Quality Resource Guide
l
Techniques for Early Cancer Detection 2nd Edition
3
www.metdental.com
TB is currently not cleared by the FDA as a
stand-alone adjunctive screening aid. It is cleared
for marketing as a follow-on case assessment
marking agent for the light-based adjunctive aids
ViziLite
®
TBlue, Bio/Screen
®
, and MicroLux DL™.
The premise is the TB allows for better visual
lesion delineation of an area initially identified via
the companion light-based adjunct.
32,33
It can help
the provider decide which area within a lesion
should be biopsied. The appropriate CDT code
to apply when using TB is D0431, “adjunctive
pre-diagnostic test that aids in the detection
of mucosal abnormalities including premalignant
and malignant lesions, not to include cytology or
biopsy procedures.”
15
Light-based Adjuncts
Light-based
adjuncts
can
be
categorized
into two basic groups (tissue reflectance and
autofluorescence) based on the manner in
which a specific spectrum of light is used to
assess the reflective properties of the tissue.
All devices are cleared for marketing by the
FDA as chairside illumination aids to assist
the practitioner in identifying new or potentially
overlooked PMDs.
34
Some are also marketed to
assist surgeons in defining appropriate surgical
margins for excision.
27,35
The appropriate CDT
code to apply when using a light-based adjunct is
D0431, “adjunctive pre-diagnostic test that aids in
the detection of mucosal abnormalities including
premalignant and malignant lesions, not to include
cytology or biopsy procedures.”
15
The
tissue
reflectance
adjuncts
(ViziLite
®
TBlue, Microlux DL™) utilize a blue-white light
(wavelength of 430 and 580 nm) to analyze the
tissues.
36
For the ViziLite
®
TBlue product, the
light is generated through a reaction between
acetylsalicylic acid and hydrogen peroxide
(chemiluminescence), while the light for the
Microlux DL™ product is produced by a battery
powered light-emitting diode. The protocol for
both regimens entails the use of a 60 second
pre-rinse with a 1% acetic acid solution to
remove the surface glycoprotein layer and cause
cellular dehydration, to improve the exposure
of cellular elements to the blue-white light.
22,36
Table 4 - Molecular-based adjuncts
18
Product
Company
Biomarkers Assessed
OraRisk
®
HPV Complete
Genotype
OralDNALabs
Eden Prairie, MN
51 HPV strains, both low risk and high risk
OraRisk
®
HPV 16/18/HR
OralDNALabs
Eden Prairie, MN
High risk HPV strains 16, 18, 31, 33, 35,
39, 45, 51, 52, 56, 58, 59, 66, 68
SaliMark™ OSCC
PeriRx, LLC
Broomall, PA
DUSP1, SAT, and OAZ1
Table 3 - Light-based Adjuncts
18
Adjunct
Contact
ViziLite
®
TBlue*
Den-Mat Holdings, LLC Lompoc, CA
Microlux DL™*
AdDent, Inc., Danbury, CT
VELscope
®
Vx
§
LED Dental, White Rock, British Columbia, Canada
Sapphire
®
Plus
§
Den-Mat Holdings, LLC Lompoc, CA
Identafi
® ¶
DentalEZ, Malvern, PA
Bio/Screen
®§
AdDent, Inc., Danbury, CT
DOE SE Kit
§
DentLight Inc., Plano, TX
OralID™
§
Forward Science, Houston, TX
ViziLite PRO
§
Den-Mat Holdings, LLC Lompoc, CA
*
Tissue reflectance - average wavelength 490-510 nm
§
Autofluorescence - average wavelength 400-460 nm
¶
Three individual light spectrums: white light, amber light, autofluorescence
Table 2 - Vital Stain-based Adjuncts
18
Adjunct
Contact
Toluidine chloride stain
(component of ViziLite® Plus with TBlue
®
)
Den-Mat Holdings, LLC Lompoc, CA
OraBlu™
AdDent, Inc., Danbury, CT
Table 1 - Cytology-based Adjuncts
17,18
Adjunct
Contact
OralCDx Brush Test
®
CDx Diagnostics, Suffren, NY
CytID™
Forward Science, Houston, TX
OralCyte™
ClearCyte Diagnostics, Seattle, WA