LEXINGTON, Mass., Oct. 11 -- Medical device company MediSpectra Inc. said it has begun enrolling patients in a major clinical study of its cervical imaging system, Luma, at thirteen sites in the US. The study of 2200 women with abnormal Pap smears will compare the performance of Luma as an adjunct to colposcopy (the current method for evaluating Pap smear results) to colposcopy alone.
In a 12-second optical scan, Luma collects biochemical and cellular characteristics from a patient's cervical tissue. Areas of the cervix with high-grade precancerous lesions are then identified and displayed on a color video image. The clinician uses the image of high-grade disease areas in combination with colposcopy to select locations to biopsy.
In a preceding 604-patient pilot study conducted at six medical centers, an analysis of the data suggested Luma can detect 31 percent more high-grade precancerous lesions than colposcopy, MediSpectra said.
MediSpectra recently completed a $13 million round in venture capital investment, bringing the total amount raised to $55 million. The company said it anticipates submitting the clinical trial results to the US Food and Drug Administration for product approval.
For more information, visit: www.medispectra.com