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This change will take effect January 19, 2015

Overview and Clinical Utility:

Effective January 19, 2015, PathGroup will insource 4th generation HIV testing. Compared to the 3rd generation HIV antibody-only test, the 4th generation HIV assay provides greater sensitivity due its ability to detect the p24 antigen and conventional HIV-1 and HIV-2 antibodies. The p24 antigen becomes elevated and detectable during the initial burst of viral transmission before an antibody response. The risk of contagion in individuals with an HIV infection is reported to be greater in early acute infections due to high viral load.

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January 13, 2015

Females and children under 13 years of age inherently produce lower testosterone levels than adult males. As a result, an alternative method with greater sensitivity for detecting lower levels of testosterone must be deployed. The preferred method for detecting lower levels of testosterone is by LC/MS. In an effort to ensure PathGroup clients are ordering the appropriate Testosterone assay based on a patient’s gender and/or age, please see the ordering information detailed below.

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This change will take effect January 12, 2015

Overview and Clinical Utility:

Effective January 12, 2015, PathGroup will launch updated report formatting and testing utilities to the current Lipid Panel, and introduce a new Advanced Lipid Profile to aid in the determination of cardiovascular risk factors. Pertinent reporting updates to the current Lipid Panel include cardiovascular risk assessment classification, LDL cholesterol patient history with trend analysis, and test results reduced to clinically relevant data as recommended by the 2004 ATPIII guidelines.

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December 18, 2014

Due to a nationwide manufacturer backorder of the Lyme disease assay, PathGroup is experiencing delays in patient testing for Lyme disease. We are working diligently with the Lyme assay manufacturer to receive the first kits that become available for production. Stability of all samples has and will be maintained during this delay. We apologize for any inconvenience this may cause you or your patients.

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On November 12, 2014, PathGroup Laboratories identified a consistent positive bias in CRP values of approximately 0.9 mg/dL. After thorough investigation, we found this number to be consistent across all values. We have corrected the problem and the bias no longer exists.

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Effective Immediately

PathGroup would like to partner with you in protecting your employees and others from unnecessary exposure during the current Ebola outbreak. Limiting the amount of handling of specimens obtained from patients with suspected Ebola virus disease (EVD) is critical.

Patients with known or suspected EVD should not be referred to a PathGroup Patient Service Center; nor should collection of any specimen types be performed by a PathGroup phlebotomist.

If you have specimens from patients that are being evaluated for EVD, providers must contact their local State Department of Health to expedite testing and prevent exposure to transportation personnel.

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This will take effect October 20, 2014

Overview and Clinical Utility:

PathGroup is pleased to announce the availability of the FDA-approved Roche cobas® HPV assay effective Monday, October 20. This high-risk HPV test will replace the current Digene Hybrid Capture 2 assay. The new test will be performed on the fully automated cobas® 4800 System, for delivery of trustworthy results with PathGroup’s industry-leading turnaround time.

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This will take effect September 2, 2014

Overview and Clinical Utility:

PathGroup is pleased to announce the availability of Microsatellite Instability (MSI) analysis by PCR (MSI). Microsatellite instability is a result of a deficiency in a specific type of DNA repair capability called Mismatch Repair (MMR). Cells deficient in MMR have a reduced capability of repairing certain types of damage that naturally occur in their DNA, specifically mismatched bases. This deficiency is apparent in the replication of microsatellite sequences. Such microsatellite sequences are typically replicated and maintain a constant number of repeats. In MMR-deficient cells, the number of repeats can increase or decrease. Tumors that display MMR show a change in the size of microsatellite sequences from those seen in non-neoplastic tissue and are said to display MSI.

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This will take effect August 25, 2014

Overview and Clinical Utility:

PathGroup has made changes to both the solid tumor and hematomalignancy panels performed via Next-Generation Sequencing (NGS) as a part of SmartGenomics™ orders.

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This will take effect August 11, 2014

Overview and Clinical Utility:

Beginning the week of August 11, 2014, PathGroup Laboratories will change from the current Access Total βhCG assay to the new Access Total βhCG (5th IS) assay. Pathgroup’s vendor for Human Chorionic Gonadotropin, Beckman Coulter, recently introduced Access Total 5th IS. The new Total βhCG (5th IS) calibrators are standardized to the World Health Organization (WHO) 5th International Standard (NIBSC Code 07/364). The Access Total βhCG assay is the first βhCG assay to be standardized to the highly purified WHO 5th International Standard.

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