Untangling a New Breast Cancer Screening Technology

Fermiscan Holdings, a start-up firm in Sydney, Australia, says it plans to commercialize a ­controversial breast-cancer-screening ­technology that most scientists have given up on. The technology would replace traditional Xâ''ray mammography with a test requiring just a hair sample—and access to a multimillion-dollar particle accelerator called a synchrotron. Fermiscan is betting that women will greatly prefer offering a hair sample to suffering the discomfort of mammography. Having analyzed 800 hair samples collected from women as they go in for routine breast exams, Fermiscan says it will be ready to start offering screenings by the end of 2008. The trouble is, eight years after the technique was first reported, no independent laboratory has ever been able to make it work.

Fermiscan’s test is based on technology licensed from Veronica James, a physics professor at the Australian National University in Canberra, who reported in 1999 that she could detect an abnormality in the hair of women with breast cancer. In her research, James shot a concentrated beam of Xâ''rays at single strands of hair. When the beam hit the hair, the diffracted Xâ''rays formed a pattern on the detector related to the molecular structure of keratin, a protein found in hair. James claimed to find a diffuse additional ring in the diffraction pattern from hair samples of women with breast cancer.

After she published her results, many women were eager to ditch the discomfort of their yearly ­mammograms. ”All the women who were at our breast-cancer clinic were saying: ’Don’t give me any of these tests. Here’s some of my hair,’ ” says Keith Rogers, a ­medical-­imaging expert and professor of materials science at Cranfield University, in Swindon, England. He was one of the first to try to reproduce James’s work. When Rogers failed to find the same ­diffraction pattern, James publicly rejected his results, claiming that Rogers had not properly followed her methodology. James, who ­formerly consulted for Fermiscan, declined to comment for this article.

At least seven research groups, including one with which James briefly collaborated, have now tried and failed to ­reproduce her results. ”Some very eminent people have tried to reproduce it,” says Rogers. ”The ­irritating thing is I so much want to believe her, but I can’t find the proper evidence.”

Halfway through its recent trial, Fermiscan claimed that hair analysis has an 82 ­percent probability of detecting breast cancer in a person who has the disease, nearly matching the best results from mammography trials. However, hair analysis has only a 77 percent chance of correctly confirming that people without the disease really don’t have it, making the test less reliable than some mammography trials.

If it succeeds, Fermiscan could wedge itself into a lucrative market. About 1 million mammo­grams were conducted in 2007 in the United States alone, ­according to the U.S. Food and Drug Administration. Companies such as GE, Hologic, and Siemens are encouraging clinics to upgrade and purchase ­digital and three-­dimensional Xâ''ray mammography machines at a cost of hundreds of thousands of dollars per unit.

The Fermiscan test will cost the consumer about US $200 per sample, says David Young, Fermiscan’s managing director. That’s more than the $50 to $150 it costs for a mammogram in the United States, but with Fermiscan the clinic wouldn’t need to purchase and maintain its own imager. The Fermiscan test should take just 24 hours to complete, including the time it takes to ship the hair to the Advanced Photon Source at Argonne National Laboratory, in Illinois, where Fermiscan has its tests done. Young says that the company will first ­market its services in Southeast Asia, through a joint ­venture with regional health-care provider Avia Reed International, in Singapore.

Although most scientists in the field have given up on the technique, some remain hopeful that it will work. ”I wish [them] really well because it would be bloody wonderful if it worked,” says Rogers.