DioGenix is expanding the scope of a crucial clinical trial for a multiple sclerosis genetic test that could drastically reduce misdiagnosis of the degenerative disease. President and CEO Larry Tiffany told FierceDiagnostics that $3.2 million in new financing will help bring what has arguably become the largest trial of its kind in MS to completion through 2014.
About $1.5 million in Series B financing helped launch a 150-patient trial for the MSPrecise diagnostic about a year ago. The new funding, from "high-net-wealth individuals" and returning investors such as life sciences fund Nerveda, backs a larger effort that could ultimately enroll 250 patients before the trial is complete, Tiffany said.
"Having access to a larger patient population is advantageous both now and in the future," Tiffany told us.
Additionally, the new funding will help DioGenix build out a core development laboratory at its Gaithersburg, MD, headquarters, something that will eventually become a CLIA-certified facility once the test is available for patients.
Right now, patients suspected of having MS have the option of tests including an MRI of the brain and spinal cord and cerebral spinal fluid tests that can take weeks or longer to complete. Tiffany has said that those assays can lead to misdiagnoses up to 58% of the time in some cases. The difference with MSPrecise is that it analyzes cerebral spinal fluid at the genetic level, allowing for a much more precise diagnosis either way and reducing the number of false positives and false negatives.
With results produced in 8 to 10 days, patients that test positive can begin MS drug treatments more quickly. Earlier intervention is thought to reduce MS attacks and slow progression of the neurodegenerative disease. By reducing false positives, the number of patients who are placed on unneeded MS therapies would go down, a plus that can help save healthcare costs.
A CRO is continuing work on the company's clinical validation trial, with a hope of completing enrollment in early 2014. Tiffany said DioGenix wants to finish the study itself and report the results within the first couple of quarters of next year.
The $3.2 million in funding, dubbed a private financing, is expected to take the company through the end of 2014. By then, Tiffany said, DioGenix will need to raise more money, but expects to have enough data and be close enough to market to fuel that effort. How much will be needed? That depends on a number of factors, including the clinical trial results, and news from CMS about coding and reimbursement of the lab-developed test, Tiffany said.
- read the release