All Press Releases for May 14, 2018

Bioprognos Announces OncoCUP Dx, a Blood Test that Can Identify Up to 30 Different Cancer Types

This innovative, non-invasive, accurate, and cost-effective test will aid doctors to find a possible malignancy in less time as well as save unnecessary explorations that patients should currently undergo when unspecific symptoms and signs.



All the knowledge acquired during the development of OncoCUP Dx will serve for one of the most promising tests in which BIOPROGNOS is also working and that is focused on cancer screening.

    BARCELONA, SPAIN, May 14, 2018 /24-7PressRelease/ -- BIOPROGNOS (www.bioprognos.com) announces the new version of OncoCUP Dx, an innovative, non-invasive, accurate, and cost-effective test specially designed for Cancer Unknown Primary diagnosis, that can identify up to 30 different cancer types, from a simple, cheap and quick blood test.

OncoCUP Dx has been developed and tested in collaboration with few Quick Diagnosis Units (QDUs) ―an effective alternative to conventional hospitalization specially designed to reduce delays in diagnosing potentially severe disease, such as cancer―. QDUs reduce costs without lowering the quality of diagnostic practice or patient care, and free acute-care beds for patients in need of treatment and are based on an urgent first visit, followed by the preferential scheduling and coordination of complementary tests and subsequent visits until a diagnosis is made. The main diagnostic tests and final diagnosis in QDUs are normally performed within 7 days after the first visit. The objectives of this QDU operation are: Diagnose early potentially severe diseases such as cancer; Avoid unnecessary hospitalization; Avoid hospital morbidity; Reduce health costs; Improve patient satisfaction; Allow patients and their families to continue occupational and personal life; Reduce emergency department workload; and Free up hospital beds.

In this way, the following signs and symptoms suggest the presence of Paraneoplastic Syndrome, suspicious of Advanced Neoplasia and/or Cancer of Unknown Primary: A cough that does not go away or gets worse; Chest pain that is often worse with deep breathing, coughing, or laughing; Hoarseness; Loss of appetite; Coughing up blood or rust-colored sputum; Shortness of breath; Feeling tired or weak; Infections such as bronchitis and pneumonia that don't go away or keep coming back; New onset of wheezing; or Horner syndrome.

These all symptoms and signs are not specific (such as breast or testicular masses) so before to referred patients to evaluate by the appropriate medical specialist, some diagnostic tests need to be performed: Analytical and Microbiological Tests; Simple Radiology (X-Ray); Computed Tomography (CT); Echography; Nuclear Scintigraphy; Digestive Endoscopy; Biopsies and Lymph Node Fine-Needle Puncture Aspiration (FNPA).

For all these group of patients, OncoCUP Dx can find in a quick way if all these symptoms and signs are produced by any of the 30 cancers that currently OncoCUP Dx can identify. The complete list of cancers that OncoCUP Dx can already distinguish is: Bladder Cancer, Breast Cancer, Cervical Squamous Cancer, Colorectal Cancer, Digestive Tract Tumor, Endometrial Tumor, Gastric Cancer, Gynecological Malignancy, Liver Cancer, Lung Cancer, Lymphoma, Malignant Melanoma, Medullary Thyroid Cancer, Neuroendocrine Tumor, NSCLC, NSCLC (Adenocarcinoma), NSCLC (Squamous), Other Squamous Tumors, Ovarian Cancer, Ovarian Epithelial Tumor, Ovarian Germ Cell Tumor, Ovarian Mucinous Tumor, Ovarian Sex Cords-Stromal Tumor, Pancreatic Cancer, Prostate Cancer, Sarcoma, SCLC, Testicular Cancer, Trophoblastic Tumor and Urological Cancer, something that will help doctors and healthcare professionals to find the primary site in less time as well as save unnecessary explorations that patients should currently undergo, by focusing in OncoCUP Dx primary site suggestions.

BIOPROGNOS has developed this innovative test thanks to a worldwide multicenter pilot trial with few hospitals and medical centers involved. In this way, BIOPROGNOS will continue this worldwide multicenter trial open on 2018 and 2019 by adding new hospitals from countries such as Argentina, Brazil, Colombia, France, Dominican Republic, Germany, Ireland, Italy, Mexico, Moldova, Poland, Portugal, Romania, Russia, Spain, United Kingdom or United States ―where the company is working in a Dual 510(k) and CLIA Waiver by Application (Dual Submission) for in vitro diagnostic (IVD) to market all company's tests in this country―, among others, to reach up to 20.000 total patients to get, if possible, a greater accuracy (currently between 97.00% and 99.00% for the cancers stated above), as well as including also other cancer types and subtypes, such as Angiosarcoma, Hemangiosarcoma, Hepatoblastoma, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Papillary Thyroid Cancer or Renal Cell Carcinoma, among others, with the goal in always providing the best tool for doctors and healthcare professionals to take the best decisions.

The total cost of the whole trial is about 3 Million Euros and, till now, it has been financed both the company as well as the medical centers involved, by signing several co-ownership agreements based on royalties from company's total net sales to these centers. BIOPROGNOS will publish part of the results (keeping some as trade secret), in next months in a peer review journal, after all final revisions and validations will be performed.

To conclude, add that all the knowledge and experience acquired during the development of the new version of OncoCUP Dx will serve for one of the most promising tests in which BIOPROGNOS is also working and that is focused on cancer screening (instead of diagnosis or confirmation of diagnosis, as all the company's tests are). BIOPROGNOS will present in scoop an advance of this new test in the United States, coinciding with the participation of the company in the Barcelona Ventures' accelerator program that will take place in the Silicon Valley next June.

About BIOPROGNOS
BIOPROGNOS is a Spanish biotechnology company focused in the development of innovative, non-invasive, accurate, and cost-effective cancer diagnostics tests. The current product portfolio consists of several tests to help doctors in cancer diagnosis after a suspicious image finding that should be biopsied in order to confirm or discard malignancy, such as OncoBREAST Dx (for Breast Cancer), OncoLUNG Dx (for Lung Cancer), OncoOVARIAN Dx (for Ovarian Cancer), OncoPROSTATE Dx (for Prostate Cancer) and OncoCUP Dx (for Cancer Unknown Primary). All current tests are already certified with CE Declaration of Conformity to be market in Europe as well as other countries.

Besides, BIOPROGNOS is currently working with other Certification Agencies such as ANVISA (Brazil), INVIMA (Colombia), CDSCO (India), Roszdravnadzor (Russia) as well a Dual 510(k) and CLIA Waiver by Application (Dual Submission) for IVD (United States of America).

Moreover, BIOPROGNOS is also working in other tests such as OncoCOLON Dx (for Colorectal Cancer), OncoLIVER Dx (for Liver Cancer) and OncoHENE Dx (for Head and Neck Cancer), among other, that are expected to be launched in next months.

Finally, all BIOPROGNOS tests are currently available in more than 50 countries through the main clinical laboratories.

About BARCELONA VENTURES
Barcelona Ventures (www.barcelonaventures.com) is a cross-border accelerator (Barcelona - Silicon Valley) which works with early-stage Spanish tech companies and accelerates them in the US market. They are running a 7-week Acceleration Program with American mentors and industry experts who enable Barcelona startups to enter the US market and prepare them to raise capital in the San Francisco Bay Area.

Barcelona Ventures is giving access to Silicon Valley funding from the city of Barcelona. Their focus is on helping early-stage Barcelona tech companies access the US market and investors through their acceleration program and incubation in Silicon Valley. Also, they provide legal counsel, meetings with investors and Demo Days.

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Anna Betoret
Bioprognos
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Spain
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