Lab Report: September 2016


ADVANCE for Laboratory is pleased to introduce Lab Report, a monthly news briefing designed to highlight recent news in the clinical laboratory industry. As champions for clinical labs, we want to spread news about the great work being done in healthcare facilities and clinical settings throughout the United States.

Check back often to find out about award winners, staff and manager promotions, facility expansions, policy and regulatory updates, association news and more. We hope you will share this content with your fellow MLPs, managers and friends.

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James Liggins

James Liggins, Chief Executive Officer of CRI

CRI Receives Cooperative Agreement Award to Improve Waived Testing Practices

COLA Resources, Inc. (CRI), the educational subsidiary of COLA, recently announced that it was awarded a $1.5 million grant from the Centers for Disease Control and Prevention (CDC) to improve waived testing performance and outcomes at Certificate of Waiver (CW) sites nationwide. The five-year project is intended to support and expand the efforts of stakeholder partners such as the CDC, the Centers for Medicare and Medicaid Services (CMS) and others to instill quality practices and recommendations at CW sites in order to improve patient safety and health outcomes.

As part of the grant project, CRI will:

  • Develop and/or expand systems, including a special information portal, which will include information on regulatory requirements and good laboratory practices; training/ educational materials; and quality improvement (QI) tools and resources
  • Conduct assessments on practices and waived testing performance in CW sites to identify areas needing improvement
  • Increase CW sites’ participation in quality assessment and QI activities


Zika Virus

Zika Vaccine Development Receives Big Boost By Innovate UK

The further development of a promising Zika vaccine candidate by Themis Bioscience has received a strong support by the United Kingdom’s innovation agency, Innovate UK. In the past twelve months, Themis identified several suitable validated Zika antigens for the development of the vaccine. The company’s team had tested a number of candidate vaccines in animal models, and has already initiated a toxicity study and GMP manufacturing. The main part of the program supported by Innovate UK is the Phase 1 clinical trial, as well as the development of a thermostable formulation for the vaccine. One of the major advantages of the Zika vaccine candidate of Themis is a validated as well as cost-efficient production process. The measles vector technology developed by Themis forms the basis of all current vaccine candidates advanced by the company. It allows a rapid upscaling of the very cost-effective vaccine production process once the vaccine candidate has been determined. This ability is critical for a vaccine that is supposed to combat diseases such as Zika from spreading in highly populated areas.

Pathologist Using the Cernostics Platform / Mike Hoerres, CEO of Cernostics

Pathologist Using the Cernostics Platform

Mike Hoerres

Mike Hoerres, CEO of Cernostics

UPMC Partners with Cernostics to Pursue ‘Precision Medicine’

As part of its wide-ranging efforts to better target treatments to patients while reducing unnecessary tests and procedures, UPMC announced recently that it is investing in and partnering with Cernostics, an oncology diagnostics company whose unique technology enables so-called “precision medicine.” Current pathology testing is a largely manual and subjective process, with pathologists studying tissue and tumor samples under a microscope. The information produced by Cernostics TissueCypher platform can be used to provide physicians and patients with individualized, actionable scores indicating diagnosis, prognosis or response to therapy. This test could enable early intervention to prevent cancer in high-risk patients, and spare low-risk patients frequent and unnecessary endoscopies and treatments. Working together, UPMC and Cernostics hope to use TissueCypher to develop additional novel tests, beyond gastrointestinal conditions.

Howard Goldman, MD

Howard Goldman, MD, professor and vice chair of Glickman’s Quality and Patient Safety program

Eric Klein, MD

Eric Klein, MD, chairman of the Glickman Urological & Kidney Institute

Cleveland Clinic Joins National Registry to Benefit Prostate Cancer Patients

Cleveland Clinic’s Glickman Urological & Kidney Institute and Cleveland Clinic Florida have joined the American Urological Association’s Quality (AQUA) Registry, a national clinical registry designed to measure and report healthcare quality and patient outcomes in urology. Urologists at both locations will be working with the AQUA Registry to collect and track patients’ demographics, comorbidities, treatments and outcome information, enabling comparative effectiveness research on the association between treatment and outcomes. According to the Centers for Medicare & Medicaid Services, the AQUA Registry qualifies as a specialized registry within the “Meaningful Use” Electronic Health Record (EHR) Incentive Program and is the only specialty-wide urologic registry that can generate national benchmarks. Through the aggregation and organization of clinical- and patient-reported data on diagnostic and therapeutic interventions, outcomes and resource utilization, the registry will provide the urologic community with a definitive resource for informing and advancing urology care within the United States.

Dont Wait Vacinate

Don’t Wait Vaccinate Campaign

‘Don’t Wait. Vaccinate.’ Campaign Reminds Parents to Update Children’s Vaccines

Recently, the Department of Health, in partnership with the departments of Education and Insurance, continued the “Don’t Wait. Vaccinate.” campaign by hosting an immunization clinic and encouraging parents to add immunization updates to the list of things children need before their first day of school. Children in grades K-12 needed the following immunizations for attendance: tetanus, diphtheria, polio, MMR (measles, mumps, rubella), hepatitis B and chickenpox. Children entering the seventh grade also needed additional immunizations of meningococcal conjugate vaccine (MCV) and tetanus, diphtheria, acellular pertussis (Tdap). All of the vaccines listed were available at back-to-school clinics the Department of Health held in Pennsylvania through September 2nd, 2016. The clinics provided immunizations at little or no cost for children through 18 years of age who were Medicaid eligible, uninsured, underinsured or American Indian or Alaska Native.



ISCT Calls for Changes to Proposed U.S. REGROW Act on Cell Therapies

The International Society for Cellular Therapy (ISCT), a global society of clinicians, researchers, regulatory specialists, technologists and industry partners dedicated to the translation of cellular therapy into safe and effective therapies , recently announced its reasons for opposition to the current version of the REGROW Act-the U.S. government’s legislative efforts to promote faster patient access to effective new cellular therapies. ISCT supports, and has undertaken decades of activity with regulators in legislative efforts that seek to increase availability and financial accessibility of cell therapies without compromising either safety or efficacy. In addition, ISCT has also supported progress through appropriate fast track treatments, breakthroughs and accelerated approvals, as well as patient-focused tools. These all play a key role in addressing unmet medical needs. However, ISCT has identified a number of key features of the legislation that fail to address or provide clarity that will be needed to provide affordable and accessible treatment to patients. As a result, ISCT cannot support the current proposed legislation and strongly calls for a redraft to address these concerns.


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