TABLE I.
Summary of FDA-approved nucleic-acid assays and platforms.
| Assay | Platform | Target | Tissue | Application | Ref. |
|---|---|---|---|---|---|
| Veridex | RT-PCR | mRNA | Formalin-fixed, paraffin-embedded tissue | Cancer of unknown primary origin | 37 |
| miRview (Rosetta genomics) | Microarray | miRNA | Formalin-fixed, paraffin-embedded tissue | Cancer of unknown primary origin | 37 |
| Cancer Type ID (Biotheragnostics) | Taqman™-RT-PCR | mRNA | Formalin-fixed, paraffin-embedded tissue | Cancer of unknown primary origin | 37 |
| CupPrint | Microarray | miRNA | Formalin-fixed, paraffin-embedded tissue | Cancer of unknown primary origin | 37 |
| Genesearch (Veridex) | RT-PCR | mRNA | Lymph node tissue | Breast cancer metastasis | 38–40 |
| mi-LUNG (Rosetta genomics) | Microarray | miRNA | Fine needle aspiration; bronchial brushing | Lung cancer type | 41 |
| Reveal (Rosetta genomics) | Microarray | miRNA | Fine needle aspiration | Thyroid cancer stratification | 42 |
| mi-KIDNEY (Rosetta genomics) | Microarray | miRNA | Kidney cancer type | 43 | |
| Prosigna nCounter (Nanostring) | Signal amplification (hybridization) | mRNA | FFPE | Breast cancer recurrence | 44 and 45 |
| Versant (Siemens) | RT- PCR; signal amplification | Viral RNA | Serum | HCV, HIV-1 | 28 |
| RealTime (Abbot), | Real-time RT-PCR | Viral RNA | Serum | HCV, HIV-1 | 26 and 29 |
| Procleix (GenProbe), | Real-time RT-PCR | Viral RNA | Serum | HCV, HIV-1 | 30 |
| Cobbas (Roche) | Real-time RT-PCR | Viral RNA | Serum | HCV,HIV-1 | 26 and 29 |
| Aptima (Hologic) | Isothermal quantitative RT-PCR; Tigris® DTS® and Panther® | Viral RNA, E6/E7 transcripts from high-risk HPV genotypes | Serum, cervical cytology | HCV, HIV-1, HPV | 31 and 32 |
| NucliSENS /NorChip (BioMérieux) | Nucleic acid sequence–based amplification (NASBA) | Viral RNA, E6/E7 mRNA from high risk HPV types | Throat swabs, cerebrospinal fluid (enterovirus); uterine cervical cytology specimens (HPV) | Enterovirus, HPV | 33 and 34 |