The Competition
There is no available screening product that adequately diagnoses tissue as part of an initial examination. Diagnostic testing is limited to colposcopy
and laboratory-based tissue analysis. In high income countries, there is no alternative screening product to the Pap test. Direct visual inspection or aided visual inspection of the cervix treated with acetic acid or Lugol’s solution has been found to be inadequate in low income countries and would lead to overtreatment if used by itself.
A device that uses random limited probing of the cervix with electrical and optical stimulus-response was manufactured by an Australian company and was available in European markets from 2001-2010 for use in conjunction with the Pap test. Both their hardware and their disposable component were expensive to build and the product performance was about the same as the Pap test. No mapping of the cervix was possible because location information was not provided by the product. No direct feedback was provided to the operator regarding probing technique and thus the accuracy of the product varied with operator proficiency. This device was never engineered to probe the canal. The company was liquidated in 2010.
Other systems are approved or under development for a diagnostic examination using optical testing of the cervix. This technology requires expensive equipment with special maintenance requirements and may ultimately be available to hospitals and follow-on clinics. In a 2005 medical review article of such devices, none of the devices under development were designed to test the cervical canal, which is required by the FDA for a screening device to replace the Pap test.
The chemical detection of biological markers that identify abnormal conditions is under investigation by research companies. As with the Pap test, this approach suffers from the limitation that the collection technique is not controlled for thoroughness. Obtaining samples from the canal also faces the same difficulties as the Pap test. In addition, the location on the cervix of the collected sample is unknown. At the current stage of development, this
type of testing could be used with the Pap test to improve screening tests.
