Sign In
Free Newsletter
A Kinder, Gentler Mammography Machine
Listen to this articleCan red light zap the scalpel and the X-ray machine?
DOBI Medical Systems of Mahwah is betting it can. If the startup company is right, it could mark a revolutionary change in how breast cancer is diagnosed and treated.
In particular, it could sharply reduce the number of women-2.5 million on average in the U.S.-who are referred each year for surgical biopsies of suspect breast tissue.
DOBI (the name stands for Dynamic Optical Breast Imaging) is seeking approval from the U.S. Food & Drug Administration to use its ComfortScan machine to diagnose breast cancer.
The machine is based on body-measurement research first done at Russia”s National Academy of Sciences. It beams red light through the breast and onto a sensitive digital camera that uses a set of proprietary algorithms to create high-resolution images of tissue.
The device emits no radiation and, says the company, is a far more comfortable procedure for women to undergo than conventional X-ray mammograms. Six prototypes are currently being tested in hospital settings.
If it gets to market, experts say the DOBI machine could supplant biopsies as a conclusive way of determining whether a growth is malignant, and it could also serve as an important adjunct to X-rays, particularly in screening younger women for breast cancer.
The DOBI machine is on the cutting edge of cancer-fighting strategies because it is designed to detect angiogenesis, the webs of new blood vessels that cancerous tumors spin to nourish themselves.
Dr. William Li, president of the Angiogenesis Foundation in Cambridge, Massachusetts, says the DOBI machine is one of the most promising of a new generation of imaging systems aimed at spotting these telltale vascular systems.
“It could advance the detection and treatment of breast cancer not in an incremental step, but in a monumental leap,” he says.
The new detection technologies, he says, are coming along at the same time that research into drugs to block the formation of circulatory systems for tumors is surging, with 300 companies working on anti-angiogenesis drugs and 80 firms in clinical trials.
“You”re talking about a revolutionary breakthrough treatment and a revolutionary imaging system,” he says.
As debate flares in medical circles over whether mammograms boost cancer-survival rates and at what age women should be urged to undergo them annually, the DOBI machine could provide some fresh choices and answers.
“X-ray has been around since 1895 or so and some people have asked, why are we still using a 100-year-old technology,” says Phillip Thomas, CEO of DOBI Medical Systems.
One reason, Thomas says, was until recently there was no other diagnostic tool for looking inside the breast. So women have continued to rely on conventional X-ray mammograms, despite the discomfort from breast compression and the exposure to radiation that comes with them.
And while X-rays can pinpoint an area of suspect tissue, they generally can”t determine whether a growth is malignant or benign. Even if a growth appears to be benign, no doctor wants to take the risk of missing a case of cancer. Hence the millions of needle and surgical biopsies each year, at a cost of up to several thousand dollars each, with the attendant medical risks and scarring. Only 20% of such biopsies confirm the presence of a malignancy.
The DOBI machines would cost $140,000 to buy, a bit more than conventional X-ray mammography machines but less than the latest digital versions, which can cost from $400,000 to $600,000.
On a per-use basis, DOBI would also cost more than conventional X-rays-about $200 to $300 per use compared with $75 to $150 for X-rays. But Thomas says the DOBI scans can save money by eliminating unnecessary biopsies. Says he: “There is a definite medical economics case to be made.”The company has already tested its machine on 1,400 women and cleared three of the five phases of the FDA approval process for medical devices, and DOBI expects to file its final block of clinical data sometime next year. It has begun to raise $10 million to $15 million in additional capital to see it through the rest of the FDA approval process.
“I think it”s a very exciting approach,” says Dr. Richard Davies, chairman of the surgery department at Hackensack University Medical Center, who has been studying the use of the DOBI machine on patients since 1998. He says women who have tried the DOBI machine “like it more than mammography because it doesn”t involve the compression.”
According to Li, the light pressure the DOBI machine exerts on a breast is comparable to the effect of putting on a sports bra.
DOBI Medical Systems claims its machine exerts only a half pound of pressure on the breast compared with 38 pounds for a conventional X-ray machine.
Davies says one of the most promising uses of the DOBI machine could be to detect possible malignancies in premenopausal women whose denser breast structure can block X-rays.
He says the machine can also be useful as an intermediate step between an X-ray mammogram that shows an abnormality and a surgical biopsy. The DOBI scan, he says, can help confirm whether there are signs of malignancy that mean a biopsy is needed.
Davies thinks X-ray mammograms will still be “the mainstay of diagnosis,” but he foresees DOBI machines being used alongside them, particularly for hard to diagnose cases and for younger women with dense breasts.
If women in the U.S. and elsewhere benefit from the machine, they will have a group of Russian scientists and American capitalists to thank.
The technology on which the machine is based was developed in the early 1990s by Dr. Edward Girek, a Russian physicist, and colleagues at the National Academy of Sciences in Moscow.
After Girek published some of his findings in a technical journal in 1991, a group of venture capitalists from New York City took an interest and that led to the formation of Dynamics Imaging in 1994.
David Clarke, the chairman of U.S. Industries in Iselin, was Thomas”s main financial backer in 1999 and is now the privately held company”s largest shareholder. Clark estimates that he and Thomas together have invested nearly $5 million in the company so far.
EâÂÂmail to [email protected]
