Liyanage (right) and her brother, Asel Liyanage, are working to commercialize a bladder cancer test that can detect the disease within 15 minutes—no lab needed.

When her grandmother died of cancer, Dr. Thakshila Liyanage vowed to give doctors a better weapon to find cancer early. “If early diagnosis was possible, she should have had a much longer life,” says Liyanage. She devoted her studies, and now a business endeavor, to creating a tool that could accurately diagnose cancer at Stage 0. Her startup, called Early is Good, is fine-tuning its technology at the 16 Tech Innovation District—a development that wooed her back to Indiana from the East Coast. The startup is taking aim first at creating a simple urine test for bladder cancer, a disease desperate for better diagnostics.

About 81,000 new cases of bladder cancer occur each year in the U.S., and Liyanage says it’s one of the most expensive cancers to treat, mostly due to its invasive diagnostic method. The current gold standard to detect bladder cancer is a cystoscopy; a cystoscope with a microscope lens is inserted into the urethra, which is the tube that carries urine from the bladder to the outside of the body. Liyanage says a cystoscopy is known for having complications, and because it’s notoriously uncomfortable, patients avoid the procedure. Due to bladder cancer’s high recurrence rate, patients often have to endure repeated cystoscopies.

Most patients don’t undergo a cystoscopy until they’re having symptoms, which means the disease has progressed beyond its earliest stages. Liyanage says if bladder cancer is detected at Stage 0, the five-year survival rate is 96%; that plummets to less than 5% if detected at Stage 4.

And that’s why Early is Good is developing a bladder cancer diagnostic so sensitive, Liyanage says it can detect the cancer at Stage 0. The test, called BCDx, detects biomarkers that can be found in urine—no lab needed.

“Cancer is the mutation of one or several genes. A biomarker is a small molecule that brings the information in order to make this mutation,” says Liyanage. “So if you can capture this biomarker, you can get more information about what’s really going on inside your body.”

Early is Good is currently validating its test, which the startup says examines 11 biomarkers in a urine sample. While other biomarker-based urine tests are commercially available, Liyanage says they only involve one or two biomarkers.

“The biggest challenge with biomarker testing today is accuracy. If you depend on one or two biomarkers, the accuracy of diagnosis is very low,” says Liyanage. “That’s why we wanted to increase the number of biomarkers to 11 for the most accurate diagnosis of bladder cancer.”

Very recently, even Liyanage had a traumatic experience of enduring a false positive on a biomarker cancer screening. A test involving six biomarkers led multiple oncologists to tell her she very likely had ovarian cancer, so she underwent surgery only to discover she didn’t have cancer.

“A false positive is not right for the patient, because the amount of stress isn’t good for anyone; it wasn’t just me, my entire family was down,” says Liyanage. “But today, when I think about the emotional distress and uncertainty I had to go through, they were worth it, because I better understand the importance of the work I’m doing.”

Liyanage says the biomarker screenings currently on the market also require high-tech lab analysis and a trained professional to complete the purification and amplification steps. In contrast, she says BCDx can interpret the sample and deliver results using a smartphone app within 15 minutes.

After earning her PhD from Purdue University, Liyanage launched Early is Good in Virginia, where she was pursuing a postdoc. However, she and her co-founder and brother Asel Liyanage—who also graduated from Purdue—couldn’t resist the startup environment at 16 Tech in Indianapolis and returned to the Hoosier state.

“We believe it’s the best decision we made. The Indiana Biosciences Research Institute [headquartered at 16 Tech] is providing a lot of opportunities for scientists like us,” says Liyanage. “We see the long picture in Indiana now through BioCrossroads and IBRI. We never thought that would be possible, and we are very thankful.”  

To obtain patient urine samples to validate the test, the startup is collaborating with the Indiana Biobank through the Indiana CTSI, and later added a partnership with the tissue bank at the IU Simon Comprehensive Cancer Center. The next major goal on the horizon is to submit BCDx to the U.S. Food and Drug Administration for approval as a diagnostic test. Liyanage believes BCDx could also be adapted for other urological cancers, and even beyond.

“We’re now seeing the bigger picture of the massive impact we can have with Early is Good in the cancer arena,” says Liyanage. “I know the pain of losing a loved one to cancer, and I wanted to find a way to contribute. Diagnostics play an important role, because if you diagnose early, you have more options to treat. I believe the biomarker [method] will provide the key change for the early diagnosis of cancer and help to beat this deadly disease.” 

Liyanage says BioCrossroads’ focus on education is especially appealing, as Early is Good looks to the future at 16 Tech.