DioGenix plans to plow ahead with a 150-patient trial for its potentially game-changing multiple sclerosis molecular diagnostic test, armed now with $1.5 million in new Series B financing.
Larry Tiffany, the company's president and CEO, in an interview with FierceMedicalDevices, said he sees his company's MSPrecise diagnostic as a major improvement over existing standards of MS diagnostics care. Right now, patients suspected of having the neurodegenerative disease face a number of diagnostic tests first, including an MRI of the brain and spinal cord and cerebral spinal fluid test. But those lead to misdiagnoses as much as 58% of the time in some cases, he said, noting that neurologists themselves have self-reported misdiagnoses for MS that surpass 36%. But MSPrecise, which analyzes spinal fluid at the genetic level, would drastically reduce false positives.
"Compared to the current standard of care, which has been in place since the late 1960s, next-generation sequencing looks at specific DNA changes that occur in the immune system as these neurological events start to occur," Tiffany told us.
And that added element would reduce false diagnoses and the number of patients inappropriately put on MS therapies. In addition, patients diagnosed with false negatives would also decline. Both trends would not only reduce unnecessary healthcare costs (a major issue in the post-healthcare-reform world) but also help pair patients with MS drugs much sooner than they otherwise would. Such a test would be used with MRI imaging, but Tiffany envisions it replacing the spinal fluid analysis because of the extra precision. And it would come up with results in about 8 to 10 days.
"Well established clinical data from clinical studies by [MS drug makers] Teva and Biogen Idec and others [shows] that the earlier you provide MS drugs, the better [patients] are in terms of the number of attacks," Tiffany noted. "It has been shown that the progression of the disease over time is retarded by earlier treatment."
The 5-employee company based in Gaithersburg, MD, outsources much of its finance and regulatory functions, and a CRO is helping with the validation trial itself. (An additional 135 patients have tested the diagnostic before now.) Tiffany said that as soon as the study is complete the company would need between 6 and 9 months to evaluate the results, after which they will start offering the test through a certified CLIA lab. Separately, the company believes "it may be advantageous to us" to also pursue 510(k) approval, which would allow DioGenix to license the test to other groups and distributors.
DioGenix, which spun out of Gene Logic in the late 2000s, previously raised $5.3 million in a Series A, funded by Nerveda, an Angel fund that specializes in neurological diseases. Nerveda also led the new round and provided $2 million in convertible debt that will be added to the $1.5 million B round first tranche.
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