CDx approved for patients with gastric and GEJ cancers
Roche received Food and Drug Administration approval in October for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer who may be eligible for targeted treatment with zolbetuximab (Vyloy). The Ventana Claudin 18 (43-14A) RxDx assay is an FDA-approved immunohistochemistry companion diagnostic for determining CLDN18 protein expression in tumors of patients with gastric or GEJ adenocarcinoma. Read article.
From the President’s Desk
There’s a shortage of physicians in the U.S.—across specialty areas and including pathology—and the reaction has been rather predictable: nonphysicians are pushing hard to fill those voids. Scope of practice is a major issue facing physicians today, and pathologists are no exception. In other specialties, we’ve seen nurse practitioners and physician assistants step up to take on more and more responsibilities that were once reserved for physicians. Read article.
Rethinking maternal AFP race adjustments
David Grenache, PhD, D(ABCC), chief scientific officer of TriCore, is breaking no new ground when he considers the maternal serum alpha-fetoprotein test and says, “A screening test is designed to put people into one of two camps.” No scientific advances there. But the reverberations of this particular screening test have landed patients and physicians in complicated situations of late. Read article.
FDA OKs Kisqali in people with HR+/HER2- early breast cancer
Novartis announced FDA approval of Kisqali (ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of people with HR+/HER2- stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease. The approval is based on results from the pivotal phase three NATALEE trial, which showed a significant and clinically meaningful 25.1 percent … Continue.
Pillar launches OncoReveal Nexus NGS assay
Pillar Biosciences has announced the global launch of OncoReveal Nexus, a research use only next-generation sequencing kit designed to assess key driver genes for hematological and solid tumor malignancies in one multiplex reaction. The assay can batch up to 81 patient samples in a single Illumina MiSeq sequencing run, using as little as 2.5 ng DNA per sample, and has a sample-to-report time of two to three days after DNA isolation. Continue.