September 02, 2014 8:53 PM ET

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Company Overview of Precision Therapeutics, Inc.

Company Overview

Precision Therapeutics, Inc., a life-science company, develops and delivers a portfolio of products to guide physicians and patients with difficult clinical decisions throughout the cancer care continuum. It provides ChemoFx, a drug response marker that measures an individual's malignant tumor response to a range of standard therapeutic alternatives under consideration by a physician; BioSpeciFx, which helps in determining the chemotherapies; and GeneFx Colon, a microarray-based gene signature. The company was founded in 1995 and is headquartered in Pittsburgh, Pennsylvania.

2516 Jane Street

Pittsburgh, PA 15203

United States

Founded in 1995

80 Employees

Phone:

412-432-1500

Fax:

800-549-6407

Key Executives for Precision Therapeutics, Inc.

Founder
Age: 54
Vice President of Operations
Chief Information Technology Officer
Age: 50
Vice President of Medical Policy/Payer Strategy
Compensation as of Fiscal Year 2014.

Precision Therapeutics, Inc. Key Developments

Precision Therapeutics, Inc. Receives Regulatory Approval of GeneFx(R) Lung Under CLIA

Med BioGene Inc. announced that its commercial partner, Precision Therapeutics, Inc. has received regulatory approval of GeneFx(R) Lung under CLIA (Clinical Laboratory Improvement Amendments of 1988), the United States federal regulations applicable to clinical laboratory testing. With this approval, Precision may undertake testing of GeneFx Lung in its CLIA-certified clinical laboratory in Pittsburgh, Pennsylvania. The evidentiary requirements of payors in the United States relating to the clinical utility of high-value molecular diagnostic tests, which includes GeneFx Lung, has varied over the last couple of years as among the numerous Medicare contract administrators who make coverage determinations within their jurisdictions, and as among other third-party payors. Also, specific payors have recently declined coverage of some molecular diagnostic tests citing a lack of evidence of clinical utility in the submissions. In advance of the commercial launch of GeneFx Lung, Precision plans to engage in further dialogue with payors to better understand the current landscape and the specific needs of relevant payors as they apply to GeneFx Lung and will incorporate this into their launch strategy in order to ensure that efforts are aimed to provide clinical utility data that satisfies payors' requirements. As such, the timing of the commercial launch of GeneFx Lung will be established by Precision in light of these considerations.

Med BioGene Inc. Provides GeneFx(R) Lung Regulatory Update

Med BioGene Inc. provided an update on the regulatory approval process for GeneFx(R) Lung. MBI's commercial partner, Precision Therapeutics, Inc., plans to offer GeneFx Lung testing under CLIA (Clinical Laboratory Improvement Amendments of 1988), the United States federal regulations applicable to clinical laboratory testing. Precision GeneFx Lung is a proprietary gene expression-based test to improve upon staging for identifying those patients with early-stage non-small-cell lung cancer (NSCLC) who, following surgical removal of their tumor, are at higher and lower risks of mortality. In an initial study of patient specimens from the National Cancer Institute of Canada Clinical Trials Group JBR.10 trial, published in the Journal of Clinical Oncology, patients classified by GeneFx Lung as higher risk benefited from adjuvant chemotherapy, and those classified as lower risk did not benefit and may have experienced a detrimental effect from adjuvant chemotherapy. GeneFx Lung was subsequently validated in predicting patient mortality in four independent studies involving data from tumor specimens totaling 676 untreated early-stage NSCLC patients.

Precision Therapeutics Announces Encouraging Data from Ovarian Cancer Assay Study

Precision Therapeutics, Inc. has announced the data from clinical study titled, Evaluation of a Chemoresponse Assay as Both a Prognostic and Predictive Marker in the Treatment of Persistent or Recurrent Ovarian Cancer, supporting the predictive value of the ChemoFx chemoresponse assay in recurrent ovarian cancer. The ability of ChemoFx to function as a predictive marker of patient outcome in persistent and recurrent ovarian cancer was evaluated in cooperation with MD Anderson Cancer Center, Mayo Clinic and UPMC Magee Women's Hospital of Pittsburgh. Several approaches were used for estimating the assay's predictive value in 262 patients with recurrent epithelial ovarian cancer who were treated with one of 15 therapies. The assay's relative ability to predict progression-free survival for patients treated with a therapy for which they were considered to be sensitive (match) was compared to the average prognostic value of sensitivity to a randomly selected treatment (mismatch). Patients were classified based on assay results and clinical treatment, and the percentage of sensitive therapies was included in multivariate analysis. The assay result for 'match' was significantly associated with progression-free interval (hazard ratio (HR) =0.67, 95% CI=0.50-0.91, p=0.009). Based on repeated (3,000) simulations, the mean hazard ratio for 'mismatch' was 0.81 (95% range=0.66-0.98), suggesting that 'match' results were predictive of response to a specific treatment. Furthermore, while 47% of tumors were non-sensitive to all assayed therapies and 9% were sensitive to all, 44% displayed heterogeneity in assay results. Improved outcome was associated with administration of a sensitive therapy, regardless of homogeneous or heterogeneous assay responses across all of the assayed therapies, indicating that the value of ChemoFx for predicting outcome was not due to tumor biology alone. The association between assay result for administered therapy and progression-free survival remained statistically significant in multivariate analysis (HR=0.60, 95% CI=0.36-1.02, p=0.057), independent of the percentage of S therapies.

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