Lifeline BioTechnologies develops breast cancer detection system

Nonimaging device to be used for younger women

A new breast cancer detection firm has appeared on the mammography scene. Lifeline BioTechnologies of Reno, NV, this month revealed details of a new early-detection breast cancer system called First Warning that the company hopes can be used to screen women considered too young for x-ray mammography.

The technology is based on the belief that temperature changes in the breast can be an indicator of pathology. While other companies are developing systems that also measure breast temperature changes, Lifeline’s system is unique in that it measures such changes over a 24-hour period rather than at one point in time.

First Warning consists of a monitor that attaches to a woman’s clothing and a set of leads that are placed in strategic areas around the breast. The monitor is similar to a Holter monitor, but it collects data on minute temperature changes on the surface of the breast rather than from electrical activity of the heart, according to the company.

The woman wears the monitor for 24 to 36 hours, and, at the end of the period, the data are collected and fed into a central computer by inserting the monitor into a docking port. The data are then analyzed using neural network algorithms, which Lifeline believes can uncover pathology by revealing changes in the circadian (24-hour) rhythms of breast temperatures.

Lifeline is not the only company to explore temperature measurement to detect breast pathology. Scantek of Denville, NJ, has developed BreastAlert Differential Temperature Sensor, which uses heat-sensitive pads placed on each breast to measure breast tissue temperature. Scantek has licensed the technology to HumaScan of Cranford, NJ (SCAN 6/10/98).

Lifeline executives claim First Warning is different from products like Scantek’s BreastAlert because it measures temperature changes over a longer period of time, rather than relying on a static test.

“Temperature for temperature’s sake is not significant. It’s the movement of the temperature over time that gives us a more significant picture,” said William Reeves, Lifeline’s founder. “Our analysis is based purely on pathology—the neural net information is based on cancers that are proven where we have a temperature profile.”

First Warning’s monitor takes the temperature of the breast every five minutes, producing more than 9000 pieces of physiological data by the end of the test period. The company has conducted studies to assess the effect of other factors on the First Warning system, such as hormonal changes and external temperature increases. The firm claims that with the system’s specific algorithms, these types of data do not override the temperatures the device is intended to track.

Lifeline is pursuing a clinical trial with the device and plans to submit an application to the FDA in order to be able to make marketing claims for the detection of breast cancer. The company hopes to file an application next year and expects to offer First Warning with either buy or lease options to hospitals with well-established breast-cancer screening programs. Hospitals would then make the technology available to primary-care physicians, Reeves said.

The company does not intend to position First Warning as a competitor to mammography screening, according to Reeves. Instead, Lifeline sees its technology as an important initial screening exam for younger women, who typically are not recommended for screening mammography.

“There’s a big difference between pre- and post-menopausal cancer,” Reeves said. “Cancer is not an event, it’s a process. The empirical data would indicate that the milieu for breast cancer is the early childbearing years—and if you have a technology where you can screen women (at this time), you’re way ahead of the game.”

In addition to its First Warning system, the company has a subsidiary, Nature’s Creation, that develops nontoxic supplements intended to treat early cancer with compounds such as isoflavins, which are soy derivatives of soy germ.