Squamous cell carcinoma of the head and neck (SCCHN)

PD-L1 IHC 28-8 pharmDx for Autostainer Link 48

IVD

Intended Use:

This is an in vitro diagnostic medical device that tests PD-L1 protein expression in non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, and esophageal carcinoma tissues (FFPE) using immunohistochemical assay.

Companion diagnosis
Non-small cell lung cancer
- Assist in identifying patients screeningwith NSCLC who will receive combination therapy of OPDIVO® (nivolumab) and YERVOY® (ipilimumab) according to the expression of PD-L1 (≥ 1% tumor cell expression)

Esophageal squamous cell carcinoma
- Assist in identifying patients with esophageal squamous cell carcinoma (ESCC) who will receive OPDIVO® (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy or combination therapy of OPDIVO® (nivolumab) and YERVOY® (ipilimumab) according to the expression of PD-L1 (≥ 1% tumor cell expression)

Complementary diagnosis
Non-squamous non-small cell lung cancer
- Assist in estimating enhanced survival according to tumor cell PD-L1 expression levels (≥ 1 % or ≥ 5 % or ≥ 10 %) when OPDIVO® (nivolumab) is prescribed for patients with non-squamous non-small cell lung cancer (nsNSCLC)

Squamous cell carcinoma of the head and neck
- Assist in estimating enhanced survival according to a tumor cell PD-L1 expression level (≥ 1 %) when OPDIVO® (nivolumab) is prescribed for patients with SCCHN

Gastric, GEJ, and esophageal adenocarcinoma
-Assist in estimating PD-L1 expression (CPS ≥ 5 in gastric, GEJ, or esophageal adenocarcinoma may relate with the progression-free survival and enhanced survival when combination therapy of OPDIVO® (nivolumab) and chemotherapy is used.

For In Vitro Diagnostic Use.

PD-L1 IHC 28-8 pharmDx

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Features

PD-L1 IHC 28-8 pharmDx kit
The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides,, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal rabbit antibody to PD-L1 and 50 slides incubated with the corresponding negative control reagent, 100 slides in total).

Featured References

Product Description References: 1. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus Docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med 2015; 10.1056/NEJMoa1507643.
2. Phillips T, Simmons P, Inzunza HD, et al. Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer. Appl Immuno Molec Morph 2015; 23(8):541-9.
3. Ferris RL, Blumenschein G, Fayette J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck, N Engl J Med. 2016: DOI: 10.1056/NEJMoa1602252.
4. Hellmann MD, Paz-Ares L, Caro RB, Zurawski B, Kim SW, Costa EC, Park K, Alexandru A, Lupinacci L, Jimenez EM, Sakai H, Albert I et al. Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer. N Engl J Med 2019; 381:2020-2031.
5. Janjigian Y.Y.; Shitara K.; Moehler, M.; et. al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet 2021, 398 (10294), 27-40.
6. Doki, Y.; Ajani, J.A.; Kato, K.; et al. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med 2022, 386(5), 449-462.