Labroots

Finally, an HPV test cleared for use with SurePath

It may seem like just yesterday, OK it was around 1997, when an HPV (human papillomavirus) test was approved for use by the FDA with a specific media— ThinPrep—as an important triage test for women ...
Cure Today

HPV Test Used With SurePath Preservative Fluid Gains FDA Approval

Roche cobas HPV Test gained U.S. Food and Drug Administration (FDA) approval for the use with SurePath Preservative Fluid to detect human papilloma virus (HPV) in cervical cells. SurePath is one of ...
USA Today

False-negative results found in HPV testing

Labs have been using test kit that is approved for Pap test%2C but not HPV testing FDA issued warning June 8 that using SurePath can produce false negative results Many gynecologists unaware of ...
Monthly Prescribing Reference

First HPV Test for Use With SurePath Preservative Fluid Gets FDA Approval

microscope Roche announced that the Food and Drug Administration (FDA) has approved the cobas HPV Test, making it the first test for Human Papilloma Virus (HPV) that can be used with cervical cells ...
USA Today

FDA to scrutinize HPV test linked to false readings

FDA issued warning June 8%2C 2012%2C that using SurePath can produce false negative results Many gynecologists unaware of warning or issue with SurePath SurePath accounts for about 30%25 of the ...
Nasdaq

BD Onclarity™ HPV Assay Receives FDA Approval for Use with Both BD SurePath™ Liquid-based Pap Test and Hologic ThinPrep® Pap Test

FRANKLIN LAKES, N.J., Feb. 21, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) ...
Nature

Cervical histology after routine ThinPrep or SurePath liquid-based cytology and computer-assisted reading in Denmark

We compared the sensitivity and specificity of liquid-based cytology (LBC) and computer-assisted reading for SurePath/FocalPoint and ThinPrep with those of manually read conventional cytology in ...
clinicaladvisor.com

FDA approves new HPV test

The Roche cobas HPV Test has been approved by the FDA. A new HPV screening test that uses cervical cells collected for a Pap test has been approved by the FDA. The FDA has approved the Roche cobas HPV ...
Medindia

Roche's cobas HPV Test receives FDA approval for first-line cervical cancer screening using SurePath preservative fluid

TUCSON, Ariz., July 30, 2018 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) approval for the cobas ® HPV Test to be ...
Pharmabiz

Indira IVF, BD SurePath join hands to advance cervical cancer screening in India

In a significant move to enhance cervical cancer screening accuracy and accessibility in India, Indira IVF collaborates with BD SurePath. This partnership is aimed at helping improve patient care in ...
WLTX19

False-Negative Results Found in HPV Testing

that the Food and Drug Administration has not approved for detecting the human papillomavirus, or HPV, which causes nearly all cervical cancers. Some of the largest national labs have for a decade ...