Hologic, Inc. (Hologic or the
Company) HOLX, a leading developer, manufacturer and supplier of
premium diagnostic products, medical imaging systems and surgical products,
with an emphasis on serving the healthcare needs of women, announced today
that the U.S. Food and Drug Administration (FDA) has approved the Aptima HPV
16 18/45 genotype assay for use on the Company's fully automated Panther
system. The Aptima HPV 16 18/45 genotype assay is performed using Hologic's
ThinPrep liquid cytology specimen and is intended to be tested from the same
sample that has already received Aptima HPV assay positive results.
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. Recent data
suggests that although cervical cancer incidence has decreased since the
1970s, the prevalence of adenocarcinoma cases has risen approximately 32
percent in the same time frame.^1 Detection of these HPV types as part of
reflex testing may help clinicians identify up to 94 percent of all cervical
adenocarcinomas.^2
Although HPV genotype 45 is fairly uncommon, identified in only 0.4 percent of
women with normal cytology, data indicates that it is the third most common
HPV genotype in invasive cancer. The addition of HPV genotype 45 is designed
to help identify more women at risk for adenocarcinoma, with minimal impact to
colposcopy rates. Studies have shown that HPV types 16, 18 and 45 are more
likely to be integrated into the human genome than are the other HPV types,
and tumors with these genotypes may present earlier.^2
"The addition of the Aptima HPV 16 18/45 genotype assay to the Panther menu
further extends the capability of low- to high-volume laboratories to run
multiple tests 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.
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