirement that all contracts include a nondiscrimination clause, which addresses genetic information.

Updated last August 10, 2016

for the 07/26/2016 Final Rule.

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regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics used for diagnosing Germline Diseases (Draft Guidance)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

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