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TEST:
NeXT Dx™ Test

Company:
Personalis
Type:
Laboratory Developed Test
Related tests:
Evidence

News

10ms
Personalis Announces Medicare Coverage for NeXT Dx Comprehensive Genomic Tumor Profiling Assay (Businesswire)
"Personalis, Inc...today announced it has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries....NeXT Dx analyzes a tumor’s entire exome (DNA) and transcriptome (RNA) to uncover deeper insights into therapy selection, including RNA-based fusions and advanced biomarkers that smaller panels might miss, such as tumor mutational burden (TMB) and microsatellite instability (MSI). In addition, NeXT Dx utilizes paired tumor and non-tumor samples to report more accurate results."
Medicare • Reimbursement
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NeXT Dx™ Test
1year
Analytic validation of NeXT Dx™, a comprehensive genomic profiling assay. (PubMed, Oncotarget)
NeXT Dx demonstrated analytic sensitivities as follows: SNVs (99.4%), indels (98.2%), CNAs (98.0%), and fusions (95.8%). The overall analytic specificity was >99.0%.
Journal • Tumor mutational burden
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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NeXT Dx™ Test
almost2years
Reimbursement
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NeXT Dx™ Test
over2years
Reimbursement
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NeXT Dx™ Test
3years
Personalis announces issuance of US Patents related to the exome-wide NeXT Liquid Biopsy platform (Personalis Press Release)
"Personalis, Inc...announced the issuance of two key US Patents related to its high-performance, exome-wide liquid biopsy platform, NeXT Liquid Biopsy...The first patent, US Patent No. 11,142,802, entitled 'Methods for Using Mosaicism in Nucleic Acids Sampled Distal to Their Origin', issued on October 12, 2021...The second patent, US Patent No. 11,155,867, entitled 'Methods and Systems for Genetic Analysis', issued on October 26, 2021."
Patent
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NeXT Dx™ Test