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experimental PSA blood test to prevent unnecessary biopsies

wsolstice
Posts: 2
Joined: Jan 2015

Hello, I am new to this forum and had my first PSA test last year.  It was normal but I have relatives who have died from prostate cancer.  I am an engineer and biotechnology entrepreneur.  My early stage start-up company is developing a prostate cancer blood test to discriminate between prostatitis, benign prostate hyperplasia (BPH) and prostate cancer – preventing unnecessary biopsies.  The test has been validated in a laboratory.  We are at the point of seeking seed stage funding to optimize and validate the test clinically on cancer patient blood samples.  I am not asking for money.  I am seeking feedback from men who had elevated PSA, then a biopsy, whether positive or negative, and the outcome.  Would such a test have been useful to your situation?  Why or why not?  Any feedback would be greatly appreciated.  Thank you.

Sincerely,

WSolstice 

hopeful and opt...
Posts: 2327
Joined: Apr 2009

Dear WSolstice,

Thanks for your research. I hope that you enjoy success.

I wonder how your test compares to a free PSA test.

http://www.harvardprostateknowledge.org/what-is-the-difference-between-psa-and-free-psa

and a PCA3 urine test.

 

I am sorry for the your family history of PCa. Stay viligent; PSA's and digital rectal exams.  Check the trend for your  PSA tests.

 

Best, 

H

 

VascodaGama's picture
VascodaGama
Posts: 3357
Joined: Nov 2010

WSolstice

Welcome to the board.

All non invasive ways to diagnose prostate cancer is good and advisable. I wonder how your simple blood test distinguishes between prostatitis, benign prostate hyperplasia (BPH) and prostate cancer.

The biopsy (a tissue sample) manages to do the same as you acclaim, adding other important characteristics of the cancer such as the aggressivity. It may be better than your test but it is invasive and got risks, as well as it is prune to errors (false negatives), dependent of pathologist’s experience. I would like to know more details about your test and how it discriminates in the analysis.

Your test may have limited uses, thought it will surely make the present PSA test obsolete because this does not diagnose cancer. The standards in PSA results (a table of risk-to-cancer grades) based in the volume of PSA serum is not good because it exams patients equally. Results (PSA) lower than 4 ng/ml are typically recommended as “good”.

I was diagnosed with cancer from a sextant biopsy at the age of 50 that found cancer in all cores. The biopsy was recommended because of an initial high PSA of 22.4 ng/ml and negative DRE and negative image studies. In 2000 PCa was not a typical sickness of young guys. If your blood test were used in my case (in 2000) it would have not been better than the risk-table used at the time  because of the high PSA (PSA< 4 ng/ml = normal; PSA> 4 to 7 ng/ml= to gray zone; PSA > 7 ng/ml= high probabilities of cancer). In any case, it would be excellent if I had a lower PSA that may have lead doctors to diagnose me with a false negative.

I hope success in your researches. Be vigilant with your risks for PCa (hereditary). Best wishes.

VGama

 

wsolstice
Posts: 2
Joined: Jan 2015

Thank you for responding and for your input. Our test enables 2-D microfluidic analysis of glycoproteins by proprietary digital isoelectric fractionation (dIEF) followed by highly sensitive antibody-based detection. There is growing research showing a correlation between aberrant glycosylation of cancer protein biomarkers and the aggressive forms of cancer. Our test is not intended to replace the biopsy, just verify the need by diagnosing benign conditions from cancer. There are approx. 1 million prostate biopsies performed annually in the U.S. and 75% are negative, finding no cancer. The test measures glycoprotein cancer biomarkers with a unique approach, combining highly specific immunodetection with equal or greater detection sensitivity (>10-fold lower detection limit than conventional ELISA) together with resolution of glycomic aberrations potentially enabling more sensitive patient monitoring and early detection Ref. Aberrant PSA glycosylation--a sweet predictor of prostate cancer. http://www.ncbi.nlm.nih.gov/pubmed/23318363

Swingshiftworker
Posts: 1013
Joined: Mar 2010

Any test that can reliably detect prostate cancer and eliminate the need to resort to unncessary biopsies would be useful, given the risk of infection and the possibility of false negative results associated with prostate biopsies.

hopeful and opt...
Posts: 2327
Joined: Apr 2009

A situation where this test can be useful:

I am enrolled in an active surveillance program. My next biopsy is schedule 1 1/2 years from now. Six months ago, my PSA rose to 5.4 from 4.1 number of  8 months before. During the same time frame my free PSA rose from 20 to 24. Some of the PSA rise is not explained....is it cancer or prostatitis. It would be ggreat to know by using your blood test,  instead of  having the  more invasive biopsy.

VascodaGama's picture
VascodaGama
Posts: 3357
Joined: Nov 2010

WSolstice

Thanks for replying. I hope you do succeed in getting your experimental PSA test into real practice, even if it just discriminates benign conditions from cancer (as you suggested above).

In fact there have been needs in new ways for testing prostate cancer because the present “PSA standard” is not good enough and the biopsies are invasive and may not “catch” the bandit in its way. Surely, in the last decade there has been a huge surge in treatments solo due to PSA diagnosed cases, many of them taking care of cancers that may have not needed to be treated.

Some cancers are just sort of indolent but produce PSA. These probably would not be a life threatening cause to the patient but the majority of doctors would have no way other than recommending a treatment. That is their motto, “to treat the malady”, and the guide lines from their associations do not recommend palliative forms of therapy, particularly in young guys. This leads to think that the newer tests should not just diagnose cancer from benign but go further and indicate the type of cancer that may be prune to disease progression. I see it as a simple test useful in the screening process that will avoid over diagnosis.

I noticed from your provided link that the authors are from Dublin, Ireland. You may know about another test researched in the UK named EN2 urine test that do not require the painful prostate massage (http://en2prostate.co.uk/). There is also a newer approach to the above called Mi-Prostate Score (MiPS), which is also a urine test. This incorporates two molecular markers; the original RNA made from a gene (PCA3) (discovered in the 1970s) that is overactive in 95 percent of all prostate cancers, and the RNA that is made only when two genes (TMPRSS2 and ERG) abnormally fuse. This urine test is considered invasive because it requires the painful massage of the prostate before urination. Urine tests though do not need "invasive" needles to draw blood. You may read details here; http://www.pcf.org/site/c.leJRIROrEpH/b.8833993/k.EC93/
New_Urine_Test_for_Prostate_Cancer_Available_Unlike_PSA_Test_is_UltraSpecific_for_Prostate_Cancer.htm

 

Best wishes.

VGama

 

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