The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
The NAM, NAS, and Royal Society have formed a commission to develop a framework on the proper use of genome editing, and convened its first meeting in Washington, DC, this week.
The bipartisan bill aims to provide federal support to children who are ill from an unknown cause and could gain insights into diagnosis or treatment approaches via WGS.
H.R. 3235, a long time priority for the National Society of Genetic Counselors, would allow CMS to reimburse genetic counselors for counseling Medicare beneficiaries.
Two senators have asked a government watchdog to see if CMS made payments to US providers who have partnered with firms including WuXi NextCode and BGI.
The commission will develop a framework for scientists, clinicians, and regulatory authorities on the appropriate use of human germline genome editing.
The guidelines suggest researchers recontact participants when there is change in the interpretation of their genetic results that could affect medical management.
A statement from NIH Director Francis Collins follows a call by scientists for the moratorium pending the creation of a framework to guide the use of heritable genome editing.
The budget calls for $34.4 billion for the NIH in the coming fiscal year, including $492 million in resources made available through the 21st Century Cures Act.
CRISPR technology has made its way around the world, but in the wake of the He Jiankui controversy, the industry is asking what recourse it has against misuse.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
Even as He Jiankui expressed pride in the work he had done to alter the CCR5 genes of twin embryos, researchers and ethicists decried him as misguided.
At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.
