Circulating tumor cell assay to non-invasively evaluate PD-L1 and other therapeutic targets in multiple cancers.
Journal
PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081
Informations de publication
Date de publication:
2022
2022
Historique:
received:
29
01
2022
accepted:
04
06
2022
entrez:
17
6
2022
pubmed:
18
6
2022
medline:
22
6
2022
Statut:
epublish
Résumé
Biomarker directed selection of targeted anti-neoplastic agents such as immune checkpoint inhibitors, small molecule inhibitors and monoclonal antibodies form an important aspect of cancer treatment. Immunohistochemistry (IHC) analysis of the tumor tissue is the method of choice to evaluate the presence of these biomarkers. However, a significant barrier to biomarker testing on tissue is the availability of an adequate amount of tissue and need for repetitive sampling due to tumor evolution. Also, tumor tissue testing is not immune to inter- and intra-tumor heterogeneity. We describe the analytical and clinical validation of a Circulating Tumor Cell (CTC) assay to accurately assess the presence of PD-L1 22C3 and PD-L1 28.8, ER, PR and HER2, from patients with solid tumors to guide the choice of suitable targeted therapies. Analytically, the test has high sensitivity, specificity, linearity and precision. Based on a blinded case control study, the clinical sensitivity and specificity for PD-L1 (22C3 and 28.8) was determined to be 90% and 100% respectively. The clinical sensitivity and specificity was 83% and 89% for ER; 80% and 94% for PR; 63% and 89% for HER2 (by ICC); and 100% and 92% for HER2 (by FISH), respectively. The performance characteristics of the test support its suitability and adaptability for routine clinical use.
Identifiants
pubmed: 35714131
doi: 10.1371/journal.pone.0270139
pii: PONE-D-22-02874
pmc: PMC9205490
doi:
Substances chimiques
B7-H1 Antigen
0
Biomarkers, Tumor
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0270139Déclaration de conflit d'intérêts
The author – Raymond Page declares no competing interests. The authors – Darshana Patil, Dadasaheb Akolkar, Sudha S Murthy, Kiran Bendale, Revati Patil, Pradeep Fulmali, Pooja Fulmali, Archana Adhav, Sneha Puranik, Sachin Apurwa, Vineet Datta, Chirantan Bose, Stefan Schuster, Jinumary John and Ajay Srinivasan are employees of the Study Sponsor. The author – Rajan Datar is the founder of the Study Sponsor. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
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