Not Feeling Well? The Microchip Will See You Now
In a few decades, doctors will be able to check their patients’ hereditary makeup in precise detail--identifying thousands of variations in an individual’s genes in order to prescribe just the right medication to treat an illness or to predict the likelihood of contracting diseases such as cancer, Alzheimer’s or heart disease.
But Clinical Micro Sensors isn’t waiting for that day.
The young Pasadena biotechnology firm believes that doctors, hospitals and drug companies need such tests right now, based on a surge of new genetic information about individual responses to disease and medications.
The privately held company, founded in 1995 and backed by $24 million in funding, has developed disposable plastic chips that can test for a hundred or more genes at a time and do so cheaply--hastening the day when reading a patient’s genes will become a routine part of medical care.
The company uses tiny genetic probes--short lengths of DNA with iron atoms attached--to detect the presence of genes electronically in a sample of blood or other bodily fluid.
While ingenious, the approach is not as high tech as the methods employed by some of its competitors--companies such as Affymetrix and Incyte, which can cram genetic tests by the thousands onto a square inch of glass to obtain a more complete genetic profile.
Jon Faiz Kayyem, Clinical Micro Sensors’ co-founder and chief executive, argues that doctors and drug companies don’t need anything that complicated and won’t for many years--if then. These potential customers want to look at a few genes at a time--as few as two or three, as many as 100.
Simpler Chips to Sell for Less Than $20
Instead of making high-density chips that can cost thousands of dollars apiece, the company is making simpler electrical chips that look like they were plucked from the innards of a personal computer and that will sell for less than $20.
“When a patient comes to a doctor with an undefined ailment, there’s no need to test for tens of thousands of things,” Kayyem said. “If the patient has a sore throat, there are a handful of viruses and a handful of bacteria to test for.”
“We’re sticking with the testing the customer wants, which is in the dozens range,” said Kayyem, who got his doctorate from Caltech in 1991 and stayed on as a postdoctoral fellow.
The tests can be done quite efficiently, he said, using a system he developed while working in the lab of Caltech senior researcher Thomas J. Meade, a co-founder of the company.
The scientists came up with a clever way to test for the presence of specific genes that requires relatively little preparation and that uses disposable plastic chips that can be produced with automated equipment for less than $2 each.
The chips can be tailored for specific uses: testing for the human genes that can predict which blood-pressure medication is best for an individual patient, or quickly checking a blood sample for bacterial and viral genes to determine if a patient has a sexually transmitted disease, so a doctor can prescribe the right treatment immediately, without requiring a return visit.
The same elegant technology can also be used to test meat or drinking water for contamination by disease-causing bugs. Similarly, a small number of gene probes could be used for genetic fingerprinting, but any new method for doing so would require broad acceptance by law enforcement authorities.
Sensors Especially Useful to Drug Firms
Drug companies in particular are clamoring for such tests, knowing that in many cases a handful of genetic differences will explain why an experimental drug works in one patient but not in another--or why a medication causes toxic reactions in some but not in others.
Clinical Micro Sensors has hooked up with Motorola’s BioChip Systems division--one of its investors--to produce electronic devices that will read the chips. One version is about the size of a tape recorder and runs on batteries; another device in development is as big as a toaster oven and can test as many as 96 samples at a time.
Because the components are all off-the-shelf, the devices are relatively low cost. And, at least at first, the company might give them away, just as mobile-phone companies offer free phones to subscribers. Clinical Micro Sensors will find its profit in manufacturing the customized chips by the thousands, or, for some applications, by the millions.
Kayyem is hoping that the flexible system--which uses genetic probes provided by its pharmaceutical company customers--will become an industry standard, used by drug companies as they test new products and later by clinical laboratories to determine the best treatment for each patient.
Clinical Micro Sensors isn’t the only company entering this emerging market for gene-based testing.
And analysts say that there could be lots of competition.
“This is a rapidly burgeoning frontier that will be fundamental to the future of medical science, ranging from how to discover drugs to monitoring their effectiveness,” said Viren Mehta of Mehta Partners, a Wall Street firm that follows the industry. “Affymetrix has established a pioneering position with their microchip . . . but there is an opportunity for a more focused series of products aimed at different specific needs where the mass coverage is not needed.”
As the field develops, Clinical Micro Sensors could find itself competing with medical testing giants with worldwide distribution systems, such as Abbott Laboratories or Roche Diagnostics, noted Dr. Jonas V. Alsenas, an analyst with ING Barings.
Alsenas recognizes that the new, gene-based testing will eventually displace the more cumbersome, traditional methods for diagnosing disease. Laboratories now have a variety of methods for identifying the cause of an illness--some require microscopic examination of tissues or growing tiny organisms, a process that can take days.
“Genetic tests will be more accurate than current microbiology and much more specific,” he predicted.
Clinical Micro has received $3 million in grants from the Commerce Department’s Advanced Technology Program. The federal agency is investing more than $100 million in developing tools that will ensure that the U.S. is a leader in DNA diagnostics--a market that it predicts will grow to $6 billion worldwide by 2005.
For several years now, drug and biotech companies have been using high-density DNA chips to look for differences between healthy and diseased tissue in the search for new drug targets.
Genes Play Role in Drugs’ Effectiveness
Researchers are increasingly realizing that small genetic variations among individuals can explain why a drug might work in, say, only 60% of patients and cause deadly side effects in 5%.
One result: Drug companies are looking at tiny genetic differences among patients when they begin testing their latest experimental medications.
And as drug companies learn the importance of those variations, they are looking for mass-produced tests that can be used to screen patients.
Kayyem makes it clear that Clinical Micro is not a gene discovery company, searching for genes that will unlock the mysteries of a disease. Nor is the company interested in the “ethically charged” arena of testing for hereditary disorders when little can be done to prevent development of disease.
Kayyem’s company, which has grown to 61 employees, is firmly entrenched in Pasadena. Its plant is not far from Caltech. And as it expands, it hopes to move to the city’s proposed technology corridor.
“I’m sometimes asked, ‘How can you be a player and not be in Silicon Valley?’ ” In fact, he said, scientists and engineers from Los Angeles’ dwindling aerospace industry and from Caltech’s Jet Propulsion Laboratory have the kind of expertise the company needs.
“For the things we do,” Kayyem said, “Los Angeles is very big.”
