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Detecting cancer: Claros Diagnostics has developed a microfluidics cartridge and reader (above) designed to detect PSA levels in prostate cancer patients in just 15 minutes.
Claros Diagnostics
A new microfluidics device gives results in 15 minutes.
In an office park in Woburn, MA, a volunteer presents his fingertip for a quick finger stick. A phlebotomist wicks up the small drop of blood with a specially made square of plastic, then snaps the plastic into a credit-card sized microfluidics cartridge and feeds it into a special reader. Fifteen minutes later, the device spits out the volunteer's prostate specific antigen (PSA) level, a protein used to monitor the return of prostate cancer after treatment.
The rapid results are possible because of a novel microfluidics technology developed by startup Claros Diagnostics, which hopes to make quick PSA monitoring in the doctor's office a reality. If approved by the U.S. Food and Drug Administration, the device will be one of the first examples of long-awaited microfluidics-based diagnostics tests that can be performed in the hospital or doctor's office. While microfluidics--which allows for the manipulation of fluids on a chip at microscopic scales--has been around for a decade, the complexity and expense has kept it largely limited to research applications.
Claros's technology, which consists of a small blood-collector device, a disposable cartridge, and a toaster-sized reader, could, in theory at least, be adapted to detect any number of different proteins. But the company has initially chosen to focus on PSA, which is routinely monitored. With current testing, blood samples are typically sent to a centralized lab for PSA analysis. Results are returned in a day or two. Claros's test, now in clinical trials, would allow PSA readings to be determined during the patient's visit. While there is debate over how useful PSA testing is in diagnosing cancer, it is a well-accepted tool for monitoring those who have it. Within a month after prostate surgery, a man's PSA levels drops--a subsequent increase suggests that PSA producing cancer cells have returned.
"Having a quick PSA test that is accurate would certainly be helpful to most urologists--simple and inexpensive being the two key words," says Jerome Richie, chief of urology at Brigham and Women's hospital in Boston. But he says that such a test must be able to accurately analyze the low levels of PSA that are present after prostate surgery.
Key to Claros's device is its ability to perform the test on a small drop of blood. The surface of the cartridge is covered in narrow channels, which serve as both storage for the chemicals needed for the assay and as tiny test tubes in which to carry out the reaction. Each reagent is lined up sequentially in one long channel and separated by small air bubbles. Once the cartridge is inserted into the reader, a vacuum pulls the blood through one channel and delivers the appropriate sequence of reagents. This approach avoids the pumps used to move chemicals in other microfluidics chips, enabling a simple and robust design with no moving parts. The reader itself is simple, using an LED and photodiode to detect the buildup of silver--the output of the reaction--on the cartridge. The more silver, the less light passes through the chip and the higher the PSA level.
Claros plans to market the device to urologists monitoring prostate cancer patients after treatment. The controversy around PSA testing is centered around using the test to detect cancer, not monitor it.
This is why I read the comments
Good point made by fiberman, and good clarification by Ms. Singer. Also, make sure you read page 2, where Claros comes off sounding better than they do based only on page 1.
Manufacturing in the United States is in trouble. That's bad news not just for the country's economy but for the future of innovation.
fiberman
185 Comments
Great- faster results for a useless medical test!
How about factoring in the current updates on the effectiveness of all these cancer tests? Dr. Richard Ablin of the University of Arizona, developer of the PSA test called the prostate test a 'public health disaster' and a news report of a new ovarian cancer test showed 64% false positives. New studies show even breast cancer screening does not save lives. Does anybody care that the fact that these tests are wrong most of the time cause massive personal suffering for the profit of the medical business?
The "for profit medical biz", including health insurance companies, drug companies, medical device suppliers, and for-profit hospitals should consider whether they are going to be the next financial bubble, facing a meltdown as their business eats up almost 20% of the US economy yet we have one of the least healthy populations who are rapidly losing the ability to pay the ever-escalating costs.
It's beginning to look like the housing bubble to me.
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djweber
10 Comments
Re: Great- faster results for a useless medical test!
We Americans love our tests, even if they make us sicker.
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fiberman
185 Comments
Re: Great- faster results for a useless medical test!
Yep - read this:
http://www.reuters.com/article/idUSTRE62957920100310?feedType=nl&feedName=ushealth600
Reply
rhansing
74 Comments
Re: Great- faster results for a useless medical test!
I disagree as a pathologist. The PSA test first creates awareness. Prostate cancer used to be the type of cancer men were ashamed of and didn't talk about, the same with breast cancer.
And second, yes, the differential is between benign hypertrophy of the prostate gland vs. cancer. However, depending on age, rate of increase and a digital rectal exam, the information becomes more strongly suspicious.
In addition, there is the free PSA test which can be ordered if the data suggest a cancer.
The public has the idea that all tests are great tests... that's not the case when one deals with biological variability. The PSA test alone, is a "weakly" good test, but must better with history, physical exam, racial grouping and prevalence of population.
The same applies to drugs, most are good drugs but not great drugs. Again, that's due to biological variability.
I do agree that some genetic tests and many other tests may look like poor tests, but dependant of the prevalence of the disease in a particular population, the specificity and sensitivity can be greatly enhanced.
Rather than simply say that the test is a waste, based on one doctor's opinion, is simplistic. Many doctors would disagree. As well as many patients.
The decision should be made by the physician and the patient only. One size does not fit all in medicine.
If there is a suspicion of cancer, prostate biopsies can be performed very cheaply as an out patient. Yes, not all will be positive, but again, that's why one performs tests, to rule out or rule in disease. In addition, just because the test is negative, it does not mean that the biopsiee sampled the correct area in order to find a small cancer that is curable.
I caution everybody to be careful of making assumptions based on limited data. (One article)
Yes, the treatment is radical, but then again, that is the decision between the doctor and patient, NOT someone else.
The best way to treat cancer is to cut the damn thing out... this treatment is the most successful.
And for me, I want to know if I have an early cancer that can be cured. Others may not care... regardless of the complications and side effects, I can accept them, because alternative is unacceptable to me.
Lastly, why have medicine anyway, think of the money we could save. One could argue that any test or medical procedure is worthless. But what is worthless. Who decides. Uncle Sam or the doctor –patient relationship?.
ron hansing md
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fiberman
185 Comments
Re: Great- faster results for a useless medical test!
Spoken as a real Doctor.
Get positive test results - start treatment. How about commenting on my friend who was given radiation treatment for prostate cancer he did not have or relative who underwent multiple biopsies on a false positive breast cancer diagnosis?
Read carefully, the doctor calling the PSA test a public health disaster was the one who discovered it. The second head of the Framingham Heart Study, Dr. Castelli, has been trying to debunk the cholesterol connection to heart disease, created by a predecessor who was on the payroll of several drug companies.
In today's San Diego Union Tribune, a front page story talks about UCSD wanting to build a hospital to compete in a "lucrative" market.
The "for-profit medical business" is doing as much harm as good.
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