Diagnostic Pipeline
| Company | Preclinical | CLIA | 510K | PMA | Product on Market | Condition/Market |
|---|---|---|---|---|---|---|
| Arctic DX | Macula Risk | Macular Degeneration | ||||
| Armune | Apifiny | Tumor Specific Non-PSA Blood Test for Prostate Cancer | ||||
| Athena Diagnostics | Atlastin (SPG3A) DNA Sequencing Test (#531), Complete Hereditary Spastic Paraplegia Evaluation (#650), Autosomal Dominant HSP Evaluation (#651) | Autosomal Dominant Hereditary Spastic Paraplegia | ||||
| Athena Diagnostics | NIPA1 (SPG6) DNA Sequencing Test (#532), Complete Hereditary Spastic Paraplegia Evaluation (#650), Autosomal Dominant HSP Evaluation (#651) | |||||
| Athena Diagnostics | MR-1 (PNKD) DNA Sequencing Test (#617) | Paroxysmal Nonkinesignenic Dyskinesia | ||||
| Athena Diagnostics | FIG4 DNA Sequencing Test (#224), Partial CMT Evaluation – Recessive Only (#409), Complete CMT Evaluation (#723) | |||||
| Athena Diagnostics | FIG4 DNA Sequencing Test (#224), Complete ALS Evaluation (#704) | Amyotrophic Lateral Sclerosis | ||||
| Becton Dickinson HandyLab | Microfluidic Diagnostic System *BD MAX™ | Nucleic acid and protein diagnostic | ||||
| GenomeDX | PCATS | Decipher™ | Prostate Cancer | |||
| Hologic | TMPRSS2 Gene Fusions | Prostate Cancer | ||||
| Janssen Diagnostics | CTC-Endocrine Index COMETI P2 | Metastatic Breast Cancer | ||||
| Multiple Non Exclusive Licenses | Delta 508 Mutation | Cystic Fibrosis | ||||
| Novelos (Cellectar) | I-131NM404 / I124NM404 | Pet Imaging Agent for Non-Small Cell Lung Cancer and other Solid Tumors | ||||
| Ventana | ERG IVD | Prostate Cancer | ||||
| ViraCor IBT | Reg3alpha, ST2 biomarkers | Graft Versus Host Disease (GVHD) |