September 26, 2016 2:11 PM ET

Healthcare Providers and Services

Company Overview of Miraca Life Sciences, Inc.

Company Overview

Miraca Life Sciences, Inc. operates clinical pathology laboratories that provide diagnostic services in the fields of dermatology, gastroenterology, hematology, and urology in the United States. It focuses on the development of a blood-based diagnostics platform to address unmet clinical needs in the gastrointestinal cancer spectrum that range from screening and diagnosis to prognosis and therapeutic guidance. The company also provides urologic pathology services, including microscopy and immunohistochemistry with integrated molecular diagnostic services; EoGenius test that helps diagnose and monitor patients with eosinophilic esophagitis; and UroVysion, a deoxyribonucleic acid-based urine t...

6655 North MacArthur Boulevard

Irving, TX 75039

United States

Founded in 1996

Phone:

214-277-8700

Fax:

972-331-3148

Key Executives for Miraca Life Sciences, Inc.

Interim Chief Executive Officer
Age: 46
Vice Chairman
Age: 51
Chief Financial Officer
Senior Vice President and General Counsel
Compensation as of Fiscal Year 2016.

Miraca Life Sciences, Inc. Key Developments

Miraca Life Sciences to Market Theradiag's LISA TRACKER® Range in US Market

Theradiag announced that four tests from its LISA TRACKER® range have been launched in the US market, under the licensing agreement with Miraca Life Sciences that was announced in November 2015. Miraca Life Sciences will start to market and promote four tests under the name “InformTx™” that utilize technology and raw materials from Theradiag's LISA TRACKER® range. These four biotherapy monitoring tests (Infliximab/Remicade®, Adalimumab/Humira®, Certolizumab/Cimzia® and Vedolizumab/Entyvio®) deal mainly with inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. The launch of InformTx™ by Miraca Life Sciences marks the first time that monitoring has been available in the US market for Certolizumab and Vedolizumab. Theradiag will sell the required materials and will receive royalties on Miraca Life Sciences' sales in the USA.

Miraca Life Sciences Launches InformTx Therapeutic Drug Monitoring for Four Biologic Drugs, Including Firsts for the United States

Miraca Life Sciences has expanded into clinical pathology testing with its launch of InformTx therapeutic drug monitoring (TDM) for patients with inflammatory bowel disease (IBD). The InformTx assays measure both drug and anti-drug antibody levels for infliximab (trade name Remicade), adalimumab (trade name Humira), certolizumab (trade name Cimzia), and vedolizumab (trade name Entyvio). The launch of InformTx marks the first time that TDM has been available in the United States for certolizumab and vedolizumab. Miraca Life Sciences licensed the technology and raw materials for InformTx from France-based Theradiag, which has offered these TDM assays in Europe for many years under the name LISA TRACKER. InformTx testing uses laboratory-validated ELISA technology. Unique for TDM in the United States, the InformTx report provides clinicians with quantitative test results, historical test result data, and guidance from the most up-to-date peer-reviewed scientific literature. Testing requires five to seven milliliters of peripheral blood in a serum separator tube, and the results are reported within five days. InformTx testing has been underway since May 2 with a few physician practices. The service is now available to all U.S.-based gastroenterologists.

Miraca Life Sciences Launches the EoGenius™ Test

Miraca Life Sciences has launched the EoGenius™ test which helps diagnose and monitor patients with eosinophilic esophagitis (EoE). Exclusively offered by Miraca Life Sciences, the test helps clinicians differentiate between eosinophilic esophagitis and other clinical and pathologic mimics, such as GERD. Endoscopy of patient with eosinophilic esophagitis with characteristic rings and furrows. Details of the EoGenius test: The EoGenius test helps diagnose and monitor eosinophilic esophagitis; The assay panel comprises a 96-gene quantitative polymerase chain reaction array and an associated dual algorithm that uses cluster analysis and dimensionality reduction; Biopsy tissue from proximal, middle, or distal locations of the esophagus may be used; Formalin-fixed, paraffin-embedded tissue or RNA-later-preserved tissue may be used from a single biopsy; EoGenius has been validated in both adult and pediatric populations; The EoGenius report provides a result of Positive, Negative, or Indeterminate (approximately 10%), based on the gene expression score produced by the EoGenius algorithm. In clinical practice, differentiation is difficult between eosinophilic esophagitis and other common causes of esophageal eosinophilia, such as GERD, and other causes of dysphagia. Patients may have a mismatch between symptoms and histopathologic features, which creates a need for multiple assessments.

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