SG ORAL TEST
Test for the early diagnosis of oral cancer.
Studium Genetics oral test for early detection of oral cancer
- Description
- information
- benefits
- studies
- legal information
The SG oral kit includes:
- 5 sterile brushes with break-off tips, individually packaged
- 5 sample collection vials with barcodes containing 400 µL of preservation solution
- 5 duplicate labels with an identifier for patient registration and anonymization
- 1 user manual
Early diagnosis and prognosis of recurrence:
Oral swab samples are processed by a centralized next-generation sequencing laboratory to determine the risk of oral squamous cell carcinoma. The test is based on measuring DNA methylation in a specific set of 13 genes.
This method also has prognostic value for predicting recurrence: a buccal swab is taken from patients who have undergone surgery, on the regenerated mucosa covering the area where the OSCC was surgically excised, during routine follow-up every 3 months. The test has been clinically validated, and the data have been published in several peer-reviewed international journals (see www.studiumgenetics.com for references).
Identification of lesion type :
- Invasive carcinoma
- Low- or high-grade dysplasia
- Oral lichen planus
- Benign reactive lesion
- Studium Genetics is a company specializing in precision medicine through advanced genomic and epigenetic testing, which has significantly improved diagnostic accuracy and prognostic prediction for cancer, neurological disorders, and complex age-related diseases.
- Non-invasive test : cells collected from the buccal mucosa using a swab
- SG-OCRA™ innovation : epigenetic analysis using next-generation sequencing in a certified laboratory
- Simplified logistics: samples stored at room temperature and shipped using prepaid envelopes
- Test sensitivity: 94.9%
- Test specificity: 96.7%
- Gabusi A, Gissi DB, Querzoli G, Sangiovanni A, Rossi R, Lucchi E, Tarsitano A, Montebugnoli L, Foschini MP, Morandi L. DNA methylation analysis from oral brushing reveals a field cancerization effect in proliferative verrucous leukoplakia. Pathologica. 2024 Dec ; 116(6): 368-378.
- Rossi R, Gissi DB, Gabusi A, Fabbri VP, Balbi T, Tarsitano A, Morandi L. A 13-Gene DNA Methylation Analysis Using Oral Brushing. Specimens as an Indicator of Oral Cancer Risk : A Descriptive Case Report. Diagnostics (Basel). 2022 Jan 23 ; 12(2): 284.
- Gissi DB, Morandi L, Gabusi A, Tarsitano A, Marchetti C, Cura F, Palmieri A, Montebugnoli L, Asioli S, Foschini MP, Scapoli L. A Noninvasive Test for MicroRNA Expression in Oral Squamous Cel Carcinoma. Int J Mol Sci. 2018 Jun 16 ; 19(6): 1789.
- Morandi L, Gissi D, Tarsitano A, Asioli S, Monti V, Del Corso G, Marchetti C, Montebugnoli L, Foschini MP. DNA methylation analysis by bisulfite next-generation sequencing for early detection of oral squamous cell carcinoma and high-grade squamous intraepithelial lesion from oral brushing. J Craniomaxillofac Surg. 2015 Oct ; 43(8): 1494-500.
Description
The SG oral kit includes:
- 5 sterile brushes with break-off tips, individually packaged
- 5 sample collection vials with barcodes containing 400 µL of preservation solution
- 5 duplicate labels with an identifier for patient registration and anonymization
- 1 user manual
Early diagnosis and prognosis of recurrence:
Oral swab samples are processed by a centralized next-generation sequencing laboratory to determine the risk of oral squamous cell carcinoma. The test is based on measuring DNA methylation in a specific set of 13 genes.
This method also has prognostic value for predicting recurrence: a buccal swab is taken from patients who have undergone surgery, on the regenerated mucosa covering the area where the OSCC was surgically excised, during routine follow-up every 3 months. The test has been clinically validated, and the data have been published in several peer-reviewed international journals (see www.studiumgenetics.com for references).
Identification of lesion type :
- Invasive carcinoma
- Low- or high-grade dysplasia
- Oral lichen planus
- Benign reactive lesion
Additional information
| Information | <ul>Studium Genetics is a company specializing in precision medicine through advanced genomic and epigenetic testing, which has significantly improved diagnostic accuracy and prognostic prediction for cancer, neurological disorders, and complex age-related diseases.</ul> |
|---|---|
| Benefits | <ul><li>Non-invasive test : cells collected from the buccal mucosa using a swab</li> |
| Studies | <ol start="1"> <li>Rossi R, Gissi DB, Gabusi A, Fabbri VP, Balbi T, Tarsitano A, Morandi L. A 13-Gene DNA Methylation Analysis Using Oral Brushing. Specimens as an Indicator of Oral Cancer Risk : A Descriptive Case Report. Diagnostics (Basel). 2022 Jan 23 ; 12(2): 284.</li> <li>Gissi DB, Morandi L, Gabusi A, Tarsitano A, Marchetti C, Cura F, Palmieri A, Montebugnoli L, Asioli S, Foschini MP, Scapoli L. A Noninvasive Test for MicroRNA Expression in Oral Squamous Cel Carcinoma. Int J Mol Sci. 2018 Jun 16 ; 19(6): 1789.</li> <li>Morandi L, Gissi D, Tarsitano A, Asioli S, Monti V, Del Corso G, Marchetti C, Montebugnoli L, Foschini MP. DNA methylation analysis by bisulfite next-generation sequencing for early detection of oral squamous cell carcinoma and high-grade squamous intraepithelial lesion from oral brushing. J Craniomaxillofac Surg. 2015 Oct ; 43(8): 1494-500.</li> |
| Legal information | SG-OCRA™ Oral Swab Kit |
| Fabricant | <img src="https://gamida.fr/wp-content/uploads/2026/05/logo-Studium-noir.png"> |
| Traduction_FR | 10185 |
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