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The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
The company's approach involves using both fluorescence in situ hybridization and next-generation sequencing to provide clinicians with information.
The team will present the results to the US Food and Drug Administration as part of a 510(k) application in order to commercialize the technology with Biofluidica.
The company said that diagnostic testing volumes, product and royalty revenues, and clinical services revenues all fell year over year.
The FDA granted de novo classification for eight probes for detecting chromosomal rearrangements reported in acute myeloid leukemia and myelodysplastic syndromes.
The probes are for use in Cancer Genetics' FISH-based HPV-Associated Cancer Test, which measures genomic changes to help triage cervical cancer patients.
The alliance announced earlier this month merges extensive oncology testing services from NeoGenomics with PPD's global CRO capabilities.
The assay correlates shortened telomere lengths in patients of different ages to potential risks for inherited diseases, such as bone marrow failure syndrome and liver cancer.
Rome-based Resnova will distribute Empire's FISH probes and molecular diagnostic services in Italy.
Angle aims to show that clinicians can determine HER-2 status by subjecting harvested circulating tumor cells to fluorescence in situ hybridization (FISH).