Swiss investigators told the Conference on Retroviruses and Opportunistic Infections that about a quarter of the country's cases of acute hepatitis C may involve men who have sex with men from other countries. Researchers said the interconnectedness of Europe means increasing use of direct-acting antivirals will need to be carried out in joint initiatives.
A study showed that the cost-effectiveness ratio for Oncotype DX, a gene expression profile testing used for patients with early stage breast cancer, was $28,947 per quality adjusted life years with perfect test accuracy and $39,496 per QALY under ideal clinical trial conditions assuming 100% adherence to test-guided therapy, compared with usual care. Researchers note that their findings "underscore the importance of considering real-world implementation when assessing ... new technology."
The ZIKV-NS2B-concat ELISA assay is a blood test developed by Columbia University researchers that is capable of extending the interval of accurate detection of Zika infections from weeks to months after its onset, according to the journal mBio. The blood test can analyze up to 200 samples in four hours and was tested on blood samples of children who had previously tested positive for Zika virus in the Nicaraguan Pediatric Dengue Cohort Study.
Sunesis Pharmaceuticals has extended the timeline for its vecabrutinib dose-escalation study, which is evaluating the drug for adults with chronic lymphocytic leukemia and other B cell cancers. Sunesis will also increase the number of patients in the 50-mg group to six after one participant experienced adverse events and another patient's disease progressed, with results from the Phase Ib study expected to be ready this fall, according to interim CEO Dayton Misfeldt.
The FDA approved Oxford Immunotec's assays for Babesia microti antibodies in human plasma and DNA in whole blood samples from blood and organ donors. Babesia parasites transmitted by blacklegged or deer ticks cause 1,000 to 2,000 cases of babesiosis each year in the US, according to the FDA.
The FDA's Oncologic Drugs Advisory Committee has voted 8-4 in favor of the use of Amgen's Blincyto, or blinatumomab, as a treatment for patients with minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia. The supplemental biologics license application was backed by data from a midstage study, in which 69 of 116 patients in the study achieved a complete MRD response within the first cycle of blinatumomab treatment.
The FDA approved 23andMe's direct-to-consumer test for three BRCA gene mutations linked to breast cancer, but the agency warned that most other BRCA mutations associated with an elevated breast cancer risk are not covered by the test. "The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk," the FDA's Donald St. Pierre said.
CDC researchers identified 60 growing HIV transmission clusters based on an analysis of HIV nucleotide sequencing data from people diagnosed within the past three years. "Molecular surveillance is an advanced public health technology that we believe will enable state and local health departments to more quickly and efficiently identify where HIV transmission may be occurring and how to efficiently intervene to stop it," CDC epidemiologist Anne Marie France said.
A 10-patient pilot study in the Annals of Internal Medicine found the use of transplant kidneys from hepatitis C virus-positive donors to HCV-negative recipients did not result in any cases of transmission after three months. "Based on this initial pilot study, transplanting kidneys from HCV-positive organ donors into HCV-negative recipients while giving direct acting anti-viral medications appears to be a safe and effective way to expand the organ donor pool," said lead author Dr. Niraj Desai of Johns Hopkins University School of Medicine.