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Chronix's serum DNA blood tests may be the newest way to detect breast and prostate cancer.  (Source: HowStuffWorks)
Report shows that Chronix's serum DNA assays head a new approach in diagnostics of cancer

Chronix Biomedical presented their study results at the 2010 ASCO Annual Meeting in Chicago, regarding its serum DNA blood tests. The DNA assays may be the newest diagnostic and prognostic approach in detecting breast and prostate cancer. The high numbers for sensitivity and specificity significantly outperformed the published accuracy data for current methods. 

By employing proprietary algorithms, developed by Chronix researchers, tests can detect and analyze, as well as identify cancer-related bits of DNA that are released by apoptotic cells into the bloodstream. However, only a few regions consistently show apoptotic DNA in the serum. These regions, named 'hotspots,' are specific to the type of cancer – only 29 breast cancer 'hotspots' and 32 prostate cancer 'hotspots' to be exact. 

"By focusing on these blood-born genomic 'hotspots,' we can reliably detect the presence of cancer without having to first isolate or analyze tumor cells," said Howard Urnovits, Ph.D., co-author of the study, and Chief Executive Officer of Chronix. He continued by explaining that Chronix tests for cancers would allow doctors to diagnose cancer at its earliest stages, allowing for greater care and optimize treatment using patients' disease-specific genomic fingerprints. 

The study involved 575 individuals: 200 healthy patients, 178 with early stage breast cancer, and 197 with invasive prostate cancer were employed. Chronix assays detected the breast cancer with a 100% specificity and 92% sensitivity, and prostate cancer with the same 100% specificity and 92% sensitivity. Current practices result in comparatively lower numbers, however, they cannot be directly compared. 

Mammograms have an overall sensitivity of 75% and specificity of 92.3%, as found by a large study of U.S. mammography screenings.The PSA (prostate specific antigen) test, currently used to detect prostate cancer, has an overall 85% sensitivity and 25-35% specificity. The future use of Chronix to detect cancer may reduce the current rate of false negative and false positive results, leading to an improvement in all areas of health care, ranging from patient outcomes to health care costs.

"These new data, although early, provide further evidence that Chronix's proprietary serum DNA assays may represent a new diagnostic and prognostic platform that can identify cancer earlier and more accurately than is currently possible," states breast cancer expert Steven Narod, M.D., F.R.C.P.C. 

This is not the first time Chronix released studies concerning new diagnostic approaches to diseases. Previous studies showed that the Chronix approach can identify the presence/absence of active disease in multiple sclerosis patients, as well as the detection of BSE, or mad cow disease, in veterinary applications.

Many look to these encouraging findings to service clinical researchers, as well as cancer patients. The future use of Chronix assays may in fact increase the survival rate among patients. 



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A matter of cost
By mcbaine on 6/7/2010 7:41:09 PM , Rating: 4
This is a really tremendous leap forward, especially with regards to prostate cancer screening. However, a major factor for this becoming more prevalent as a screening protocol will be the cost of the test. If the cost for this test is high right now, and doesn't come down in the near future (due to economies of scale, or technological advance), then this would sadly be relegated to being covered only by the most "cadillac" of insurance plans, or to those paying out of pocket.




RE: A matter of cost
By FITCamaro on 6/7/2010 8:15:57 PM , Rating: 1
Leading edge medicine costs money. Otherwise it would never get developed in the first place.


RE: A matter of cost
By Methusela on 6/7/2010 8:20:28 PM , Rating: 5
Let's just agree to call it bleeding edge medicine . Doesn't that have a better ring to it?


RE: A matter of cost
By bobcpg on 6/7/2010 11:31:02 PM , Rating: 5
I voted you +1 but I just have to reply. Like you said I believe this is the #1 reason these discoveries happen. The huge problem, it seems, most people do not realize this.

It all about the Benjamin's baby. Don't ever forget it.


RE: A matter of cost
By bupkus on 6/7/2010 11:43:45 PM , Rating: 2
I'll try to remember that should I ever have the choice of saving your life.


RE: A matter of cost
By Redwin on 6/8/2010 2:19:28 PM , Rating: 2
Oversimplify much?

Spending many years and tens of millions of dollars developing a cutting edge drug is not the same as deciding whether to push someone out of the way of a bus.


RE: A matter of cost
By bupkus on 6/7/2010 11:41:55 PM , Rating: 2
Just what does that mean?

Leading edge can just as easily be less expensive. If the accuracy of these tests lower overall costs by both reducing false positives and by earlier detection and treatment then it seems clear to be a win win.

I do see the point of the "Cadillac" poster; if this is the earliest detection of these cancers they would be applied pre-symptom based largely on family history. People worried about these 2 kinds of cancers will want a test done regardless of their family history.
Understandable as many people long ago may have gone undiagnosed even post-mortem.


RE: A matter of cost
By Kurz on 6/8/2010 4:35:52 AM , Rating: 2
The problem is mainly the FDA... It costs a fortune to get all the testing the FDA requires.

Plus the FDA prevents drugs that can save lifes, like this technology from getting to people who would benefit for years!!
By then its too late.

Case in point Beta Blockers.
The FDA kept them off the market for ~10 years then they declare we are able to save 250,000 a year. However, if they do the math 10x250,000 2.5 million people died from the FDA stepping in and preventing people that are already dying from getting a drug that could save their life.


RE: A matter of cost
By KillerNoodle on 6/8/2010 8:48:38 AM , Rating: 2
Isn't detecting different than treating?

Drugs are super costly to test because of the FDA's stringent safety criteria and requirements, but does testing have to go through the same channels?


RE: A matter of cost
By Jaybus on 6/8/2010 11:00:08 AM , Rating: 2
It is not much different. Diagnostic assays have to be proven to be accurate and specific to the disease they are testing for, else physicians could not rely on the test for diagnosis, so safety is also a big issue for diagnostics. There are related expenses in dealing with the FDA, but the principle cost is the clinical trials and is dependent on the number of patients the study requires.

Approval of a diagnostic can be as expensive as approval of a treatment, yet the income from selling diagnostic kits is not as high as the income from selling treatments. This is why we don't see as many new diagnostics as we do new treatments.


RE: A matter of cost
By MozeeToby on 6/8/2010 2:15:48 PM , Rating: 2
False positives cost money, false negatives cost lives; especially in this case where the test has the potential to be used millions of time a year. Diagnostic tests are just as important to test and verify before they go into the field as treatments, doctors have to know how much trust they can and can't put into the results.

The only good news is that the testing protocols should be relatively cheap, just get a bunch of people together that do and don't have the cancers, run their samples through your process and let statistics do the rest. It doesn't need to detract from their current treatments and it doesn't put the patients at risk which are two of the biggest hurdles of getting through FDA testing.


RE: A matter of cost
By Solandri on 6/8/2010 1:31:23 PM , Rating: 2
quote:
Case in point Beta Blockers. The FDA kept them off the market for ~10 years then they declare we are able to save 250,000 a year. However, if they do the math 10x250,000 2.5 million people died from the FDA stepping in and preventing people that are already dying from getting a drug that could save their life.

That's 20/20 hindsight.

During the time the FDA was keeping them off the market, they didn't know if it could save 250,000 lives/yr or kill 250,000 people/yr. Once the proper studies are completed and the FDA is reasonably sure about the safety of the drug/procedure, then they allow it to be released to the public.

And there is a procedure for terminally ill people to be treated with unapproved experimental medications/procedures if it's determined that they have nothing to lose.


RE: A matter of cost
By Kurz on 6/9/2010 2:11:29 PM , Rating: 2
>.> Of course someone knew it would save lifes.
Before it even comes to FDA approval the Drug Companies believe it'll be able to treat X.

The access to those unapproved experimental Meds is close to zero. Even if people know about the drug, they are forced to buying off the black market. Which makes it more expensive to buy the drugs.

Before the FDA it was bad business to kill the customer.
Or put fraud on the customer.

You don't need governmental regulation to step in and make decisions of life and death for the Citizens.


RE: A matter of cost
By bupkus on 6/8/2010 4:32:32 PM , Rating: 2
quote:
Leading edge medicine costs money. Otherwise it would never get developed in the first place.

Leading edge medicine is profitable for the pharmaceutical companies, otherwise it would never get developed in the first place. </fixed>


RE: A matter of cost
By protosv on 6/8/2010 9:42:25 AM , Rating: 2
Oh I totally agree. Somebody's gotta innovate, and it's gonna cost some money to do so, otherwise we'd still be bloodletting people for a fever. All I'm saying is that if the costs don't eventually come down, no insurance company is going to pay for this.

Take for example, genetic testing for hereditary diseases like Gaucher's, Tay-Sachs, etc.. My wife and I wanted to get screened for genetic "compatibility" to make sure we weren't both carriers for a disorder. The insurance company wouldn't cover it, even though it could end up saving them the possibly astronomical costs of treating an ill child. Their rationale is that "most people aren't both carriers, and if we covered this, then everyone would do it. In the long run, we save money by not covering this and having people take their chances."

Same applies here to this screen. Unless it will eventually be covered by insurance plans, this amazing breakthrough will never see widespread use. Insurance companies will just say "Well, most people don't have breast cancer or prostate cancer so it's not financially worth it for us to pay for this screening (although I believe I saw somewhere that close to 75% of men over 70 have it, but end up dying from something else over time first.)


RE: A matter of cost
By Jaybus on 6/8/2010 11:13:10 AM , Rating: 2
You have to compare apples to apples. Insurance companies already pay for mammograms and PSAs. This diagnostic looks to be better than either of those at detecting cancer. But if it costs 10x more, then they won't want to pay. It may, however, be cheaper than a mammogram that requires an expensive instrument. I doubt it is cheaper than a PSA. So they might pay for breast cancer screening and not prostate? Anyway, you have compare to cost of existing diagnostics.


RE: A matter of cost
By bighairycamel on 6/7/2010 9:19:44 PM , Rating: 3
I keep telling the old timers at work that by the time I need a prostate exam we will be able to detect it with PCR, avoiding the need for an invasive rectal screen. This pretty much solidifies it.

The less fingers in my bum the better and in 20 years I doubt this test will cost much especially if it is adapter for general public screens which it should be.


RE: A matter of cost
By BobbyBrown on 6/8/2010 5:32:19 AM , Rating: 3
Aww, I was actually quite looking forward to a prostate exam.

Such killjoys!


Big Leap
By MozeeToby on 6/7/2010 5:17:58 PM , Rating: 5
This is a huge leap forward in cancer screening if their research can be confirmed. A less than 1% false positive rate and less than 10% false negative rate is amazing for this kind of thing. If those numbers are accurate, cancer screenings could easily become part of your annual check up, just pee in a cup and catch a high percentage of cancers in the early stages.

I can only hope that their work is as impressive as they make it sound and that similar techniques can be used for other cancers. It might not be a single bullet cure, but it probably has the potential to immediately revolutionize care in a way that no treatment does.




RE: Big Leap
By Jacerie on 6/8/2010 9:44:34 AM , Rating: 2
I'm currently at the ASCO 2010 meeting and you would be amazed to see the amount and levels of research being done. It is quite impressive to see so many leading researchers and doctors collaborating on the scale happening here.


RE: Big Leap
By protosv on 6/8/2010 9:49:45 AM , Rating: 2
My guess is that it would all depend on the type of cancer. Different cancers grow, invade and apoptose differently, not to mention we need an early genetic marker that's detectable either by a blood draw or in urine. For now, it sounds like this finding is limited to these two types of cancer, but this could theoretically be extended....


An explanation would be appreciated
By gt1911 on 6/8/2010 3:45:23 AM , Rating: 2
Can someone give me a simple explanation of what the terms 'specificity' and 'sensitivity' mean in the context of medical research?

It seems like really good news, but I don't have a research background and I'd like to understand more.

Thanks in advance for your help.




By FoundationII on 6/8/2010 8:05:18 AM , Rating: 2
Specificity is the proportion of people who tested negative (for cancer in this case) out of the total amount of negative people. So false positives reduce specificity.
Sensitivity is the proportion of people who tested positive out of the total amount of positive people. So false negatives reduce sensitivity.


RE: An explanation would be appreciated
By protosv on 6/8/2010 9:57:39 AM , Rating: 3
Basically a simplification would be:

Sensitivity: A measure of how easily a test is able to detect the disease. For example, if you have 100 men with known prostate cancer and you screen them with this test, and it picks up 92/100 men as positive, then the sensitivity is 92%.

Specificity: A measure of how often a positive test result actually indicates that you have the disease. For example, take those 92 men who came up with a positive test screen. If 92/92 men who came up positive actually have prostate cancer then the specificity is 100%. If, for example, only 80/92 men who came up positive on the test actually have prostate cancer, then the specificity would be 80/92 = 87%


By gt1911 on 6/11/2010 10:44:45 PM , Rating: 2
Thanks for that. I think I get it now.


A humanitarian
By ClownPuncher on 6/7/10, Rating: 0
RE: A humanitarian
By wadewilson on 6/8/2010 7:07:09 AM , Rating: 3
He doesn't, that would be Dr. Dre.


RE: A humanitarian
By therealnickdanger on 6/8/2010 7:49:14 AM , Rating: 2
Come on now, we all know that the original was Dr. Funkenstein. His funk is the best. Coming to you direct from the Mothership.


By statistician on 6/8/2010 9:56:23 AM , Rating: 3
The main results are very different.
The main rigorous analysis suggests much less impressive figures. Check out the actual ASCO abstract:

http://abstract.asco.org/AbstView_74_49058.html

The only defensible numbers in the report are:
For prostate cancer: sensitivity of 80% at 96% specificity; for breast cancer: 73% at 96%, respectively.

The "92%" and "100%" figures came from an unreliable "further analysis". This is a subgroup analysis
done without any regard to statistical validity or reliability. Unfortunately, this is what made the headlines.




I love the pictures
By FaceMaster on 6/8/2010 5:14:39 AM , Rating: 2
Two test tubes full of blood, with a person in scientific clothing looking at them. That's what science is all about.




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