Diabetics Have Alternative to Laboratory Testing
UCSD professor Dr. Steven Edelman is convinced he has found a method for diabetics to gain better control of their health.
According to Edelman, the answer lies in a hand-held meter developed by LXN Corp. in San Diego.
It allows patients to self-monitor their daily blood sugar levels. In addition, it also lets patients measure continuous blood sugar level changes previously only available through lab testing, Edelman said.
At a recent meeting of the American Diabetes Society in San Antonio, Edelman described how 15 diabetics using LXN’s once-a-week test for glucoprotein (fructosamine) in addition to daily glucose testing saw a 13 percent improvement in their blood sugar results after 90 days.
That compares to a 3 percent improved reading for the control group of 15 diabetics testing for glucose alone.
“That is a huge difference,” Edelman said.
The sooner diabetics learn their glucose levels are too high, the faster they can get their doctors to recommend changes in their medication, eating habits or exercise, he explained.
Edelman believes LXN’s test is likely to replace the “golden standard,” another glucoprotein test requiring laboratory testing.
Compared to the LXN test which interprets blood sugar changes over the past two or three weeks, the standard test evaluates continuous glucoprotein changes over the past two or three months, said Edelman, who has no financial ties to the company.
A high blood sugar reading is a good indicator that patients need to change their regimens to avoid serious complications, including kidney failure and blindness.
Psychological Roadblocks
Still, many diabetics simply won’t get tested.
“It’s a psychological thing,” said Edelman, himself a diabetic.
Many patients know their blood sugar levels aren’t up to par and thus avoid testing out of embarrassment or fear of repercussions, he said.
The trip to the laboratory, the dreaded prick with the needle, the two-day or longer wait for the results is far more complicated than a home test that requires a single drop of blood and gives patients results in minutes, Edelman said.
Michael A. Beeuwsaert, LXN president and chief executive officer, finds Edelman’s independent study supports the validity of the product.
The test kit , a hand-held meter device, 25 glucose test strips and 4 glucoprotein test strips , received Food and Drug Administration approval for over-the-counter sales in August 1999, he said.
The kit costs $74.95 and is available in Wal-Mart stores in North Carolina, and in Los Angeles, Chicago and Atlanta, he said.
One kit lasts about one month.
Some health insurance firms, including Aetna Inc. of Hartford, Conn., and Blue Cross and Blue Shield, have agreed to reimburse patients, Beeuwsaert said.
He said the test trademarked under “In Charge System” has seen wide acceptance elsewhere.
Yet, LXN has yet to make a breakthrough in San Diego’s tightly controlled managed care market, he added.
Beeuwsaert wouldn’t say how many tests have been sold so far. The outlook is good, he added, considering the $3 billion worldwide medical diagnostic market.
He said LXN’s rivals, including LifeScan in Milpitas, Calif. (a unit of Johnson & Johnson Co.), and MediSense in Bedford, Mass. (a unit of Abbott Laboratories), are selling rapid glucose tests.
Leading The Field
Edelman is convinced LXN is sitting on a gold mine considering its competitive edge. Another local diagnostic maker also praised LXN’s product.
Randall Nelson, president and chief executive officer of Equidyne Corp. in San Diego, which sells a needle-free device for diabetic users, said diabetics like the idea of not having to get their blood drawn in laboratory testing.
“It’s nice that they have everything (two indicators) on one monitor,” Nelson said. No other company has achieved that so far.
Edelman agreed, saying LXN’s meter is the only product on the market measuring both, daily glucose levels and continuous changes in blood sugar levels.
Beeuwsaert said LXN plans to expand its products into the European and Asian markets.
In February, LXN signed an agreement with the Hercules-based diagnostic firm Bio-Rad Laboratories Inc. to bring its device overseas.
LXN’s 10 salespeople are selling a larger first-generation device to doctors nationwide.
The smaller second-generation device for consumers is being distributed to pharmacies by the San Francisco-based health care firm McKesson HBOC, Inc., he said.
LXN, founded in 1994, is a privately held medical diagnostic firm.
The company has a total of 70 employees.
At its headquarters on Lusk Boulevard, LXN is engaged in research and development as well as manufacturing of all chemistry, he added.
