Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.
The Centers for Medicare & Medicaid Services announced it would cover approved CAR-T therapies for Medicare patients, according to the Associated Press.
The company attributed the revenue decline to a 96 percent drop in licensing revenues, which more than offset a 36 percent increase in product sales.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
The Irish Times reports that US lawmakers and law enforcement agencies are concerned about ties between the US and Chinese genomics firms.
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.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.
The ctDNA test will be covered for all US fee-for-service Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.
The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.
In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.
MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.
In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.