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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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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
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.

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