There are countless steps on the road from a revolutionary discovery to a market-ready health innovation. Some of those steps are a little bigger than others.
Alberta-based precision biotechnology company, Syantra Inc. has spent nearly a decade developing a blood test for the early detection of breast cancer. In winter 2020, the Syantra team took one of those big steps towards their goal. They began working with the College of Physicians and Surgeons of Alberta (CPSA) to gain lab accreditation to enable commercial operations.
CPSA accreditation was a critical step for Syantra for a few of reasons. First, it expanded the Quality Management System the company first implemented in 2017 under the ISO standard for medical product manufacturing to include laboratory testing as a service.
“Quality systems form the backbone of what we do as a precision medicine company... so expanding our system to meet CPSA requirements was something we were readily able to do,” says Bob Shepherd, President and Chief Executive Officer at Syantra.
Second, the CPSA accreditation allowed Syantra to begin doing what they had set out to do. In Alberta, any laboratory that performs and reports diagnostic tests to guide patient care needs CPSA accreditation to operate. For Syantra, this accreditation meant they could offer the Syantra DX | Breast Cancer test through their Calgary lab. And in July 2021, they were able to do just that.
“When we heard that we’d been granted provisional accreditation, we were ecstatic. It’s always great to know that hard work was effective and that we could take the next steps right away toward launching our test,” says Shepherd.
But they couldn’t shout it from the rooftops right away. Syantra awaited the official ratification of their accreditation to make the announcement. More than a year after first engaging with CPSA, it happened on October 28, 2021.
“We were thrilled to receive the provisional accreditation in July because it meant we could accelerate and begin to offer tests to the public,” says Shepherd. “And with CPSA ratification, another milestone has been reached on our journey to bring the Syantra DX | Breast Cancer test to women around the world.”
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