Tuesday, November 22, 2005

The Halo Breast Pap Test System

Filed under: Ob/Gyn , Surgery

Here is something completely different for the identification of breast disease. The FDA has just approved a new Papanicolaou (Pap) test system, the Halo Breast Pap device from Irvine, California based NeoMatrix, LLC. The office based system collects nipple aspirate fluid (NAF) for a cytological evaluation. The collected fluid can be analysed for the presence of normal, premalignant, and malignant cells. From the company's press release:

Virtually all breast cancer (95 percent) originates in the ductal system of the breasts and progresses through identifiable stages of development. According to a recent article in the New England Journal of Medicine, benign breast disease - which can present as abnormal cells - is an important risk factor of breast cancer. This study joins a growing body of research that demonstrates that the cytological assessment of breast duct fluid, or Nipple Aspirate Fluid (NAF), can identify a woman's specific risk of breast cancer...

Using gentle suction like a breast pump, the HALO Breast Pap Test uses adjustable breast cups to collect NAF. During the 5-minute cycle, the HALO system generates mild compression on both breasts while simultaneously applying heat. Toward the end of the cycle, the HALO system initiates gentle suction to retrieve any fluid from the ducts.

Future studies will have to determine the place for this test among several screening tools for detecting early breast cancer (such as mammography and self-breast examination). Too early to predict.

The press release (.pdf)...

NeoMatrix website...

                (3)