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GH215:
Urine Analysis for Prostate Cancer Study

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Urine Analysis for Prostate Cancer Study

For physicians who are considering prostate biopsies, use PanGIA Prostate prior to biopsy to help prostate cancer decision making.

Prostate Cancer Facts

  • • Prostate cancer affects only men.
  • • About 6 in 10 cases are in men age 65 or older.
  • • More than 200,000 men in the U.S. are diagnosed with prostate cancer every year.
  • • It is the second most common cancer among men in the U.S. (after skin cancer).
  • • Prostate cancer often has no early symptoms.
GH215: Urine in Prostate Cancer Study
The GH215 Study offers doctors a new diagnostic approach for prostate cancer, the second most frequent malignancy in men worldwide. We also offer healthcare professionals the ability to quickly, inexpensively, and easily stratify patients from a first morning voided urine specimen.
Technology

The GH215 study is a diagnostic platform that utilizes ‘NuTec signatures’ created by the unbiased binding of molecules from patient urine specimens as a means of detecting diseases in people. This platform has been successfully tested in various clinical proof of concept studies involving urine specimens from donors with and without various cancers and infections. 

GH215: Urine Analysis for Prostate Cancer Study – Positive Report Example
GH215: Urine Analysis for Prostate Cancer Study – Negative Report Example

Reduce unnecessary biopsies, Reduce unwanted side effects, Reduce wasted time, Reduce costs, Improve Patient Care and Safety

Superior Value
Value to Patients

• Improved predictive profile over PSA / other screening tests

• Avoidance or warranted delay of invasive procedures

Value to Physicians

• Additional data points for identifying candidates for biopsies

• Improved outcomes from missing fewer cancers and reduced side effects

Value to Payers

• Avoidance of unnecessary biopsies


• Avoidance of costs for side effects

A new test, using urine

  • Non-invasive
  • Machine Learning allows Deep Analysis
  • NuTec Slides powered by OpsisDxTM
  • Nanoscale Unbiased Textured Capture
  • Bio Molecular Signature Analysis

How the GH215 Study works:

Your patient provides a first morning void urine specimen

The GH215 Study's AI compares your patient’s bio molecular profile with the profile of men who have positive prostate biopsy and men who have negative prostate biopsy

You receive a report with Confidence Score

Practice Enrollment

(833) 443-6522

Contact your local Genetics Institute of America representative to order PanGIA Prostate.

Disclaimer: This test was evaluated, and its performance characteristics determined, by Genetics Institute of America. It has not been cleared or approved by the U.S. Food and Drug Administration. Such clearance or approval is generally not necessary. Genetics Institute of America is certified under the Clinical Laboratory Improvement Act of 1988 (CLIA) as qualified to perform high complexity testing.

Note: Please contact your insurance carrier for details regarding coverage for PanGIA Prostate.

Prostate Cancer Resources:

https://www.auanet.org/

https://www.cancer.org/cancer/prostate-cancer.html

https://zerocancer.org/

https://www.pcf.org/

http://www.prostatehealthed.org/ 

References:

  1. Lim, F. et. al., A urine signature array detects and distinguishes between multiple cancers. (submitted)
  2. Entopsis Document Number ISO_EO_TE_P-002 “Testing Urine Samples with NuTec Slides”

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