OncoPROSTATE

Non-Invasive Blood Test to Help in Diagnosis of Prostate Cancer

bioprognos
 PROSTATE CANCER STATISTICS
Global
Prostate Cancer is the third leading cause of cancer death in American men, behind Lung Cancer and
Colorectal Cancer. About 1 man in 39 will die of Prostate Cancer.

Prostate Cancer can be a serious disease, but most men diagnosed with Prostate Cancer do not die
from it. In fact, more than 2.9 million men in the United States who have been diagnosed with Prostate
Cancer at some point are still alive today.

Number of New Cases and Deaths per 100,000

The number of new cases of Prostate Cancer was 119.8 per 100,000 men per year. The number of
deaths was 20.1 per 100,000 men per year. These rates are age-adjusted and based on 2010-2014
cases and deaths.

Percent Surviving 5 Years

Based on data from SEER 18 2007-2013, only the 98.6% of patients being diagnosed with Prostate
Cancer will survive 5 years or more. Gray figures represent those who have died from Prostate Cancer.
Green figures represent those who have survived 5 years or more.

98.6%

Lifetime Risk of Developing Cancer

Approximately 11.6 percent of men will be diagnosed with Prostate Cancer at some point during their
lifetime, based on 2012-2014 data.

Prevalence of This Cancer

In 2014, there were an estimated 3,085,209 men living with Prostate Cancer in the United States.
RISK FACTORS SYMPTOMS & SIGNS
Age Problems passing urine,
including a slow or weak urinary
Race/ethnicity stream or the need to urinate
more often, especially at night
Geography
Blood in the urine
Family history
Trouble getting an erection
Gene changes (erectile dysfunction)

Diet Pain in the hips, back (spine),

chest (ribs), or other areas from
Obesity cancer that has spread to bones

Smoking Weakness or numbness in the

legs or feet, or even loss of
Workplace exposures bladder or bowel control from
cancer pressing on the spinal
Inflammation of the prostate cord

Sexual transmitted diseases

(STD)

Vasectomy
 PROGNOSIS
Prognosis refers to the likely outcome, or forecast, of a disease. For cancer, it refers to the chance of recovery
or recurrence. The prognosis for Prostate Cancer is an estimate based on the course of the disease taken from
studying hundreds or thousands of people who have been diagnosed.

In stages I and II where there is no sign that the cancer has spread outside of the prostate the relative
5-year survival rate is nearly 100%.

About 4 out of 5 Prostate Cancers are found in this

early stage.

As long as the cancer has spread from the prostate

to nearby areas cancers in stage III and IV the
relative 5-year survival rate for regional stage is
nearly 100% too.

However, in stages that have spread to distant

lymph nodes, bones, or other organs the chances
to survive in the next 5 years decreases drastically
to only 28%.

STATE OF THE ART IN PROSTATE CANCER DIAGNOSIS

Currently, Prostate Cancer diagnosis is done by a prostate biopsy (a test to remove small samples of
prostate tissue to be examined under a microscope).

A biopsy may be done when the PSA Test is performed and high levels of Prostate-Specific Antigen if
found in blood, or after a Digital Rectal Exam (DRE) finds an abnormal prostate or a lump.

For a prostate biopsy, a thin needle is inserted through the rectum (transrectal biopsy), through the
urethra, or through the area between the anus and scrotum (perineum). A transrectal biopsy is the most
common method used. The tissue samples taken during the biopsy are examined for cancer cells.
 DIAGNOSIS REVOLUTION
OncoPROSTATE is based on a simple blood test that can detect Prostate Cancer with 81.7% of
sensibility and 98.2% of specificity.

OncoPROSTATE reduces in a very significantly way, the number of false positives (FP) and false
negatives (FN) typical of other diagnosis procedures.

OncoPROSTATE can reduce the number of unnecessary tissue biopsies that patients have to undergo
when suspicious finding.

OncoPROSTATE has been performed with data from 3.725 consecutive patients, then fine-tuned by
other research.
 WHY CHOOSE BIOPROGNOS TEST?
Innovative
Based on the combined count of PSA, fPSA, p2PSA and hK2 Tumor Markers; as well as over expression
of Post-DRE PCA3 and T2:ERG genes.

Non-invasive
First test based on a simple blood test.

Accurate
Very high diagnostic capabilities: 81.7% Sensitivity and 98.2% Specificity.

Cost-effective
Solution to help in Prostate Cancer diagnosis as well as confirmatory diagnostic as an adjunct to
suspicious image procedures findings, in order to reduce the number of unnecessary tissue biopsies
that patients have to undergo.

Already validated
CE Declaration of Conformity reached (According to Annex VII of Medical Device Directive 93/42/EEC).

FOR WHOM IS IT INTENDED?

Men older than 50 years with PSA blood levels higher than 4 ng/mL.

Patients with previous image findings suspicious of Prostate Cancer that should be biopsied to verify
malignancy.
 USES AND PURPOSES
Aid in diagnostic assessments for high-risk patients.

Confirm or discard malignancy from results obtained previously with other tests, such as Computed
Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) findings thanks to higher Sensitivity and
Specificity than imaging procedures.

Therapy monitoring (how the cancer is responding to treatment) and predict or monitor for recurrence
(detecting a recurrence sooner than other methods).

INTERPRETATION OF RESULTS
Once the blood is analyzed and the Tumor Marker values are calculated, a final report with the probability of
finding Prostate Cancer is generated.

This report includes all patient information previously collected, results, comments if available, as well as
conclusions. It also includes a comprehensive 3 level color score bar to facilitate test interpretation in an easy
way, which can result in Negative, Low Positive and High Positive as follows:

The meaning of these segments of the score bar is:

Negative: There is a very low risk of Prostate Cancer, with a probability of 99.9% and it is
recommended to repeat the test in one year due to low risk of malignancy.

Low Positive: There is a certain chance of Prostate Cancer that does not allow to exclude malignancy.
The specialist will decide what further steps to follow. Of every three individuals with Positive Low
result, 1 will present Prostate Cancer.

High Positive: There is a very high risk of Prostate Cancer, with a probability of 99.9%.
 bioprognos

Improving clinical outcomes and quality of life

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