Biocare Medical is proud to announce the availability of a new highly specific p40 mouse monoclonal antibody (IVD). Mouse monoclonal anti-p40 [BC28] demonstrated similar sensitivity and specificity as the rabbit polyclonal p40, staining 97% (65/67) of cases of lung squamous cell carcinoma (SqCC) and 0% (0/71) cases of lung adenocarcinoma (ADC), in an in-house study. In addition, the mouse monoclonal antibody has significantly less background and does not stain macrophages. The mouse monoclonal anti-p40 [BC28] was developed wholly by Biocare Medical through an intensive effort to identify an anti-p40 clone with superior staining performance in immunohistochemistry (IHC). p40 (M) [BC28] is available exclusively from Biocare Medical and its worldwide network of distributors (Patent pending).

p40 may have applications in cases where p63 has traditionally been used as an IHC marker. In recent studies, staining with rabbit polyclonal p40 was equivalent to p63 [4A4] in sensitivity for lung squamous cell carcinoma (SqCC), but p40 exhibited markedly superior specificity due to staining in fewer cases of lung adenocarcinoma (ADC) compared to p63 (1-3). p40 has also been reported in combination with TTF 1 in a method to improve specificity for SqCC vs. ADC, while preserving limited tissue specimens (3,4).

“Biocare Medical continually strives to improve the diagnostic tools available to pathologists. With the introduction of the p40 monoclonal antibody, we hope to further enhance confidence in a patient’s diagnosis; especially in cases of discriminating lung SqCC vs. ADC, where a correct diagnosis is critical for therapeutic direction. The p40 monoclonal antibody shows equivalent sensitivity, but superior specificity compared to p63 and should become the standard IHC marker for lung cancer” says Dr. David Tacha, Chief Scientific Officer of Biocare Medical.

About p40 (M)
The mouse monoclonal antibody p40 [BC28] recognizes an epitope unique to the p40 protein and may have applications in cases where p63 has traditionally been used. To date, p63 [4A4] has been a frequently used marker for lung squamous cell carcinoma (SqCC), as well as for bladder, breast, prostate, and head and neck cancers. p63 [4A4] recognizes both the p63 and p40 proteins. As a result, p63 has proven to be a sensitive marker for lung SqCC; however it suffers from specificity limitations due to reactivity in a subset of lung adenocarcinomas (ADC). In contrast, p40 is selectively expressed in lung SqCC, offering an opportunity for improved specificity (1-3). Changes in expression of p40 have been implicated in other neoplastic tissues, including bladder, prostate, breast, and head and neck cancers. p40 (M) [BC28] was found to be a sensitive marker in each of these tissues. Studies have strongly supported the routine use of p40 as an alternative for p63 (1, 2).

(1) Bishop JA, et al. Mod Pathol. 2012 Mar;25(3):405-15.
(2) Nonaka D. Am J Surg Pathol. 2012 Jun;36(6):895-9.
(3) Pelosi G, et al. J Thorac Oncol. 2012 Feb;7(2):281-90.
(4) Brown AF, et al. Arch Pathol Lab Med. 2013 Jan 4.

About Biocare Medical
Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation, and the full range of reagents for IHC and ISH lab testing. Biocare Medical is the market leader in simultaneous Multiplex IHC and antibody development, which aids in the assessment of clinical cases and accelerates turnaround time. The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets using tissue immunostaining and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in Concord, California, and has a global distribution network. For more information, please visit

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