Digene Rapid Capture
This article was originally published in The Gray Sheet
Executive Summary
PMA supplement for high-volume sample throughput instrument is submitted to FDA for use with the firm's DNAwithPap HPV test. The system incorporates automated pipetting and microplate processing to analyze over 350 patient samples in an eight-hour lab shift, Digene claims...
You may also be interested in...
Digene Rapid Capture
High-volume sample throughput instrument gains PMA supplement approval for use with the firm's HC2 HPV DNA test, also marketed as DNAwithPap for primary human papillomavirus screening in conjunction with Pap smear. The system incorporates automated pipetting and microplate processing to analyze 352 patient samples in a 6.5-hour lab shift, and is expected to facilitate DNAwithPap adoption by large labs, Digene says (1"The Gray Sheet" Nov. 10, 2003, In Brief). Rapid Capture previously was cleared for use with Digene chlamydia and gonorrhea tests. HPV sales drove Digene revenue up 39% to $23.6 mil. for its fiscal third quarter (ended March 31)...
Japan Regulatory Update: Revised Law Widens RWD Scope, Price Revisions/Listings
Japan now allows pseudonymized personal data for medical use under a licensing system for wider use of real-world data. Meanwhile, a national cost-effectiveness assessment scheme has slashed reimbursement prices for Lagevrio and Kerendia, and Alexion’s Voydeya has been added to the reimbursement tariff.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.