Cytyc Corporation of Marlborough, Massachusetts designs, develops, manufactures, and markets sample preparation systems for medical diagnostics, and other products for women's health.
The ThinPrep® Pap Test® is a new method for the automated preparation of microscopic slides for cervical cell samples, intended to replace the conventional PAP smear for cervical cancer screening. Founded in 1987, Cytyc has dedicated its scientific expertise and resources to developing the ThinPrep® System to address the limitations of the 50-year-old conventional PAP smear method.
Cervical cancer is one of the most common cancers among women. Cervical cancer is a disease that progresses through pre-cancerous and cancerous stages over a number of years. More importantly, cervical cancer is virtually 100% curable if it is detected and treated appropriately in the earlier stages of progression. Conversely, the cost of treatment increases significantly if cervical disease is discovered at later stages.
Since its introduction over fifty years ago, the cervico-vaginal Papanicolaou (PAP) smear has been a powerful tool for detecting cancerous and precancerous cervical lesions. During that time, the PAP smear has been credited with reducing mortality from cervical cancer by as much as 70%. This once precipitous drop in the death rate has slowed however, and the mortality rate in the USA for this preventable disease has remained virtually constant, at about 5,000 per year since the mid-eighties. Therefore, about one-third of the 15,000 women diagnosed with cervical cancer annually still die because the cancer was detected too late. A further cause for concern is National Cancer Institute data that shows an annual 3% increase in the incidence of invasive cervical cancer in white women under 50 years of age since 1986.
A number of factors may be contributing to this current threshold, not the least of which is the fact that many women, particularly in high risk populations, are still not participating in routine cervical cancer screening. Another contributing factor that has received much attention is the limitation of the traditional PAP smear method itself.
The reliability and efficacy of a cervical screening method is measured by its ability to diagnose precancerous lesions (sensitivity) while at the same time avoiding False Positive (false alarm) diagnosis (specificity). In turn, these criteria are dependent on the accuracy of the cytological interpretation. The conventional PAP smear has False Negative (error) rates ranging to more than 50%. Up to 90% of those False Negatives are due to limitations of sampling or slide preparation. Accurate interpretation of conventional PAP smears are compromised by the presence of blood, mucous, obscuring inflammation, scant cellular material and air-drying artifact.
In order to address these problems, Cytyc Corporation has developed the ThinPrep® Pap Test®.
The Food and Drug Administration (FDA) approved the ThinPrep® Pap Test® as a replacement for the conventional PAP smear in May 1996 On November 6, 1996, the FDA approved labeling allowing Cytyc to claim that:
By reducing the number of sub-optimal or "satisfactory but limited by" (SBLB) slides by as much as 50%, the number of return visits and repeat PAP smears is diminished. The significant improvement in specimen quality will substantially reduce costs and patient anxiety associated with re-screening and unnecessary follow-up testing.
The heart of ThinPrep® System is the ThinPrep® 2000 Processor, an automated slide preparation unit that produces uniform thin-layer slides, virtually free of obscuring artifacts such as blood, mucous, and inflammation.
Specimens are first collected by the clinician with a cervical sampling device. Then, instead of smearing the cells on a slide, the device is rinsed into a ThinPrep® vial containing PreservCyt® transport medium. The vial is then labeled and sent to the lab for processing.
At the laboratory, the vial is placed into the ThinPrep® 2000 Processor. First, a gentle dispersion step breaks up blood, mucous, and non-diagnostic debris; and then thoroughly mixes the sample.
A negative pressure pulse is generated which draws fluid though a TransCyt® Filter that collects a thin, even layer of diagnostic cellular material. The ThinPrep® 2000 Processor constantly monitors the rate of flow through the TransCyt® Filter during the collection process to prevent the cellular presentation from being too scant or too dense.
The cellular material is then transferred to a glass slide and fixed. ThinPrep® slides are stained and then evaluated by laboratory personnel using criteria similar to the conventional smear. What is different is the marked improvement in clarity and specimen adequacy achieved with the ThinPrep® System.
Cytyc Corporation is committed to the development of innovative products that will improve the quality of diagnosis, help prevent the development of disease through early detection, and reduce health care costs. To fulfill this commitment, Cytyc has established the ThinPrep® Pap Test® as the standard of care for the collection, preservation and slide preparation of cervical cell specimens. Click here to visit their web site.
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Cytyc®, Cytyc logo, ThinPrep®, ThinPrep® Pap Test®, TransCyt®, EnhanCyt®, CytoLyt®, C and Design®, Multi-Mix®, and PreservCyt® are some of the registered trademarks of Cytyc Corporation.