Imagine having increased muscle weakness for two years before figuring out the cause. That is the shared experience of myasthenia gravis patients. Canadian startup Decipher MedTech is developing a rapid diagnostic kit for the rare disease, aiming to significantly shorten the time for a patient to get the proper treatment.
Founded in August 2021, Decipher is a spinoff from the University of Alberta. CEO Richard Fahlman, a biochemistry professor, started the company with Zaeem Siddiqi, a physician who treats myasthenia gravis patients. The other three founders are Junzhi Yao, Faraz Hussain and Ramanaguru Siva Piragasam.
According to Fahlman, myasthenia gravis is an autoimmune disease damaging the area where one's nerves touch their muscles. Common symptoms include increased weakness, blurred vision and trouble swallowing – similar to those caused by a stroke or other diseases.
Current autoantibody tests for myasthenia gravis require much time and hold low sensitivity and specificity. Fahlman said 50% of those at the early stage of the disease would test negative, while 30% of healthy people would show up positive.
With the tests available now, patients typically experience about two years to be diagnosed with this disease. Fahlman said some patients even waited five years before getting appropriate diagnosis and treatment.
A new rapid test that any clinic can do
To tackle the challenge of testing, Fahlman, Siddiqi and their graduate and post-doc students looked into plenty of samples, finally finding a unique biomarker among the patients. Fahlman said he cannot disclose the biomarker yet because the company is still seeking patent protection in many nations.
He added that the blood test Decipher develops works like the COVID-19 rapid test. It does not require specialized training as the current ones do, so any clinic would be able to do it.
He also said it takes 15 to 30 minutes for the result to show up, depending on how fast the fusion goes. More than 100 patients, including those in the control group, have taken Decipher's rapid test.
"We haven't found a (myasthenia gravis) patient that doesn't have high levels of this biomarker," the CEO said, "that's what got us so excited."
In contrast, the current test has a turnaround of two to three weeks in Alberta, where Decipher is based. Fahlman said an emergency room will not order the test because of the delay. Moreover, only a few labs in North America can do it.
Targeting 2024 for a market launch
Fahlman said Decipher has developed antibodies for the target protein needed for its test. The company has been optimizing a final prototype through a partner in the US before approaching an in vitro diagnostic test.
The CEO said the company aims to enter the clinical trial in 2023. After finishing the trial and receiving approval from Canada's health agency, Decipher will submit the trial data to the US or the European Union. He said the goal is to launch the diagnostic kit in the market in 2024.
According to Fahlman, Decipher received a commercialization grant from the Alberta government and finished the first seed funding round last year.
"We've already had two venture capitalists interested in the next round of seed funding," he said.
Decipher's estimate shows that the value of the testing market in Canada is roughly US$12 million a year. The US and EU hold a market of US$108 million and US$147 million, respectively. Fahlman said the company is also interested in developing the market in Asia and seeking suppliers when starting production.
While Decipher is still in its infancy, it has great ambitions to tackle testing for other autoimmune diseases. Fahlman said the company already has some preliminary data for rheumatoid arthritis, which also have issues with diagnosing. In addition, it plans to develop proper blood tests for diseases such as multiple sclerosis.
