detect SARS-CoV-2 and related COVID-19 condi- tions is covering their labs’ costs, 21% of survey respondents said “yes” and 17% “no,” while more than half (54%) said they were “not sure.”


Diabetes testing


Among survey respondents testing for diabetes, their labs are using the following methodologies: • HbA1c: 88% (up from 79% in 2021) • Fasting plasma glucose test: 85% (up from 76% in 2021)


• Random plasma glucose test: 76% (up from 68% in 2021)


• Oral glucose tolerance test: 67% (up from 56% in 2021)


Those surveyed were also asked what methods of testing they used for HbA1c, one of the most com- monly used for diabetes management. Responses were as follows: • Immunoassay: 46% (up from 40% in 2021) • Enzymatic: 21% (up from 17% in 2021) • Cation exchange HPLC: 11% (down from 14% in 2021)


• Boronate affinity chromatography: 5% (up from 4% in 2021)


• Capillary separation: 4% (down from 5% in 2021)


Adoption of next generation sequencing (NGS) Only 7% of survey respondents said they conduct in-house NGS testing for cancer (down from 9% in 2021), but recent research shows increased interest in this modality given its ability to analyze genomic abnormalities in a cost-effective manner. The American College of Medical Genetics and


Genomics (ACMG) reports that “Next-generation sequencing (NGS) technologies are now established in clinical laboratories as a primary testing modality in genomic medicine…with advancements like DNA sequencing and RNA sequencing allow uncovering of genomic, transcriptomic, and epigenomic scenes of individual malignant growths.” 1 The ACMG says NGS technologies have made it “cost-effective to analyze an individual with disease- targeted gene panels, exome sequencing, or genome sequencing to assist in the diagnosis of a wide array of clinical scenarios.” Physicians ordering NGS tests for patients with breast cancer increased more than six-fold from 2014 to 2019, according to research published in the November 2021 edition of JCO Precision Oncology.2


Looking ahead


The results of the 2022 Disease Management State of the Industry survey show how U.S. clinical labs continue to innovate despite the challenges of ris- ing test volumes, supply chain disruptions, and staffing shortages. Many of the advancements being embraced,


from process automation to the use of diagnostic platforms to test for multiple conditions, benefit not only the patient in terms of more rapid and accurate diagnosis, but also the lab itself through greater efficiency and faster throughput.


REFERENCES


1. Rehder, C., Bean, L.J.H., Bick, D. et al. Next-generation sequencing for con- stitutional variants in the clinical laboratory, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021;23(8):1399-1415. doi:10.1038/s41436-021-01139-4.


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2. Sturgill EG, Misch A, Lachs R, et al. Next-generation sequencing of patients with breast cancer in community oncology clinics. JCO Precis Oncol. 2021;5:1297- 1311. doi: 10.1200/PO.20.00469.


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