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FDA Approves Aptima HPV 16 18/45 Genotype Assay for Use on Hologic's Panther System
Date:11/7/2013

ts from a single specimen, on a cost-effective, highly flexible and fully automated molecular testing platform," said Rohan Hastie, Ph.D., Hologic's Group Vice President – Diagnostics.

The Aptima HPV 16 18/45 genotype assay is intended to test specimens from women with Aptima HPV assay positive results.  The FDA has approved the test for two uses:

  1. In patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
  2. In patients 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

The Aptima HPV 16 18/45 genotype assay was CE marked in December 2011 and received FDA approval on the Hologic high-throughput Tigris system in October 2012.

For more information about Hologic's molecular diagnostic technology, please visit www.hologic.com or www.gen-probe.com.

About Hologic, Inc.:Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical
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SOURCE Hologic, Inc.
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