After the U.K.’s recent approval of two non-invasive diagnostic endometriosis tests, the company behind one of those tests says it is “actively engaging with potential local partners with a view to making this non-invasive diagnostic solution accessible to Canadian patients.”
A spokesperson with biotechnical company Ziwig, which produced the endometriosis spit test Endotest, told Global News that although “our salivary diagnostic test is not yet commercially available in Canada,” the company is “hopeful that these discussions will progress over the coming months.”
The U.K. gave the green light to the Endotest and EndoSure tests on July 7, which health officials there said help rapidly reduce the time it takes for women to be told whether they have the condition.
EndoSure did not respond when asked whether it is trying to bring its test to Canada.
The condition affects at least one in 10 women in Canada, with almost two million Canadians estimated to have endometriosis.
Endometriosis symptoms include chronic pelvic pain, painful periods, pain during or after sex, infertility or difficulty conceiving and gastrointestinal symptoms such as bloating, constipation or diarrhea that can be heightened during menstruation, according to Endometriosis Canada.
Not everyone experiences the same symptoms, with the severity of symptoms not always correlating with the extent of the disease.
Health Canada told Global News it has not approved or regulated these tests in Canada, with provinces and territories being “responsible for the delivery, administration, and oversight of health care services, including testing services.”
If EndoSure and Endotest were to be approved by Health Canada, health officials in Saskatchewan and the Northwest Territories stated to Global News their interest in bringing the tests to their health-care systems.
Saskatchewan’s ministry of health said to Global News the province “will consider coverage of tests that are approved by Health Canada.”
The Northwest Territories’ government also said to Global News it is “interested in innovations that have the potential to improve the diagnosis and care of residents living with conditions such as endometriosis.”
British Columbia’s health ministry said that it is “aware of these new testing technologies” and “supports introducing new technologies provided they are safe, cost-effective, and can demonstrate meaningful clinical benefits.”
Lily Barnes, spokesperson for Ontario’s minister of health, told Global News that the province “continuously monitors emerging evidence, innovations, and best practices that may improve patient care and health outcomes,” but did not comment on EndoSure or Endotest.
Quebec’s provincial health ministry said that the tests are not approved by Health Canada for use in endometriosis diagnoses and are not available in Quebec.
A spokesperson with Yukon’s health ministry said that “Yukon Hospitals has no plans to bring EndoSure or Endotest into our laboratory program.”
A spokesperson with Alberta’s health ministry also said “EndoSure and Endotest have not been approved for use in Canada and are therefore not currently available in Alberta,” adding that the province “routinely reviews emerging diagnostic tests to ensure they are supported by evidence and meet patient and healthcare system needs.”
Nunavut’s health department said it is awareness of the tests but did not say whether the territory would offer them if approved by Health Canada.
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All other provinces and territories did not respond to comment in time for publication.
The EndoSure test “detects endometriosis by measuring electrical signals in the gut using sensor pads on the abdomen,” according to the NHS Foundation Trust.
Women are required to fast for six to eight hours beforehand, and during the test are asked to drink water until full, helping the device record gut activity accurately.
Results are available as soon as the test is complete, which is estimated to take about 30 minutes, according to the company’s website.
Dr. Paul Yong, Canada research chair in Endometriosis and Pelvic Pain at the University of British Columbia, said that the EndoSure is “based on detecting motility of the bowel” and “movement of the bowel.”
“The idea is that there’s a change in that because of inflammation in the abdomen related to endometriosis,” he said.
The company’s website also states that “the test is a game changer in how physicians diagnose endometriosis, and can be used during the initial encounter for patients presenting with pelvic or menstrual pain and unprecedented opportunity for effective post-treatment monitoring regardless of endo treatment type.”
With Endotest, the NHS Foundation Trust says women are supposed to provide a saliva sample, which is sent off to a lab to check for tiny biological markers called microRNAs, which indicates the presence of endometriosis.
Both tests have been approved to be implemented for three years in the U.K. in order to evaluate their performance.
“Early economic modelling suggests that both technologies could be cost effective,” the NHS has said.
Yong also stated that both tests are “a huge step” since “the goal is to reduce the delay to diagnosis.”
“We’ve wanted a non-invasive, non-surgical test for endometriosis for many years. So, this is really a big deal.”
The tests are characterized as “biomarkers” that look at “essentially an indirect sign of endometriosis,” according to Dr. Mathew Leonardi, academic gynecologic surgeon and ultrasound specialist at McMaster University Medical Center.
“A saliva test looks at molecules, things like microRNA, and the EndoSure test looks at the activity of the gastrointestinal system. Neither of them are seeing directly endometriosis but are seeing signs of endometriosis through the effect on the saliva or the effect of the gastrointestinal system.”
Endometriosis Canada’s president Violeta Kondovski also said that EndoSure “would be really helpful for teenagers to help get them diagnosed sooner so that they’re not missing school.”
“Sometimes they drop out of sports, and it affects them mentally and socially. So, this would help a lot to get them treatment sooner so we could know if they have endometriosis or not and then to help them so they’re not waiting so long to get the right doctor to help that,” she said.
“It would be so much faster.”
Lots of research relating to endometriosis detection has come out of the U.K. in recent months, with a study conducted by the University of Edinburgh uncovering that endometriosis could possibly be diagnosed via a blood test for hormone differences.
An Oxford University study released on June 1 also shed light on a potential non-invasive endometriosis scan that could help give women an earlier explanation for their symptoms.
Even as more awareness to endometriosis diagnoses continues to in Canada, taking the time to listen to patients’ symptoms and concerns remains imperative.
“If you truly listen to a patient, you listen to their experiences, usually things like period pain, pain with intercourse, pain outside of their menstrual cycle, fertility-related issues, if you simply listen to the patient and you ask the person in question, most times you can achieve the diagnosis by talking alone,” said Leonardi.
Between speaking with a health care professional regarding symptoms and getting an official endometriosis diagnosis, it can take an average of five years, and sometimes much longer in Canada.
“It’s pretty brutal right now for patients,” said Kondovski.
Dr. Nicholas Leyland, president of the Society of Obstetricians and Gynaecologists of Canada, said that what is delaying Canadian diagnoses in endometriosis is patients feedback not being listened to by health care specialists.
“Primary care providers, pediatricians, family doctors, and even many gynecologists. They need to understand to listen and take the symptoms seriously from these patients and intervene where appropriate to improve their quality of life.
“Diagnosis is not about a test. It’s actually about respecting the symptoms that people are presenting with and determining the management based on what we have now to begin to help them with their pain or their infertility which are the two major symptoms that women present with endometriosis.”
Leonardi also said that “it’s true that patients have experienced years and years of medical gaslighting, invalidation, doctors dismissing their symptoms.
“This is just a normal thing for a woman to go through.”
