FDA approves Roche’s COBAS HPV Test for use with SurePath Preservative Fluid.

  

The SurePath kit for collecting and transporting the cervical specimens.  

Clinical pearls:

• HPV testing can now be performed on samples collected for liquid based pap test in the BD SurePath preservation fluid using the SurePath vial. 
• Before the approval, healthcare providers have to collect two different samples in two different collecting fluids according to the specification of the testing labs.
• It is not approved as a first line primary screening test.

The U.S. FDA today approved the Roche COBAS test as the first test for Human Papilloma Virus(HPV) from cervical samples collected for Pap Test in BD SurePath Preservative fluid.[1]

COBAS HPV test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis.

BD SurePath is a liquid based pap test and the test pack includes collection kit, along with storage and transportation components with a vial of preservative liquid.

Some other properties of BD SurePath liquid-based Pap test are ease of transportation, have less than 24% Ethanol which results in immediate and complete cell fixation, preserving the morphology. It also has the ability to preserve the sample for 4 weeks at room temperature, 6 weeks refrigerated.[2]    

The kit comes with specific instructions on how to collect samples to minimize the risks of false negative results.

Till date FDA has not approved any HPV test that can be used with the preservation liquids. Healthcare providers have to collect two different samples, in two different collecting fluids before the announcement was made.

Now, a single sample collected can be used for carrying out both the tests. The test has been approved in women 21 years and more, and helps to determine additional follow-up and diagnostic procedures after ASC-US (Atypical Squamous Cells of Undetermined Significance) Pap cytology results. It has also been approved for use is patients 30 years and older as a primary screening test for HPV along with pap cytology. It detects 14 high-risk HPV types, including HPV 16 and 18, which are responsible for causing 70% of cervical cancer worldwide.

According to the National Cancer Institute, there will be an estimated 12,990 new cases and 4,120 deaths from cervical cancer in the United States during 2016.[3]

"Many labs have a preference in how samples are collected for processing, and this additional approval gives them another clinically validated option for the Cobas HPV test," Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement.

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[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510251.htm

[2] http://www.bd.com/tripath/products/outside_us/outside_us_sp.asp

[3] http://www.cancer.gov/types/cervical/hp