OncoCUP

Non-Invasive Blood Test to Help in Diagnosis of Cancer Unknown Primary

bioprognos
 UNKNOWN PRIMARY STATISTICS
Global
The exact number of Cancers of Unknown Primary (CUP) diagnosed each year is unknown, because
some cancers start out being diagnosed as Unknown Primary, but the primary site is found later. Still,
the American Cancer Society estimates that about 33,770 cases of cancer of unknown primary will be
diagnosed in 2017 in the United States.

This number represents about 2% of all cancers. As more sophisticated lab tests become available to
determine where a cancer started, the number of cancers of unknown primary may go down.

Number of New Cases and Deaths per 100,000

The number of new cases of Unknown Primary Cancer was 4.1 per 100,000 men and women per year.
Median survival of all CUP patients is 3 months, with no improvement over time. The number of deaths
was 3.6 per 100,000 men and women 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, less than 10% of patients being diagnosed with Unknown
Primary Cancer will survive 5 years or more. Gray figures represent those who have died from Unknown
Primary Cancer. Green figures represent those who have survived 5 years or more.

8.2%

Lifetime Risk of Developing Cancer

Approximately less than 1 percent of men and women will be diagnosed with Unknown Primary Cancer
at some point during their lifetime, based on 2012-2014 data.
RISK FACTORS SYMPTOMS & SIGNS
Tobacco smoke A cough that does not go away
or gets worse
Exposure to second-hand
smoke Chest pain that is often worse
with deep breathing, coughing,
Exposure to radon gas or laughing

Exposure to asbestos and other Hoarseness

carcinogens
Weight loss and loss of appetite
Family history of Lung Cancer
Coughing up blood or rust-
Radioactive ores such as colored sputum
uranium
Shortness of breath
Inhaled chemicals such as
arsenic, beryllium, cadmium, Feeling tired or weak
silica, vinyl chloride, nickel,
chromium, coal, mustard gas Infections such as bronchitis
and chloromethyl ethers and pneumonia that dont go
away or keep coming back
Air pollution
New onset of wheezing
Radiation therapy to the lungs
Horner syndrome
 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 Cancer of Unknown Primary is an estimate based on the course of the
disease taken from studying hundreds or thousands of people who have been diagnosed.

The prognosis for patients with Cancer of Unknown Primary is very poor. As a group, the median survival is
approximately 3 months with less than 25% and 10% of patients alive at 1 and 5 years, respectively.

Cancer of Unknown Primary is represented by a heterogeneous group of diseases all of which have presented
with metastasis as the primary manifestation. In each instance, distinct clinical and pathologic details require
consideration for appropriate, potentially curative, management.

Although only a minority of patients will have curable disease or a disease for which there is substantial
palliative benefit, the appropriate use of special diagnostic pathology will identify patients for whom directed
therapy will provide the best possible chance for response.

STATE OF THE ART IN CUP DIAGNOSIS

Current studies argue that to define a carcinoma as Cancer of Unknown Primary requires the patient to
present a histologically documented metastatic cancer, that is, a detailed health record with a thorough
physical examination including: pelvic and rectal exams; a blood test with complete biochemistry; an
urinalysis; a test for fecal occult blood; a review of the biopsy using immunohistochemistry; a chest
radiography; and an abdominal CT scan and/or a mammography, as appropriate.

All these diagnostic tests and complementary examinations to which will be submitted to the patient,
are intended to determining the primary tumor to be treated in the most suitable way, something that
unfortunately wont be achieved in most cases, which results in high stress levels, as well a very
substantial economic costs.

For this reason, in most cases the number of scans are limited to those that can provide a clinical benefit
to the patient, because currently, the treatment of patients with Carcinoma of Unknown Origin has a very
poor prognosis and provides meager profits, what recommends to focus all effors in determine which
chemotherapy scheme can provide the maximum benefit with minimal toxicity.
 DIAGNOSIS REVOLUTION
OncoCUP is based in a simple blood test that can detect Unknown Primary Cancer with 82.4% of
sensibility and 98.1% of specificity.

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

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

OncoCUP has been performed with data from 4.610 consecutive patients, then fine-tuned by other
research.
 WHY CHOOSE BIOPROGNOS TEST?
Innovative
Based on the combined count of AFP, -hCG, CA 15.3, CA 19.9, CA 72.4, CA 125, CEA, CYFRA, HE4,
NSE, ProGRP, PSA, fPSA, SCC and S100 Tumor Markers.

Non-invasive
First simple blood based test.

Accurate
Very high diagnostic capabilities: 82.4% Sensitivity and 98.1% Specificity.

Cost-effective
Solution to help in Unknown Primary Cancer diagnosis reducing the number of procedures that patients
have to undergo.

More complete
Besides Unknown Primary Cancer it also can determine the primary site.

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

FOR WHOM IS IT INTENDED?

Patients with paraneoplastic syndrome (a set of signs and symptoms that is the consequence of cancer
in the body but that, unlike mass effect, is not due to the local presence of cancer cells).

Patients with cancer found in one or more metastatic sites but the primary site cannot be determined.
 USES AND PURPOSES
Confirm or discard malignancy from results obtained previously with other tests, such as Computed
Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) findings thanks higher Sensitivity and
Specificity than imaging procedures.

Guide treatment decisions (such as decide whether to add or immunotherapy after surgery and/or
radiation therapy), therapy monitoring (doctors may use changes in the presence or amount of one or
more Tumor Markers to assess how the cancer is responding to treatment) and predict or monitor for
recurrence (looking for changes in the amount of a Tumor Marker may be part of their follow-up care
plan and may help detect a recurrence sooner than other methods).

INTERPRETATION OF RESULTS
Once the blood is analyzed and the Tumor Marker values are calculated, a final report wirh the probability of
finding Unknown Primary 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 Unknown Primary 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 Unknown Primary 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 Unknown Primary Cancer.

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

Improving clinical outcomes and quality of life

Bioprognos SL
Milanesat, 12
08017 Barcelona, SPAIN

www.bioprognos.com
support@bioprognos.com