The China Food and Drug Administration approved the CINtec PLUS Cytology test, developed by Roche, for identifying women with cervical pre-cancer. A multi-center study of five participating hospitals throughout China revealed greater overall performance of combined sensitivity and specificity of the CINtec PLUS Cytology test in determining which women are at higher risk of developing... […]
FDA approved Xalkori (crizotinib) to treat people with metastatic non-small cell lung cancer whose tumors have an ROS-1 gene alteration. Xalkori, sponsored by Pfizer, is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC. FDA previously granted the Xalkori expanded use application breakthrough therapy designation and priority review status.
Regulatory authorities in six countries have granted 10 sales authorizations for Yondelis. Five of those authorizations are for Yondelis (trabectedin) in combination with Caelyx (pegylated liposomal doxorubicin) for treating relapsed platinum-sensitive ovarian cancer, in Bangladesh, Costa Rica, Kuwait, Moldavia and Saudi Arabia The other five authorizations are for Yondelis for soft tissue sarcoma, in Bangladesh,... […]
FDA approved the American College of Radiology’s alternative standard request to allow mammography facilities to use the new Digital Mammography Quality Control Manual and Digital Mammography QC Phantom in routine QC of digital equipment. The new manual and phantom will aid in ensuring uniformity of QC testing, the ACR said. The FDA alternative standard specifies... […]
SADIK ESENER will direct the Center for Early Detection Research at Oregon Health and Science University's Knight Cancer Institute. Esener will also hold the Wendt Family Endowed Chair in Early Cancer Detection.
In California, nearly 75 percent of the state's hospitals performed only one or two surgeries when treating one of 11 selected cancer types in 2014, according to a report from the California Health Care Foundation.
Veritas Genetics introduced Veritas myGenome, a whole genome sequencing platform for less than $1,000, including interpretation and genetic counseling. The platform includes a digital report and app to interact with results, on-demand additional genetic counseling via video conferencing, and lifestyle-relevant genetic information that can be shared with non-clinical service providers such as fitness coaches and... […]
Companies that provide 90 percent of electronic health records used by U.S. health care organizations have agreed to improve the flow of health information for consumers and health care providers, HHS officials said.
The National Academy of Medicine listed 10 goals for advancing the appropriate use of biomarker tests in precision medicine.
Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?
