A nonprofit discovery lab in Teton County is developing a new rapid blood test to help diagnose ALS, also known as Lou Gehrig's disease.
The in-the-works test can identify an ALS patient with 97% accuracy, according to the findings recently published by the team at Brain Chemistry Labs in the peer-reviewed journal Molecular Biology.
ALS is a relatively rare neurodegenerative disease with no cure, affecting roughly 30,000 people in the U.S. It’s characterized by a loss of muscle control and can be difficult to accurately diagnose, especially in its early stages. Most people live about 2 to 5 years after their symptoms develop.
Sandra Banack is a senior scientist at Brain Chemistry Labs and has been working on the new rapid blood test for the last few years.
“ Unfortunately, patients have a very long period of time to get a diagnosis, from when they first start getting symptoms until diagnosis. What our test does is it decreases that time,” she said.
Trialing the technology involved analyzing about 800 blood samples from patients with ALS, as well as healthy controls matched for age and gender.
The new test is based on eight different microRNA, short genetic sequences that help cells control protein synthesis, that seem to form a signature fingerprint of the disease. No diagnostic test for ALS is currently available on the commercial market, but Banack said most of the other in-progress tests are focusing on proteins rather than microRNA.
“Our test is a microRNA test, which precedes the proteins that other people are looking at. So its potential for an early diagnosis is really profound,” she said.
Banack estimated that about 12 Wyomingites are diagnosed with ALS each year. She said they often have to travel to Utah or Colorado to receive palliative care at specialized multidisciplinary ALS clinics.
“ I actually know a lot of patients who have moved to places that have ALS centers to get better care. If you have to move, that's a difficult thing as well,” she said.
But an early diagnosis means patients can avoid getting passed from one provider to another, and can instead connect more quickly with a neurologist who specializes in ALS to help better manage the symptoms of the disease.
“ These early diagnostic tests can give a patient that ability to enjoy life, to have their motor skills and motor neuron system intact and give them some really precious time with family and friends,” said Banack.
According to the lab’s experiments, the new test can also help rule out ALS as a diagnosis.
“ Other mimic diseases for ALS have things that can be done to help a patient and you want to get the patient on the right track as early as possible,” said Banack.
The in-the-works test uses the same PCR technology used to identify COVID-19 and influenza, which could help keep the cost down if the test makes it to the commercial market.
Although it’s not available yet, Banack said the team at Brain Chemistry Labs is working on figuring out the fastest way to get the test out of development and into hospitals.
“ What we need to do is validate the test in a certified lab, which is called a CLIA lab, and once the test is certified, then it's available for patients to send in a blood sample and get a result,” she said.
According to Banack, the test could be available within the next six months or the year if all goes well with the validation process.
She said creating this test, and continuing to develop a possible treatment for ALS at the Jackson lab, is part of why she left behind a position as a tenured university professor.
“ I gave that up to come to Brain Chemistry labs, so that we could help people and we could make a real difference,” said Banack. “ If we can get the diagnostic test out, then we can move into our therapy. We can get a therapy for [ALS patients].”