Toxoplasma – Test Update

This will take effect August 4, 2014

Overview and Clinical Utility:

To improve performance and sensitivity of the Toxoplasma assay, PathGroup Labs will begin testing by Chemiluminescent Immunoassay for IgM Antibodies. The serological diagnosis of acute toxoplasmosis allows adequate treatment which reduces the risks of the disease both in immunocompromised patients and pregnant women.

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Maternal Serum Screen, Integrated – Test Update

This will take effect June 23, 2014

Overview and Clinical Utility:

Effective June 23, 2014, PathGroup will be insourcing maternal serum screening, integrated, to evaluate the risk for Down’s syndrome, Trisomy 18 and Open Spina Bifida. First specimen should be collected in the first trimester between 11 weeks and 13 weeks 6 days and Crown-Rump length (CRL) must be 4.2-8.5 cm. The second specimen should be collected in second trimester between 15 weeks and 18 weeks 6 days (optimal collection time frame) but can be collected until 21 weeks 6 days. Preliminary report after the first specimen will only have PAPP-A with final interpretation pending second specimen submission.

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Maternal Screen Testing Recalculation Request Form

Maternal Serum Screen Patient Information Form

Trichomonas Vaginalis By Aptima – Test Update

This will take effect June 9, 2014

Overview and Clinical Utility:

PathGroup is pleased to announce the immediate availability of the FDA-approved APTIMA Trichomonas vaginalis detection assay by Hologic. Trichomonas vaginalis is the most common curable sexually transmitted disease (STD) agent in the United States, with an estimated 7.4 million new cases occurring annually. Infections in women cause vaginitis, urethritis, and cervicitis. Discharge and small hemorrhagic lesions may be present in the genitourinary tract.

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Urine Protein Electrophoresis – Test Update

This will take effect May 19, 2014

Overview and Clinical Utility:

Effective May 19, 2014, PathGroup will implement in-house testing for Urine Protein Electrophoresis (UPE). Protein electrophoresis is a well-established technique routinely used for the screening of protein abnormalities. Urine protein electrophoretic patterns can classify proteinuria as glomerular, tubular, combined, stress or normal.

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GenoSpace Named Best of Show Winner at Bio-IT World 2014

Thomson Reuters, PathGroup and GenoSpace collaborate to deliver advanced personalized medicine assays and reports to oncologists.

CAMBRIDGE, MA, – (May 8, 2014)GenoSpace today announced that the company was named a Best of Show grand prize winner at the 2014 Bio-IT World Conference and Expo. GenoSpace for Clinical™ was recognized in the Web-Based Services and Software category for its comprehensive suite of offerings supporting genomic medicine.

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HIV Confirmatory Testing – Test Update

This will take effect April 28, 2014

Overview and Clinical Utility:

PathGroup Labs will begin confirmatory testing for a positive HIV screen utilizing the Bio-Rad MultiSpot HIV1/HIV2 discriminatory assay and will discontinue confirmatory testing by Western Blot effective April 28, 2014. It is strongly recommended that patients whose positive screen is followed by a negative confirmatory assay be tested by Nucleic Acid Testing.

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HIV Confirmation Screening Algorithm

Celiac Disease Panel – Test Update

This will take effect April 14, 2014

Overview and Clinical Utility:

Effective April 14, 2014, PathGroup will change methodologies for the celiac disease panel (tissue transglutaminase and deaminated gliadin IgA and IgG). Methodology will change from enzyme immunoassay to multiplex flow immunoassay.

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Anti-Phospholipid Antibodies – Test Update

This will take effect April 14, 2014

Overview and Clinical Utility:

Effective April 14, 2014, PathGroup will be changing methodology for cardiolipin antibodies IgA, IgG and IgM from enzyme immunoassay to multiplex flow immunoassay. We will also insource Beta-2 Glycoprotein IgA, IgG and IgM using multiplex flow immunoassay.

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Maternal Screen AFP Only 2.5 MoM Cut-Off – Test Update

This will take effect March 24, 2014

Overview and Clinical Utility:

Effective March 24, 2014, PathGroup will insource the maternal screen for Open Spina Bifida Only with a 2.5 MoM (multiple of the median) cut-off. This screen is used to evaluate the risk for open spina bifida. Specimen should be collected in the second trimester between 14 weeks and 21 weeks 6 days.

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PathGroup Announces Expansion of Its SmartGenomics Offering to Include Profiling of Hematologic Malignancies

BRENTWOOD, Tenn. (March 17, 2014)PathGroup, one of the largest private providers of pathology services in the United States, today announced launch of the SmartGenomics™ Heme Profile, which provides genomic profiling and information for patients that have failed or been unsuccessful on repeated therapy for the group of cancers that include leukemias, lymphomas and myeloproliferative/myelodysplastic diseases.  The newly launched offering is based on collaboration between PathGroup, GenoSpace and the IP & Science business of Thomson Reuters.

The SmartGenomics™ Heme Profile includes Next-Generation DNA Sequencing (NGS) of 77 clinically actionable genes mutated in hematolymphoid cancers and is complemented by Array-based Comparative Genomic Hybridization (aCGH) for whole genome level identification of chromosomal copy number changes and loss of heterozygosity (LOH).  Results provide the treating oncologist with prognostic, predictive, and therapeutic information, as well as available clinical trial options.

Prevalence estimates from the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review1, indicate that there are approximately one million individuals in the country that are living with a diagnosis of Hodgkin disease, leukemia, multiple myeloma, or Non-Hodgkin lymphoma, in addition to myeloproliferative/myelodysplastic diseases.  Up to 50% of these diseases ultimately are refractory to treatment.  Furthermore, many of these malignancies are increasing in incidence and pose a significant health care burden.

“When PathGroup committed to providing genomic profiling to community oncologists and researchers, we understood early in the development process that independent interrogation of cancers originating in the bone marrow, blood, and lymphatic system, would be an imperative complement to any exploration of solid tumors,” stated Ben Davis, MD, Chairman, President and CEO of PathGroup.  “As was the case when we released SmartGenomics for solid tumors, we will continue to rely on the exceptional data aggregation and reporting that GenoSpace and Thomson Reuters afford PathGroup in modeling a best-in-class precision oncology offering.”

“The GenoSpace team has been honored to work with PathGroup and is impressed with their approach to developing an integrated personalized medicine offering,” said John Quackenbush, PhD, CEO of GenoSpace. “We are pleased to see PathGroup expand its use of the GenoSpace FullView™ platform to integrate and interpret complex genomic, clinical and demographic information to benefit patients with hematologic malignancies.”

Further, Joseph Donahue, senior vice president, Thomson Reuters Life Sciences commented, “Thomson Reuters is committed to collaborating with innovative organizations like PathGroup and GenoSpace to deliver valuable, new solutions for Life Science clinicians.  The latest phase of our work with these partners, in providing patient-specific genomic intelligence for stratifying cancers, is rooted in the high quality, curated content in Cortellis™, and brings us closer to finding more precise treatments and therapies for oncology patients, regardless of their tumor type or disease.”

1 Howlader N, Noone AM, Krapcho M, Garshell J, Neyman N, Altekruse SF, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Cho H, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2010, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2010/, based on November 2012 SEER data submission, posted to the SEER web site, April 2013.

About PathGroup

Founded in 1965, PathGroup has evolved into a premier provider of anatomic, clinical and molecular pathology services. Privately held and physician centric, PathGroup works seamlessly with customers to provide superior diagnostic services – a vital link in the cycle of patient relationships.  PathGroup uses the latest in proprietary and industry standard technology to deliver fast, accurate results. The company provides clients with the highest quality of services available, consistently exceeding the expectations of physicians, employees, payers and most importantly, patients. One Lab; Total Service. For more information, visit www.pathgroup.com.

About GenoSpace

 At GenoSpace, we are Digital Architects of Genomic Medicine™. GenoSpace is a Cambridge, Massachusetts-based company that has developed robust software systems for securely storing vast amounts of genomic and health data, and providing it in formats specific to its diverse user communities. GenoSpace for Clinical Care facilitates clinically actionable interpretation and report generation for precision medicine. GenoSpace for Research provides dynamic analysis, visualization and collaboration tools. GenoSpace for Patient Communities enables patient-centric exploration and advancement of personalized medicine. Please visit www.GenoSpace.com for more information.

About Thomson Reuters

Thomson Reuters is the world’s leading source of intelligent information for businesses and professionals. We combine industry expertise with innovative technology to deliver critical information to leading decision makers in the financial and risk, legal, tax and accounting, intellectual property and science and media markets, powered by the world’s most trusted news organization. With headquarters in New York and major operations in London and Eagan, Minnesota, Thomson Reuters employs approximately 60,000 people and operates in over 100 countries. For more information, go to www.thomsonreuters.com.

CONTACTS

Daniel Meyer
GenoSpace, LLC
pr@genospace.com
(617) 520-4182

Laura Gaze
Thomson Reuters
laura.gaze@thomsonreuters.com
(203) 535-6283