Testing Guidelines at a Glance

New Definition for Abnormal Liver Chemistry
For the first time, the American College of Gastroenterology issued a practice guideline to define a healthy serum alanine aminotransferase (ALT) level. 'Normal' ALT (19 to 25IU/L for females 29 to 33 IU/L for males) is based on multiple studies correlating elevated ALT levels and liver-related mortality in populations worldwide. ALT levels above 25 IU/L in women and above 33 IU/L in men should be assessed by physicians.

"With the broad range of 'upper limit of normal' levels for ALT that vary from institution to institution, clinicians may not think to evaluate an ALT level of 70 IU/L, as this may be within the normal level for the reporting laboratory— even though this level of elevation is associated with increased liver-related mortality," explains guideline co-author Paul Y. Kwo, M.D., from Stanford University, in a statement. Additionally, the guidelines provide clinicians a step-by-step framework for the evaluation of elevated ALT.

Molecular Biomarkers for Colorectal Cancer
A joint guideline from the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology, published in the March issue of the Journal of Molecular Diagnostics establishes evidence-based recommendations for mutational testing of EGFR signaling pathways for patients with colorectal cancer (CRC), as well as key steps laboratories can take to operationalize CRC molecular testing.

A systematic literature review found evidence supporting mutational testing to guide therapy of CRC with anti-EGFR monoclonal antibodies. Mutations in BRAF and MMR have "clear prognostic value," while KRAS and NRAS have "relatively strong" evidence as negative predictors of benefit to anti-EGFR therapies. In addition to considerations for specific mutational analysis were recommendations for how laboratories can aid adoption of CRC molecular testing.

• Laboratories should use CRC molecular biomarker testing methods that are able to detect mutations with at least 5% mutant allele frequency.

• Laboratories should optimally utilize tissue specimens by using appropriate techniques (e.g., multiplexed assays).

• Laboratories must use validated CRC molecular biomarker testing methods with sufficient performance characteristics and must incorporate these methods into their overall laboratory quality improvement program.

• CRC molecular biomarker testing reports should include a results and interpretation section easily understandable by oncologists.

• It is suggested that 90% of reports be available within 10 working days from date of receipt in the molecular diagnostics laboratory.

• It is suggested that for laboratories requiring send-out testing, 90% of specimens should be sent out within 3 working days.

Update for Screening for Genital Herpes
An update on screening for genital herpes remains "consistent" with the previous 2005 U.S. Preventive Services Task Force (USPSTF) recommendations against routine serologic screening for genital herpes simplex virus (HSV) infection in asymptomatic adolescents and adults. The update, published in the Dec. 20, 2016 issue of the Journal of the American Medical Association, includes the recommendation to not screen asymptomatic, pregnant women.

"Based on the natural history of HSV infection, its epidemiology, and the available evidence on the accuracy of serologic screening tests, the USPSTF concluded that the harms outweigh the benefits of serologic screening for genital HSV infection," the task force writes.