Logistics and laboratory effectiveness survey
May 2025—Ninety-nine percent of laboratory professionals say medical couriers impact their work in a “typical week,” with 81 percent of respondents who work in acute care labs indicating the impact is “significant,” according to a CAP TODAY survey sponsored by MedSpeed.
Of the 318 laboratory professionals who responded to the 2025 CAP TODAY survey, 84 percent said that in the last month a medical courier delay or error impacted their ability to provide appropriate and timely results for patients, with an average of three such incidents reported per month per respondent. Fifty-six percent of laboratory directors, managers, and supervisors indicated that a courier error compromised an irreplaceable specimen in the last year, with an average of two such incidents reported per respondent per year. And 83 percent of laboratory directors, managers, and supervisors said courier reliability affects their decision to partner with specialty labs or complementary labs for send-out and referral testing.
The survey also found that 48 percent of laboratory professionals have stayed late to wait for the courier to arrive, 41 percent have had to request stat service to supplement untrustworthy scheduled service, and 36 percent have transported or shipped specimens themselves.
CAP TODAY conducted the survey from Jan. 14 to 22.
Test cleared as companion diagnostic for Qfitlia
The FDA cleared Siemens Healthineers’ Innovance Antithrombin assay for a new claim allowing its use as a companion diagnostic test for people treated with Qfitlia (fitusiran), a Sanofi hemophilia therapy. The blood test will aid in monitoring antithrombin activity to support Qfitlia dosing in adult and pediatric patients ages 12 and older. Siemens Healthineers reports it is the only assay cleared for this indication.
Paige PanCancer Detect designated a breakthrough
The Food and Drug Administration granted breakthrough device designation to Paige PanCancer Detect, an AI-assisted diagnostic application. Paige reports it’s the first designation of its kind for an AI-enabled tool capable of identifying both common cancers and rare variants from different anatomic sites.
Coverage for OncoReveal
Pillar Biosciences received nationwide Medicare coverage for its OncoReveal CDx pan-cancer solid tumor in vitro diagnostic next-generation sequencing kit. The kit uses Pillar’s proprietary SLIMamp (Stem-Loop Inhibition-Mediated amplification) technology for detection of single nucleotide variants, insertions, and deletions in 22 genes using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens.
OncoReveal CDx has also been approved as a companion diagnostic to identify patients who may benefit from EGFR TKI therapy (class approval) in non-small cell lung cancer and Erbitux and Vectibix for KRAS in colorectal cancer. It has been FDA cleared on the Illumina MiSeq Dx. It is reported to payers using the Proprietary Laboratory Analysis CPT code 0523U.