Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its FACSPresto system and CD4/Hb cartridge designed as an HIV/AIDS diagnostic.
The Franklin Lakes, N.J.-based company’s system is designed as an automated multicolor fluorescent imaging cytometer and absorbance spectrometer, providing absolute and percentage results of CD4 T lymphocyte and hemoglobin concentration in blood samples.
“This FDA 510(k) clearance aligns with BD’s purpose of advancing the world of health. We believe our BD FACSPresto system provides superior ability to accurately monitor patients living with HIV/AIDS in a variety of health care settings at a reasonable cost, which ultimately may help control the spread of the disease,” BD biosciences worldwide prez Claude Dartiguelongue said in a prepared statement.
The device uses a proprietary dried reagent cartridge which BD says increases stability across varied storage conditions. The system also includes a touch screen and allows for the processing of 80 tests in a day, with results available in less than 4 minutes.
BD said that results from clinical studies of the device reported it performing comparably with traditional analyzers.
Earlier this month, BD beat the consensus estimate for its fiscal 1st-quarter earnings, backed by top-line growth of nearly 46%.
Franklin Lakes, N.J.-based BD posted profits of $229 million, or $1.06 per share, on sales of $2.99 billion for the 3 months ended Dec. 31, 2015. Although that’s a 45.6% sales gain compared with the same period in 2014, it’s a -3.0% bottom-line decline.
Adjusted to exclude 1-time items, however, earnings per share reached $1.96 apiece, a full 12¢ ahead of analysts on Wall Street, who were looking for sales of $3.03 billion.