In researching Cytyc, I found this recent press release that bodes
well for company should they get FDA approval.
BOXBOROUGH, Mass., Oct. 4, 1996 -- Cytyc Corporation (Nasdaq: CYTC)
announced today that it has submitted a Premarket Approval Application
(PMA) supplement to the U.S. Food and Drug Administration (FDA)
to allow patients with inconclusive or borderline diagnoses of
cancerous cells to be tested for human papillomavirus (HPV)
directly from the single cervical sample collected to prepare
Cytyc's ThinPrep(R) Pap Test. The clinical study supporting Cytyc's
PMA supplement demonstrated thatthe collection method for the
ThinPrep Pap Test was equivalent to the collection method for
Digene Corporation's Hybrid Capture Assay for HPV. Digene's
Hybrid Capture Assay is the only FDA approved test for HPV.
"The ability to conduct HPV typing immediately following an
inconclusive or equivocal Pap test result should provide
doctors with a much clearer indication of how to best manage
these women," said Michael Adams, Vice President of Regulatory
Affairs at Cytyc. Digene's test enable clinicians to, in
effect, classify inconclusive cervical specimens as either
normal or abnormal. Cytyc's test allows this additional diagnostic
capability from a single cervical sample, eliminating the need to
call the patient back for an additional office visit. The
combination of these two technologies could allow cost-effective
identification of the small number of women with abnormalities of
the cervix who require careful and aggressive management.
Healthcare system cost savings could result from this combined
approach by eliminating unnecessary medical intervention.
Currently, inconclusive or borderline results with Pap smears
create the need for additional testing and patient care, costing
the U.S. healthcare system $3.6 billion annually according to
estimates from the National Cancer Institute (NCI). Each year in
the United States, approximately 3.5 million Pap smears are
classified as inconclusive. Many women whose Pap smears are diagnosed
as inconclusive are called back for additional testing or are treated
as if they have a cervical abnormality even though only an estimated
30 percent of these women actually have cervical disease.
Consequently, women with inconclusive Pap smears often undergo
unnecessary colposcopy, biopsy, and office visits."We're pleased with
these clinical trial results," said Mr. Adams. "They demonstrated
the utility of testing for HPV with Digene's Hybrid Capture Assay,
using the cervical specimen collected with Cytyc's ThinPrep collection
technology." Conducted at Grady Memorial Hospital in Atlanta, the
trial confirms the original proposal calling for a single cervical
specimen to be obtained from a woman during her annual gynecologic
office visit and collected in Cytyc's preservative fluid. At the
laboratory, Cytyc's ThinPrep PapTest would be performed to identify
negative and positive cases of cervical abnormality. If, on the other
hand, the diagnosis is inconclusive, Digene's Hybrid Capture Assay
would be performed using the original cervical specimen to detect
the presence of high-risk cancer-causing types of HPV without calling
the woman back to the physician's office. Only those patients testing
positive for cancer-causing types of HPV would undergo colposcopy,
biopsy, and, when necessary, surgical procedure. According to Adams,
"The ability to perform two tests from one sample taken in a single
office visit enhances the value of the ThinPrep Pap Test and potential
ly offers cost savings to the healthcare industry by reducing unnecessary
procedures."
The economic impact of the combination approach is being evaluated in
two independent clinical trials. The first, sponsored by Kaiser
Permanente Division of Research in Northern California, seeks to
quantify the cost savings of new treatment guidelines for patients.
A second, larger project organized by the NCI has a similar objective
of improving the quality of patient management while reducing overall
costs and incorporates both Cytyc's ThinPrep Pap Test and Digene's
Hybrid Capture Assay.
Cytyc Corporation develops, manufactures and markets the ThinPrep System for medical diagnostic
applications. The ThinPrep System consists of the ThinPrep 2000 Processor and related reagents, filters
and other supplies. Cytyc received FDA clearance on May 20, 1996 to use the ThinPrep System as a
replacement for the conventional Pap smear. Cytyc Corporation has marketed ThinPrep since 1991 for
use in the diagnosis of cancers including cancers of the lung, bladder and gastrointestinal tract and in the
preparation of fine needle aspiration of thyroid and breast tissue. Cytyc's headquarters, research,
development and manufacturing facilities are located in Boxborough, Mass. Cytyc(R) and ThinPrep(R) are
registered trademarks of Cytyc Corporation. All other trademarks used herein are property of their
respective owners. |
