Hologic (HOLX) Gets FDA Approval of Genotype Assay
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Hologic, Inc. (NASDAQ: HOLX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's APTIMA HPV 16 18/45 Genotype Assay for use on its TIGRIS instrument system.
Hologic's APTIMA HPV 16 18/45 Genotype Assay is the first test FDA-approved for genotyping human papillomavirus (HPV) types 16, 18 and/or 45, which are associated with approximately 80% of all invasive cervical cancers worldwide. Detecting these HPV types provides health care professionals with more information regarding a patient's risk of subsequently developing cervical cancer.
The Company expects to begin commercialization of the APTIMA HPV 16 18/45 Genotype Assay during the first quarter of fiscal 2013.
Hologic's APTIMA HPV 16 18/45 Genotype Assay is the first test FDA-approved for genotyping human papillomavirus (HPV) types 16, 18 and/or 45, which are associated with approximately 80% of all invasive cervical cancers worldwide. Detecting these HPV types provides health care professionals with more information regarding a patient's risk of subsequently developing cervical cancer.
The Company expects to begin commercialization of the APTIMA HPV 16 18/45 Genotype Assay during the first quarter of fiscal 2013.
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