July 30, 2014 1:39 PM ET

Healthcare Equipment and Supplies

Company Overview of Predictive Biosciences, Inc.

Company Overview

Predictive Biosciences, Inc. develops novel molecular diagnostic cancer assays and provides urology-focused anatomic pathology laboratory products and services. It develops Clinical Intervention Determining Diagnostic and Multi-Analyte Diagnostic Readout approaches for cancer management by combining its novel clinical approaches and biomarkers. The company also offers CertNDx tests, a line of cancer assays enabling physicians to non-invasively determine the absence of cancer in patients with high negative predictive value, including CertNDx Molecular Grading Assay, a molecular diagnostic and prognostic information for bladder cancer; and CertNDx Bladder Cancer Assay, a non-invasive urine bas...

128 Spring Street

400 Level

B Annexure

Lexington, MA 02421

United States

Founded in 2006

Phone:

781-402-1780

Fax:

781-402-1785

Key Executives for Predictive Biosciences, Inc.

Chief Executive Officer and Director
Age: 61
Co-Founder and Chairman of the Scientific Advisory Board
Co-Founder
Co-Founder
Co-Founder and Chief Technology Officer
Age: 55
Compensation as of Fiscal Year 2014.

Predictive Biosciences, Inc. Key Developments

Predictive Biosciences Announces Partnership with ARUP Laboratories

Predictive Biosciences, Inc. announced a partnership with ARUP Laboratories, Inc. to offer the company's molecular diagnostic bladder cancer tests to ARUP's national network of clients. Through a non-exclusive agreement, ARUP will offer Predictive's CertNDx(TM) Bladder Cancer Assays in its comprehensive test menu to hospitals, healthcare providers, academic medical centers and military and government facilities around the country. ARUP's clients will be able to order CertNDx testing, submit samples and receive all results through ARUP. Predictive Biosciences will run the diagnostic testing in its CAP and CLIA-certified laboratory. The CertNDx Bladder Cancer Assay is a non-invasive, urine-based test to assess patients with hematuria and to monitor for bladder cancer recurrence post treatment. The test's unique approach stratifies patients based on their likelihood of bladder cancer and is highly accurate across all stages and grades of bladder cancer. CertNDx testing is also available in a tissue-based prognostic test for molecular grading that can provide a quantitative molecular assessment of tumor grade including the likelihood of disease progression.

Predictive Biosciences Announces Executive Changes

Predictive Biosciences announced the appointment of Pierre Cassigneul as the company's new chief executive officer. Mr. Cassigneul is a seasoned executive with more than 25 years of commercial experience in the healthcare and molecular diagnostic industries. He brings significant international and product commercialization experience to Predictive Biosciences, having held top management positions at several global diagnostics companies. Mr. Cassigneul replaces Marc Schneebaum, who will return to his original role as chief operating officer. Mr. Cassigneul previously served as vice chairman of the board and president and chief executive officer of XDx Inc.

Predictive Biosciences, Inc. Announces Next-Generation Sequencing Assay for p53

Predictive Biosciences, Inc. announced that it has developed a new next-generation sequencing (NGS) assay for the TP53 gene (encoding the p53 protein) that will enhance the clinical performance of its bladder cancer assay. The new CertNDx(TM) Bladder Cancer Assay incorporating TP53 is expected to be commercially available in early 2013. Predictive's next-generation sequencing assay for TP53 can detect 133 different mutations previously identified in bladder cancers. A research study conducted on 200 control samples and 36 cancers, incorporating TP53 sequence analysis into the existing assay, demonstrated an improvement over the previously published test by increasing sensitivity across bladder cancer pathways while retaining very high specificity and high Positive Predictive Value (PPV). The performance of this assay will also be validated in a large, prospective clinical trial to be completed in the first quarter of 2013.

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