Prostate biopsy blood in urine

PCA3 Assay, Prostate Biopsies, PROGENSA, Prostate Cancer Urine

FDA Approves Hologic Gen-Probe’s PROGENSA® PCA3 Assay,
First Urine-Based Molecular Test to Help Determine Need for Repeat Prostate Biopsies

The US Food and Drug Administration (FDA) has approved its PROGENSA PCA3 (prostate cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.

“When used in conjunction with other diagnostic information, our PROGENSA PCA3 assay provides clinically important information that helps physicians and their patients make better, more informed decisions about one of the most vexing problems in prostate cancer diagnosis, ” said Carl Hull, Hologic Gen-Probe’s Chairman and Chief Executive Officer. “From a commercial perspective, this is the third of four potential US regulatory approvals that we expect to generate a significant new sales growth cycle for the Company.”

“Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue, ” said John Wei, MD, MS, Professor of Urology at the University of Michigan Health System. “When evaluated with other risk factors, the PROGENSA PCA3 assay fills an important unmet clinical need by helping physicians identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy.”

The PROGENSA PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on the current standard of care, before consideration of PROGENSA PCA3 assay results. A negative PROGENSA PCA3 assay result is associated with a decreased likelihood of a positive biopsy. A prostate biopsy is required to diagnose cancer.

Black Box Warning: The PROGENSA PCA3 assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy. Men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.

Warning: The clinical study of the PROGENSA PCA3 assay only included men who were recommended for repeat biopsy. Therefore, the performance of the assay has not been established in men for whom a repeat biopsy was not already recommended.

FDA approval of the PROGENSA PCA3 assay was based on a clinical study that began in August 2009 and concluded in May 2010. The study enrolled 495 eligible men at 14 clinical sites. Hologic Gen-Probe submitted a Premarket Approval Application (PMA) to the FDA in August 2010.

In the clinical study, the PROGENSA PCA3 had a negative predictive value of 90%, meaning that a negative PROGENSA PCA3 assay result predicted a negative prostate biopsy 90% of the time.

Well, I need to obtain my old records first.

by -

I am disgusising my location, not really in Islip. I can pick up the records at my old doctor today, I'm thinking i should drive them over to the new doctor and just ask to get a quicker appointment than 2 weeks. New doctor took blood and urine samples, and says tey have to wait for lab results anyway, so just give it 2 weeks. He told me not to tell my partners yet either. But this seems too long to wait.

New here waiting for blood test results

by ShyBeadGirl

I just really needed to get this out of my system. I don't know all the lingo so sorry if this is a little long. We've only been ttc for the last few months and I wasn't expecting anything to happen any time soon. I get paranoid every month and always end up taking a test right before my period begins tho lol. This week I was really sick to my stomach and dizzy so I took a test and got a super faint line. I've been getting sick every night, peeing more and my back is killing me! Went to the lab today to get checked for a kidney infection and did a urine preg test and did a blood pg test. I won't get the results until tomorrow on the blood one

Hmm, any chance it's cushings disease?

by solightlyhere

Sorry if you mentioned this in a former post... but, might be worth looking into Cushings Disease if you haven't already. My dog (14 years old) recently got a blood panel done and one of her liver enzymes were elevated. The vet said this might indicate Cushings, pending further urine analysis. I went online and read about the symptoms, and sure enough - heavy panting is definitely one of them. Not sure about shivering, though. Other symptoms included increased drinking, increased urination, and an absence of arthritis pain (cushings is caused by a growth that effects the pituitary, causing cortisol levels to go up, which i suppose ironically helps with athritis symptoms

This is worse that Pelican Drinking

by that_is_a_treat

More than three million Chinese drink their own urine in the belief it is good for their health, the official Xinhua news agency reported on Friday.
Participants at a recent seminar on the practice in the northeastern city of Shenyang were told that urine contains many active ingredients which strengthen the immune system, Xinhua said.
"Urine contains no bacterium and is more sanitary than blood," Yang Liansheng, a professor from the Liaoning Institute of Traditional Chinese Medicine, was quoted as saying.
Engineer Zhu Jinfu told the seminar he had been drinking his own urine since he was 13 and had lived a healthy life for the last 58 years, Xinhua said

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