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The agency is also hosting a portal for submissions and inquiries as part of the newly created Medical Countermeasures Taskforce.

If granted, emergency use authorization is anticipated to help roll out standardized, consistent 2019-nCoV testing to public health labs in the US. 

Scheduled to go into effect next year, CMS' price transparency regulations could drive down reimbursements but also streamline billing for hospital labs.

The agency said it believes its recent focus on the issue has tamped down on genetic testing fraud, though it expects new questionable arrangements will emerge.

A pair of lawyers familiar with the case said that while ACLA might not win the legal battle, its lawsuit could aid efforts to get a legal fix to the law.

Under a contract with BARDA, First Light is developing a digital imaging-based diagnostics platform, as well as tests for anthrax and urinary tract infections.

The company's GSP Neonatal Creatine Kinase-MM kit measures the CK-MM protein and is the first test to help in newborn screening for Duchenne Muscular Dystrophy. 

The firm said that in a first phase of the contract it will focus on further development of its fever test that analyzes immune system gene expression patterns.

The firm is developing the test under a contract with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.

The company raised $7.4 million in an extended Series B financing round and entered a partnership with BARDA valued at $7.6 million.

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