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Stage: Phase III
Enrollment goal: 216 participants
Disease: NSCLC
Biomarker: EGFR ex19del and EGFR L858R
No visibility on the genetic testing practices for this biomarker
An alert was activated for profiles analyzed through the SOPHiA DDM™ Platform
Within a span of 4 months, 40+ new potentially eligible profiles were identified
The sponsor and site were promptly notified to facilitate coordinated patient recruitment efforts
| SOPHiA DDM™ HCS v1.1 (RUO) | SOPHiA DDM™ HCS v2.0 (RUO) | SOPHiA DDM™ Dx HCS (CE-IVD) | |
|---|---|---|---|
| Diseases covered | Hereditary Breast and Ovarian Cancer (HBOC), Lynch and various intestinal polyposis syndromes | Breast, ovarian, prostate, abdominal, endocrine & neuroendocrine, nervous system, renal, and skin | Breast and ovarian cancers and colorectal syndromes |
| Diseases covered | 26 + PMS2CL | 82 + PMS2CL | 26 + PMS2CL |
| Target region size | 105 kb | 285 kb | 105 kb |
| Sample type | Blood | Blood | Blood |
| DNA input amount | 200 ng | 50 ng | 200 ng |
| Sequence |
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| Library prep time | 1.5 days | 1.5 days | 2 days |
| Analysis time from FASTQ | 4 hours | 4 hours | < 6 hours |
| Detected variants |
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SOPHiA GENETICS products are for Research Use Only and not for use in diagnostic procedures unless specified otherwise.
SOPHiA DDM™ Dx Hereditary Cancer Solution, SOPHiA DDM™ Dx RNAtarget Oncology Solution and SOPHiA DDM™ Dx Homologous Recombination Deficiency Solution are available as CE-IVD products for In Vitro Diagnostic Use in the European Economic Area (EEA), the United Kingdom and Switzerland. SOPHiA DDM™ Dx Myeloid Solution and SOPHiA DDM™ Dx Solid Tumor Solution are available as CE-IVD products for In Vitro Diagnostic Use in the EEA, the United Kingdom, Switzerland, and Israel. Information about products that may or may not be available in different countries and if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications for use. Please contact us to obtain the appropriate product information for your country of residence.
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