Test strips for point of care detection of cervical cancer: Reality in near future.

A prototype of  test strip that could be used for the early detection of cervical cancer.
(Credit: Purdue Research Foundation photo/Curt Slyder)

Researchers at Purdue are developing technology that could enable us to detect cervical cancer with low-cost, easy-to-use, lateral flow test strips that are very similar to home pregnancy tests.

Joseph Irudayaraj, professor of biological engineering in Purdue’s School of Agricultural and Biological Engineering “This field really needs an additional way to test for cervical cancer. A test that can report cervical cancer right away is very instrumental in a lot of low- and middle-income countries where women often get HPV tests and then never come back. In higher-income countries, it’s important that anything beyond HPV tests have the ability to complement those tests.”

The technology developed by Purdue researchers works on the basis of color change of the strip that is visible to naked eye within 15-20 minutes because of reaction with proteins that are specific for cervical cancer.

Using proteomics and bioinformatics, researchers have identified valosin-containing protein (VCP) that are expressed differentially between normal specimens and those with cervical intra-epithelial neoplasia grade 2/3 (CIN2/CIN3+) or worse.

VCP-specific immunohistochemical staining (validated by a point-of-care technology) provided sensitive (93%) and specific (88%) identification of CIN2/CIN3+ and may serve as a critical biomarker for cervical-cancer screening.

The paper was published earlier in April 2016 in Journal of Oncotarget .

Combining proteomics and lateral-flow immunochromatography (LFIC) technology the researchers have formulated a simple point of care test for cervical cancer screening that can be used in low- and middle-income countries (LMICs).

Pap cytology followed by further evaluation using HPV DNA/ colposcopy and biopsy for abnormal cytology test is the current screening test for detecting cervical cancer. This multistep process that depends on recall system is not sustainable in LMICs.

About 84% of cervical cancer cases occur in low- and middle-income countries, where it is still diagnosed at very late stage leading to high morbidity and mortality according to the World Cancer Research Fund International.

Researchers have already documented the proof of concept are working on the early prototype for the technology, and improving sensitivity and specificity.

“We’re working to greatly improve the detection limit of our testing,” said Wen Ren, a Purdue postdoctoral researcher working with Irudayaraj. “That will make it much easier to detect cervical cancer based on a very low amount of markers in smaller samples.”

Additional work is also underway to develop the test for additional samples like cervical lavage specimens, PreservCyt specimens and cervical swabs.

Larger studies are needed for robust clinical validation and commercialization of the test.

The technology could be of use to detect other diseases in future including pathogens of infectious disease.