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2016, November, Memo FDA Approval for SurePath with the Cobas HPV Test

Reference Number: AA-00490


Important Memo

To:

All Providers

From:

Richard Riemersma, MD, Medical Director

Date:

November 10, 2016

Effective Date:

December 1, 2016

Re:

FDA approval for SurePath™ with the Cobas® HPV Test

 

Dahl-Chase Diagnostic Services is pleased to announce that SurePath™ Preservative Fluid is now FDA approved as medium for use with the cobas HPV Test for ASC-US reflex and co-testing.

 

The FDA based its approval of the Roche cobas HPV Test with SurePath Preservative Fluid on a clinical study of 952 eligible women 21 years and older with abnormal Pap test results. The Roche cobas HPV Test with SurePath Preservative Fluid demonstrated similar clinical performance when compared to a previously approved collection medium for cervical samples.

 

The cobas® HPV test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization.  The test specifically identifies high-risk genotypes HPV16 and HPV18 while concurrently detecting "other" high risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

 

The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using a cervical broom and placed in SurePath™ Preservative Fluid.  Specimens collected in SurePath vials with the brush and spatula are not FDA approved or validated unless they are used in addition to the cervical broom.  Therefore, we recommend that you use the cervical broom on all patients, but you may choose to use the brush and/or spatula in addition to the broom if you do not feel that an adequate specimen was obtained with the cervical broom alone.

 

 


Technical Information Contact:                       Scientific Information Contact:            Collection Contact:

Andrea Illingworth, MS, H (ASCP) QCYM     Mayur Movalia, M.D.                          Lisa Grant

(207) 941-8280                                               (207) 941-8200                                   (207) 561-2415