Roche Seeks FDA Approval of Companion Lung Cancer Test

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August 4, 2015

ACMG Adds Overused Genetic Tests to the Choosing Wisely Campaign

By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies

The American College of Medical Genetics and Genomics (ACMG) has released a list of five commonly misordered genetic tests that patients and providers should discuss prior to ordering. The evidence-based recommendations are part of Choosing Wisely, a national, multidisciplinary campaign that encourages physicians to avoiding wasteful or unnecessary medical tests, treatments and procedures. Participation by ACMG signals acknowledgement that there is…

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CAP Accreditation Checklist Update Addresses LDTs

By Kelly A. Briganti, Editorial Director, G2 Intelligence

Proactively responding to the debate about laboratory developed tests (LDTs), the College of American Pathologists (CAP) has added new requirements relevant to LDTs to its accreditation checklists. On July 28, the CAP released enhanced Laboratory Accreditation Program checklists. The Centers for Medicare and Medicaid Services reapproved CAP's accreditation program…

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CareEvolve's outreach connectivity solutions exchange laboratory results and orders between the Laboratory Information System and provider's Electronic Medical Record (EMR/EHR) systems. In addition to industry leading interconnectivity, CareEvolve  includes a cloud-based Patient Results Portal, Provider Portal and data analytic functionality. The CareEvolve solutions are currently interfaced with over 300 EMR products and transfer orders and results for more than 30,000 providers.  For more information, visit www.careevolve.com or call 888-322-5222.


Roche Seeks FDA Approval of Companion Lung Cancer Test

By Ron Shinkman, Editor, Laboratory Industry Report

Pharmaceutical and testing giant Roche has submitted to the U.S. Food and Drug Administration a companion diagnostic for non-small cell lung cancer.
The assay, known as the cobas EGFR mutation test, would be used in conjunction with an AstraZeneca investigational therapy for lung cancer patients with an acquired mutation for…

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AACC Calls for Accuracy, Transparency in Direct-to-Consumer Testing

By Stephanie Murg, Managing Director, G2 Intelligence

With the market and media momentum of direct-to-consumer (DTC) testing showing no signs of slowing, the American Association for Clinical Chemistry (AACC; Washington, D.C.) issued a position statement on direct-to-consumer laboratory testing. Released to coincide with the organization's annual meeting, held July 26-30 in Atlanta, the statement calls for accuracy and transparency in DTC testing…

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