Labcorp reports on genetic counselor pain points
June 2025—A Labcorp survey of more than 100 genetic counselors, including 15 hours of one-on-one conversations, found their three pain points to be balancing patient care and administrative demands, the financial difficulties that complex genetic testing presents, and staying on top of scientific and technologic advances in genetics.
Of the time constraints, one genetic counselor at a large health system said, “Anything a lab partner can do, from making their portal easier to get reports or having easy access to someone on their end to help me with some questions, all that gives me more time with the patient.”
One of the opportunities Labcorp identified from its findings is to integrate electronic health records and laboratory-driven digital tools. “As the role of genetics expands,” the report says, “healthcare systems must prioritize EHR integration and lab partnerships through networks like Epic Aura.”
The other opportunities identified are as follows:
- Enable coverage and cost transparency for genetic testing/counseling. Health systems and providers can address billing and coding challenges by implementing advanced software for accurate code selection and documentation, for example, and using standardized templates to improve medical necessity justification.
- Dedicate resources to continuing education in genetics. Health systems and providers can allow time for conference attendance, expert-led training sessions on genetic advances, and engagement with laboratories that offer posters, publications, and webinars on genetics.
A genetic counselor said: “Many of the physicians I work with depend on our team to stay abreast of rapid advancements in the testing capabilities. The physicians don’t have the time and are managing so many other things, so we become their resource.”
FDA approves Ventana MET (SP44) RxDx assay as CDx
The Food and Drug Administration approved the Ventana MET (SP44) RxDx assay, the first companion diagnostic approved to aid in determining MET protein expression in non-small cell lung cancer patients. These patients may now be eligible for treatment with AbbVie’s c-Met-targeted therapy Emrelis (telisotuzumab vedotin-tllv).
The FDA accelerated approval is supported by data from the phase two LUMINOSITY study, an ongoing study designed to characterize the efficacy and safety of Emrelis in c-Met overexpressing advanced NSCLC.
FDA clears Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test
The Food and Drug Administration granted 510(k) clearance for Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic test for assessing amyloid pathology in patients evaluated for Alzheimer’s disease and other causes of cognitive decline.
The test is a minimally invasive measurement of pTau 217 and β-amyloid 1-42 concentrations in plasma as a proxy for the presence of β-amyloid plaque pathology in the brain. It is intended for use in adult patients ages 50 and older who present at a specialized care setting with signs and symptoms of cognitive decline. In a clinical study population of 499 patients, which closely mirrored the U.S. demographics, and when applying a dual cut point, the test demonstrated a positive predictive value of 92 percent and a negative predictive value of 97 percent.
The ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), which the FDA authorized for use in CSF in 2022.
AI-driven CDx granted breakthrough designation
The Food and Drug Administration granted breakthrough device designation for the Ventana TROP2 (EPR20043) RxDx device. Roche reported it is the first breakthrough device designation to be granted for a computational pathology companion diagnostic device.
The Ventana TROP2 (EPR20043) RxDx device consists of the TROP2 algorithm, Navify digital pathology image management system, Roche digital pathology scanners (DP 200, DP 600), and the Ventana TROP2 (EPR20043) RxDx assay used with the OptiView DAB Detection Kit for staining on a BenchMark Ultra IHC/ISH instrument. The RxDx device analyzes whole slide images of non-small cell lung cancer tissue stained with TROP2 to compute a quantitative TROP2 score.
The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring.
The device is indicated as an aid in identifying patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alteration most likely to benefit from treatment with Daiichi Sanko and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk).
No FDA appeal on LDT final rule
The Food and Drug Administration will not appeal the U.S. District Court’s recent ruling that vacated the final rule on laboratory-developed tests.
The final rule that would have regulated LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act was vacated in March when the U.S. District Court for the Eastern District of Texas ruled in favor of the laboratory plaintiffs in two consolidated cases.