San Diego, CA-based Trovagene ($TROV) is taking a different approach to liquid biopsy, using urine to detect and monitor systemic cancers in patients. While the company offers blood- and urine-based molecular tests to measure cancer-related gene mutations from circulating tumor cells, its urine diagnostics provide an extra flexibility for clinicians and patients, Chief Scientific Officer Mark Erlander told FierceDiagnostics.

Trovagene CSO Mark Erlander

Patients are sometimes hundreds of miles away from a hospital and cannot make multiple trips in for testing. And traditional screening methods often call for blood sampling and processing for mutational analyses. Trovagene's urine test is sampled over a week, allowing patients to do the test in the morning and send results to the company's lab for processing.

Trovagene also touts its urine-based diagnostic as more sensitive than traditional biopsies. The company's proprietary technology can screen an ultrashort DNA sequence to provide quantitative data on how mutations respond to therapy over time, providing important information about cancer patients' condition during and after treatment.

"It comes down to the sensitivity of your assays," Erlander said. "In a urine sample, it allows for such a noninvasive and home-sampling situation, you can get a lot more DNA and collect a lot more of a sample. We're leveraging that to have an impact and taking on cell-free more agnostically."

While the company's focus falls primarily in genomic detection for oncology with tests that screen for BRAF and KRAS mutations in circulating tumor DNA and RNA, Trovagene is also developing an HPV screening assay that uses a urine sample to detect the virus in patients who don't have a cervical exam. The company plans to develop the product with a partner outside of the U.S., Erlander said.

Although cell-free DNA screening is primarily used to detect cancer in patients in later stages of the disease, Erlander sees the technology as having multiple applications in the future. Liquid biopsies could be used to monitor patients for recurrence and identify the disease before surgery.

"I think there will be a move in the food chain in cell-free testing to attack these much bigger populations of patients who are on therapy, who have had surgery, and also in screening," Erlander said. "Cell-free has the opportunity to do the entire spectrum. That's why I think it's transformational in cancer patient care."

In 2015, the company plans to roll out tests for different cancer mutations. Trovagene has a multiplexing program underway and recently presented data on its EGFR mutation diagnostics at the European Lung Cancer Conference in Geneva. In February, the company raised $23 million in a follow-on round, giving it a boost as it develops new products for cancer detection.

"Liquid biopsies are transformational. We have a long road to go in cell-free, but the clinical utility is so apparent and undisputed as an alternative to a tissue biopsy. There's not a lot of headwind on that," Erlander said.

For more:
Trovagene raises $23M in follow-on share offering for urine-based cancer diagnostic