Table 2.
Use of FDA-Approved versus Laboratory-Developed Diagnostic Tests Across Patient Treatment Settings and Insurance Types
| Patient treatment setting |
Patient insurance type |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Test used, by molecular abnormalities | Total sample, N (%) | Academic center, N (%) | Community-based center, N (%) | Private clinic, N (%) | Medicare only, N (%) | Private, N (%) | Medicaid only, N (%) | Medicare + Medicaid, N (%) | Other, N (%) |
| EGFR | |||||||||
| FDA-approved | 273 (73) | 96 (65) | 47 (69) | 130 (82) | 103 (75) | 103 (73) | 36 (72) | 5 (56) | 26 (72) |
| Laboratory-developed | 101 (27) | 51 (35) | 21 (31) | 29 (18) | 35 (25) | 38 (27) | 14 (28) | 4 (44) | 10 (28) |
| ALK | |||||||||
| FDA-approved | 219 (70) | 78 (56) | 40 (71) | 101 (86) | 85 (71) | 85 (71) | 28 (70) | 4 (50) | 17 (61) |
| Laboratory-developed | 95 (30) | 65 (44) | 16 (29) | 17 (14) | 34 (29) | 34 (29) | 12 (30) | 4 (50) | 11 (39) |
| BRAF V600E | |||||||||
| FDA-approved | 75 (58) | 22 (44) | 15 (48) | 38 (79) | 24 (57) | 32 (59) | 16 (73) | 1 (33) | 2 (25) |
| Laboratory-developed | 54 (42) | 28 (56) | 16 (52) | 10 (21) | 18 (43) | 22 (41) | 6 (27) | 2 (67) | 6 (75) |
| ROS1 | |||||||||
| FDA-approved | 62 (38) | 24 (41) | 6 (18) | 32 (44) | 20 (35) | 27 (42) | 11 (42) | 1 (20) | 3 (30) |
| Laboratory-developed | 101 (62) | 34 (59) | 27 (82) | 40 (56) | 37 (65) | 38 (58) | 15 (58) | 4 (80) | 7 (70) |
NOTE: This table only includes information about patients for whom we were able to identify whether their diagnostic test was FDA-approved or laboratory-developed. Differences in the use of FDA-approved tests for EGFR mutations between the academic (65.3%) and private (81.8%) practice settings were significant (P <.05), based on chi-square tests. Differences in the use of FDA-approved tests for ALK rearrangements between the academic (55.7%) and private (85.6%) practice settings were significant (P <.05), based on chi-square tests.
FDA indicates US Food and Drug Administration.