companion diagnostics development

Ambry Genetics is a clinical genomic testing company based in Aliso Viejo, California, and a wholly owned subsidiary of Tempus AI, Inc. For over 25 years it has provided genetic testing solutions in hereditary cancer, cardiology, neurology, and rare and exome disease, and offers pharma services supporting drug development and companion diagnostics.

assay development and validationDroplet Digital PCRexome testingGenetic testinglab automationlong-read NGSmass spectrometrymicrosatellite instability analysisReal-time PCRregulatory submissionsRNA analysisshort-read NGSSNP and chromosomal microarray

Boudicca® DX is a transatlantic precision medicine consulting and CRO firm with business operations legally established in the EU and US (Brentwood, Tennessee, US and Dublin, Ireland, EU). Founded by Dr. Kelly Gordon, it provides regulatory strategy and full-service CRO support for precision medicine tests, medical devices, and targeted therapies across the EU, US, and Rest of World, with 10+ years in business and 169 clients.

AI-assisted regulatory intelligenceclinical biomarker strategyISO 13485IVD developmentLDT developmentQMSR complianceregulatory strategyregulatory submissionsreimbursement and market accessSaMD development

Functional Fluidics is a CLIA-certified biomarker specialty lab focused on red blood cell health, beginning with Sickle Cell Disease. It provides contract research services to pharmaceutical, BioTech and academic research companies, and offers proprietary cell function assays to clinical providers to support drug development and patient care. The company was founded by CEO Patrick Hines, based on research in the Hines Lab at Wayne State University.

biomarker assaysCLIA-certified labclinical study monitoringcontract researchhigh-throughput cell function testing