Biomoda, Inc.

Lung Check Study

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Lung Check: TCPP Sputum Labeling Study

Elizabeth Lenkiewicz, MS
LungCheck, Inc.

Russell W. Duke, PhD.
LungCheck, Inc.

Lung Check completed September, 1998

This was a blinded study of 60 sputum retrospective samples from the Lung Check Sample Bank using the patented TCPP compound. Specifically, the study results indicated that abnormal cells (mild, moderate or severe dysplasia or cancerous) can be detected with the TCPP detection procedure compared with the PAP-staining procedure. If 2-3% of the TCPP-exposed cells were fluorescing, then the sample reliably correlated with at least the mildly dysplastic diagnosis. Fifty out of 50 sputum samples were determined by the standard cytomorphological PAP-staining procedure to be mildly dysplastic to cancerous and were also identified as abnormal by TCPP detection.  Among the ten samples characterized as normal or metaplastic based on the PAP-staining procedure, four samples demonstrated that same morphology using the TCPP method.  Samples diagnosed as normal showed minimal or no TCPP uptake.

TCPP uptake in cells determined to be negative or metaplastic by cytomorphology had characteristic fluorescence intensity and patterns that were recognizable and diagnostic. Based on fluorescence intensity and pattern in TCPP-treated cell samples, cells were categorized with one of 14 possible numbered classifications relating to a morphological description. If cells were class 11 using the TCPP determination and fewer than 2-3% of the cells on the slide were fluorescent above background levels, then that sample was determined to be metaplastic and not dysplastic. The metaplastic cells were easily differentiated from normal cells by their moderate fluorescence with barely visible cell membrane. Of the ten cell samples that were determined to be negative or metaplastic by PAP-staining, six were designated with a class 11 cell description based on TCPP fluorescence.  Of the six TCPP samples with class 11 designation, three also indicated fluorescence from nuclear debris (i.e., either a class 13 or 14) and two also showed class 10 designation (fluorescence from the nucleus only).

Correlation between TCPP Results and Cytomorphological Results