FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test
“Today, the U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C. The test may be performed in settings operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments and urgent care clinics. Rather than requiring a sample to be sent to a central lab for testing, the test detects HCV RNA and delivers results in about an hour using a blood sample from the fingertip.”
Court Mostly Upholds Coverage of PrEP and Preventive Health Care, for Now
“Following a federal appeals court decision it deemed “something of a mixed bag,” most health insurers must continue to cover certain preventive services and their related costs, including pre-exposure prophylaxis (PrEP) to prevent HIV along with screenings for cancer. However, the court ruled against the system that decides which procedures must be covered, declaring that the agency behind the health coverage requirement operates unconstitutionally.”
Concerns after Philly’s new budget slashes funding for syringe exchange programs
“PHILADELPHIA (WPVI) — Some members of the medical community have serious concerns after Philadelphia’s new budget slashed funding for syringe exchange programs. The CDC warned lack of such programs could eventually cause an outbreak, as detailed in a letter sent last month to Philadelphia physician Ronald Collman. The agency called “syringe service programs,” or SSPs, are a “vital part of basic public health infrastructure,” in that they prevent the spread of diseases like HIV and Hepatitis C. Earlier this month, the city passed a budget that stopped paying for syringe services with tax dollars, specifically about $1 million was cut from Philadelphia nonprofit Prevention Point.”
Integrating HCV screening with breast cancer programs enhances care
“Findings from a recent study suggest incorporating hepatitis C virus (HCV) screening into breast cancer screening programs may offer a viable strategy for improving engagement with the care cascade and linkage to direct-acting antiviral (DAA) treatment among older female patients.”
LA County Calls for Enhanced Efforts on Hepatitis C Testing, Treatments
“The Board of Supervisors directed its Departments of Public Health and Health Services Tuesday to provide Hepatitis C testing to patients in primary care settings, including pregnant women and other people considered at high risk.”
