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Caveats on use of SARS-CoV-2 PCR Ct values in clinical practice

May 2021—In an April 21 blog post, the Association for Molecular Pathology advised against routine use of SARS-CoV-2 PCR cycle threshold values to inform clinical decisions.

Blake W. Buchan, PhD, D(ABMM), author of the post and associate professor in the Department of Pathology, Medical College of Wisconsin, explains the key considerations related to the derivations, reliability, and reporting of Ct values. He is a member of the AMP Clinical Practice Committee and was the AMP’s representative for its work with the Infectious Diseases Society of America on a joint statement on the use of SARS-CoV-2 PCR Ct values for clinical decisions (http://bit.ly/AMP-IDSA-statement).

Dr. Buchan writes in his post that the use of different specimen collection devices, specimen types, nucleic acid extraction methods, genomic targets, and RT-PCR chemistries all contribute to variability in the final reported Ct value.

He says reporting Ct values for public health or epidemiologic studies may be important to the research and understanding of SARS-CoV-2 infection and transmission, but he urges caution in reporting Ct values in the medical record. If such values are reported routinely or sporadically, he writes, “consideration should be given to inclusion of an interpretive comment that specifically states the test used and the lack of verification for use in individual patient care.”

The full post is at: http://bit.ly/AMP-​IDSA-Ct.

FDA OKs CDx to identify endometrial cancer patients for immunotherapy

The Food and Drug Administration approved the Ventana MMR RxDx Panel for advanced or recurrent endometrial cancer patients. Testing can identify patients eligible for treatment with Jemperli (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from Glaxo­Smith­Kline that was approved by the FDA on April 22.

The Ventana MMR RxDx Panel, a label expansion of Roche’s current on-market Ventana MMR IHC Panel, is a qualitative immunohistochemistry test intended for use in assessing mismatch repair proteins (MLH1, PMS2, MSH2, MSH6) in formalin-fixed, paraffin-embedded endometrial carcinoma tissue by light microscopy.

Illumina partners for TP53 companion diagnostic

Illumina and Kartos Therapeutics announced a partnership to co-develop a TP53 companion diagnostic based on the content of Illumina’s TruSight Oncology 500. This companion diagnostic for multiple hematologic indications will be the first to use the TSO 500 genomic profiling assay with peripheral whole blood as a diagnostic sample type.

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