Area biotech firm passes FDA test
After 10 years of development, Quantimetrix Corp. of Redondo Beach has won approval from the Food and Drug Administration for its cholesterol-measuring device, the company said.
The FDA move could be a boon for the private company, which had $8 million in sales last year. The new product also may boost the stature of Los Angeles County’s fragmented biotechnology sector, which is overshadowed by San Diego and San Francisco.
Quantimetrix is touting the Lipoprint System as a faster, cheaper and more effective alternative to other such devices on the market. With FDA approval, the company’s next major step is to market Lipoprint.
“It’s marketed to reference laboratories,” said Jon Gilchrist, senior vice president of marketing and business development at the company. “We’re marketing it to people who are interested in their health. So when they go to their doctors (they’ll ask about it). It’s got to get known by the doctors in the field who are not used to having this (level) of information. There are 100 million cholesterol tests run in the United States each year and none of them have this level of detail.”
Winning FDA approval for a medical device or procedure is a major challenge, said Daniel Hollander, president and CEO of the Harbor-UCLA Research and Education Institute in Torrance.
“It’s very difficult because they really have to go through incredible hoops,” Hollander said. “They have to prove not only the reliability of the process but its innovation so that it doesn’t duplicate other processes. And they have to prove its safety.”
But that’s just the first of many obstacles for the company, Hollander said.
“There are many ways to assess lipoprotein (cholesterol),” he said. “You have to prove that your process is better, it’s cheaper, and the insurance companies will pay for it. Most physicians and hospitals want to make sure the insurance companies will reimburse them for the products or procedures before they use them. So you have to deal with the insurance companies’ reluctance to pay for procedures.”
The Lipoprint System goes beyond measuring a patient’s cholesterol level, which is what a typical test does, the company said. The device measures the various subfractions, or particles, in cholesterol to give a more detailed assessment of a patient’s health.
The greater detail can allow doctors to better prescribe heart medicine.
The test can be completed in less than two hours – as opposed to two weeks for many equivalent tests – and at one-twentieth of the cost of conventional methods, the company said.
The potential market is huge. The National Institute of Health estimates that 65 million Americans are on a dietary treatment for cholesterol and 36 million are prescribed cholesterol-lowering drugs.
Unlike other parts of the state such as San Diego and San Francisco, Los Angeles County doesn’t have a concentrated biotech sector. That’s a detriment to companies like Quantimetrix, Gilchrist said.
“We could do better with collaborations and grant funding if there was more of a biotech community that we could interact with like with in San Francisco and San Diego,” Gilchrist said.
But Hollander said new locally made products, such as Quantimetrix’s Lipoprint System, could help boost the profile of Los Angeles in the biotech industry. “Every little bit counts,” Hollander said.