(182e) Rapid Molecular Analysis of Human Tumor Samples in Point-of-Care Settings

One of the biggest cancer challenges in low- and middle-income countries (LMICs) is providing rapid and affordable diagnostics that enable patients to obtain locally available treatments. Unfortunately, in many LMICs, diagnosis often takes an extraordinarily long 6-12 months, largely due to lack of pathologists and limited infrastructure¹. To address these barriers to diagnosis, we developed an integrated diagnostic platform with automated analyses, termed CytoPAN—portable fluorescence-based image cytometry analyzer—that can be used by non-expert healthcare providers². We integrated three complementary approaches into a new ‘all-in-one’ platform: i) a disposable fluidic cartridge and prepackaged reagent kits for on-site sample processing, ii) a multi-channel image cytometry analyzer, and iii) a custom-designed software package for automated analysis. In our pilot clinical study with 68 prospectively collected patient samples, we validated CytoPAN’s measurements against the gold standard histopathology; the accuracy for cancer detection was 100% (P < 0.0001, unpaired t test), and the accuracy for receptor subtyping was 97% for HER2 and 93% for ER/PR². Unlike the conventional cytopathological diagnoses that requires trained pathologists and large number of cells, CytoPAN performs fast and accurate cancer diagnosis and molecular subtyping in as few as 100 cells within an hour. Based on these results, we envision prospective clinical trials in remote, decentralized locations. The system is also being deployed in extended field trials in Botswana, funded in part by an NIH global health initiative. The methods will be broadly applicable for other highly prevalent cancers affecting minority and underserved populations domestically and abroad. This platform may alter therapeutic paradigms for breast cancer patients globally and enable the appropriate use of chemotherapies and anti-hormones in limited supply.

REFERENCES

1. Nelson AM, et al. J Clin Oncol. 34(1) 20-26 (2016).

2. Min J, et al. Sci Transl Med. (2020, under re-revision)