federal legislation

Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.


The Canadian government is asking for the constitutionality of the country's new anti-genetic discrimination law to be assessed, Bloomberg BNA reports.

ACLA said the goal of the delay is to redefine "applicable laboratories" and give labs and CMS more time to collect data that will inform market-based pricing.

The US House of Representatives has passed the latest version of the 21st Century Cures Act.

The DTWG proposal for regulating in vitro clinical tests has made it into draft legislation but it still needs support from key stakeholders in the life sciences field.

The discussion document contains many proposals for modernizing the way drugs and medical devices are advanced, but legislators are conspicuously silent on diagnostic regulations, specifically LDTs. 

NEW YORK (GenomeWeb News) – A bipartisan bill has been introduced in the US House of Representatives that would provide a safe harbor for in vitro diagnostic test makers if their tests that are approved for research use only (RUO) are used by their customers in certain clinical settings.

NEW YORK (GenomeWeb News) – US Sen. Tammy Baldwin (D – Wis.) plans to introduce legislation aimed at helping provide opportunities for young scientific investigators amid a long-term trend of flagging federal research funding and the sequestration cuts

NEW YORK (GenomeWeb News) – A bipartisan pair of lawmakers in the US House of Representatives have introduced the Newborn Screening Saves Lives Reauthorization Act, which has several provisions to help guide and support disease-risk screening programs across the US.

This article has been updated to clarify comments from Anya Prince of the Cancer Legal Resource Center. The article inaccurately cited Prince as stating that some states mandate coverage for BRCA testing.

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Sometimes genetic tests give inconclusive results and provide little reassurance to patients, the Associated Press reports.

Vox wonders whether gene-editing crops will be viewed similarly as genetically modified organisms of if people will give them a try.

In Science this week: research regulation and reporting requirement reform, and more.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.