Today, point-of-care (POC) devices are the go-to for people who want to monitor their health remotely and obtain faster results. Rather than waiting weeks for test results, individuals can use POC devices for instances such as diabetes, pregnancy, and other health conditions.
With that in mind, Manas Gartia, LSU Mechanical Engineering assistant professor, went to work at creating a POC that could detect a breast cancer gene mutation.
“Breast cancer is the second most common cancer in women in the United States,” said Gartia. “In 2015, 41,523 women died of breast cancer in the U.S., with 3,523 of those in Louisiana. We believe that early detection saves lives. That’s why genetic testing is so popular. People want to catch it [cancer] before it’s found in a mammogram.”
Now, Gartia and his team have created an accessible way for both men and women to test for the BReast CAncer gene one, known as BRCA1. If the test shows a positive, that means there’s a mutation in the BRCA1 gene, and indicates a much higher risk of developing breast or ovarian cancer in women and pancreatic cancer in men.
According to the Maurer Foundation, about 60 percent of women who inherit the BRCA1 gene mutation develop breast cancer, however, not everyone who has the mutation will develop breast cancer and not all breast cancer is a consequence of the mutation.
In response, Gartia’s team created FluoroZen, a home test kit that could save individuals thousands of dollars and prevent nerve-wracking wait time. The DNA microarray analysis, using a smartphone and portable fluorescence microarray-based imaging, provides results in 20 minutes.
Overall, creating the device consisted of three parts: assembling the FluroroZen device, understanding paper microfluidics, and trying to conduct hybridization.
“First, we started with assembling the device, selection, and arrangement of the optical parts, and assessment of the final setup with different food color dyes, colored texts, and the limit of detection,” said Gartia. “The second challenge was understanding the fluid flow in paper microfluidics. Third, we used online tools to choose our gene of interest and find its complementary sequences. We also created mismatched and non-complementary gene sequences to test for hybridization.”
The FluoroZen works by analyzing either saliva or blood DNA that is put on nitrocellulose (NC) paper, which is then set on a glass slide holder. The device detects fluorescent oligonucleotide spots on the paper using two light spectrum filters. One light excites the fluorescent dye while the other captures the emission spectrum. Spots with higher intensity will be brighter; this is an indicator of the presence of a mutated BRCA1 gene. The handy smartphone, which is attached to the POC device, then projects the results onto the device’s screen after processing the spots. A smartphone app will be available for download in order to access the results, and a simple “yes” or “no” will then appear on the smartphone.
“The rapid development of smartphone technology with increasing computing power, high-resolution cameras, GPS capabilities, and internet connectivity has enabled a smartphone-based POC testing [POCT] platform suitable for field deployment,” Gartia said.
Gartia hopes by making the test accessible and cheap, FluoroZen can reach a diverse section of the world that doesn’t always have access to doctors to effectively battle cancer.
“According to 2015 research data, there are 1.7 million women in 106 low-access counties [LAC] in the U.S. who must travel more than 150 miles to see a gynecologic oncologist,” said Gartia. “In 1,125 LACs, 14.8 million women can’t find one within a 50-mile radius. In Louisiana, there are only eight gynecologic oncologists available to 669,705 women in LACs, which makes up 44 percent of the state.”
Gartia said it should cost $50 or less to run a test, but this isn’t guaranteed since doctors and hospitals could raise the price.
“Doctors can charge more, but generally, all the costs are covered by insurance,” he said. “Most of the cost during our research is due to reagents and purification and extraction of DNA from blood or saliva. The cost of the microfluidic device is less than $5 and less than $1 if mass produced.”
Although finding the BRCA1 mutation is Gartia’s main focus, he did say this type of testing could be used as a similar basis for testing other applications.
“Utilizing paper microfluidics for biological assays, along with the smartphone readout setup opens up the possibility of transferring various clinical, as well as environmental, tests to POCT,” said Gartia. “Dr. Melvin [LSU Chemical Engineering Professor Adam Melvin] is interested in finding neurotoxins and hepatotoxins, such as microcystin and cyanopeptolin, due to harmful golden algal blooms found in Lake Pontchartrain. If we can attach that toxin to a fluorescent dye, then we can detect whether that particular toxin is in your water sample.”
Gartia hopes someday soon his device will be accessible and available to the public, with optimism that FluoroZen can promote early detection. Although doctor appointments, testing, and diagnostics come with many associated costs, Gartia wants this device to be a glimmer of hope for a cheaper alternative in the healthcare sector.
“In healthcare, we always talk about ‘better,’ not ‘cheaper,’” said Gartia. “In order to reduce the cost of healthcare, we really need to invest on better and cheaper alternatives. Potentially, this device/method is a small step in that direction.”