Diagnostic testing has long laid the groundwork for medical decision-making. In-vitro diagnostics inform more than two-thirds of clinical decisions around the globe, including in the U.S. and Canada, where lab test results guide diagnoses, treatment selections and subsequent care pathways.
In the past, physicians mainly ordered tests with the goal of detecting existing diseases and chronic conditions. With the rise of genomics and biomarkers, more diagnostic testing is now being conducted proactively, to identify risks and initiate preventative therapies as early as possible. This marks a shift in the role that testing plays in healthcare, one that mirrors a broader trend across the industry—towards preserving health through disease prevention rather than merely treating sickness after it develops.
In Canada, every province or territory is required to cover medically necessary diagnostic tests and procedures, but determining what’s “medically necessary” is up to the individual provinces.
“Each Canadian province’s schedule of covered diagnostics is different,” says Rob Dottori, Director of Private Payer and Virtual Markets at LifeLabs. “Companion diagnostics for therapies that haven’t yet been approved by Health Canada aren’t usually covered. These may be drugs that have already been successfully commercialized in other countries, but pharmaceutical companies may want to learn more about whether they could help Canadian patients. Another example is biomarker testing that can indicate which patients are most likely to develop a disease in the future.”
To enhance access to therapies and improve patient outcomes, pharmaceutical companies are initiating sponsored testing programs. Such programs can accelerate diagnostic pathways by removing financial barriers that inhibit access to testing. They can also give sponsors vital insights into the Canadian drug market, helping them identify patients with unmet medical needs as well as providers who could benefit from physician education.
Let’s take a closer look at some disease areas where proactive testing has great potential to improve outcomes and transform care.
Chronic kidney disease
Diabetes is the single most common cause of chronic kidney disease (CKD) and renal failure in Canada. Approximately one-third of Canadian adults with diabetes also have CKD, which can bring fatigue, physical and cognitive disabilities, and, eventually, the need for dialysis or an organ transplant. Much of this suffering can be alleviated by administering preventative treatments that delay CKD progression.
Diabetes Canada recently published new clinical practice guidelines for proactively identifying CKD risks in people living with diabetes. The recommendation is that all diabetes patients receive annual CKD screening using an estimated globulin filtration rate (eGFR) blood test as well as an albumin-creatine ratio (ACR) urine test. The regular routine tests for kidney disease are covered by the Canadian government, but the advanced risk identification tool that predicts CKD progression is not.
“Sponsored testing can enable broader access to predictive assays that can tell which patients are at greatest risk of developing chronic kidney disease,” explains Nader Boctor, M.D., Director of Product at LifeLabs. “You can start these patients on a set of medications that can delay the progression of the disease before they even develop symptoms. This can put off the need for dialysis for ten years or more. It’s a huge improvement in quality of life.”
Metabolic dysfunction-associated steatotic liver disease (MASLD)
Also associated with diabetes, MASLD—formerly known as nonalcoholic fatty liver disease (NAFLD)—is generally without symptoms until the disease has progressed to a later and more serious stage. Non-invasive tests such as Fibrosis-4 (FIB-4) and Enhanced Liver Fibrosis (ELF) screening can forecast which patients will develop MASLD or progress to advanced fibrosis without the need for a biopsy.
“It’s impossible to detect early-stage MASLD without testing,” says Boctor. “It’s a silent condition. If MASLD is caught early enough and treated successfully, the liver damage can be reversed. But newer treatments such as GLP-1s show enormous promise for reducing liver fat and slowing—or entirely preventing—progression to cirrhosis.”
Alzheimer’s disease
The earlier that Alzheimer’s disease is diagnosed, the sooner patients can start on the disease-modifying therapies that can slow or reduce their cognitive and functional decline. Patients may also be eligible to participate in a wider variety of clinical trials and may be able to make lifestyle changes that help preserve cognitive function. And they’ll have more time to make financial and care plans.
Emerging blood and biomarker tests, including APO-E genotyping and p-tau-217 assays, have been shown to accurately predict future neurodegeneration in patients presenting with mild cognitive impairment (MCI) and early-stage Alzheimer’s.
By partnering with a diagnostic testing laboratory, pharmaceutical companies can expand access to tests that can help patients live longer, healthier lives. At the same time, they can gain insights into disease prevalence and trends, and can leverage these insights to develop targeted commercialization strategies to increase market adoption of their treatments.
“Sponsored testing can help patients have better outcomes,” says Boctor. “But physician education is also needed. Recognizing at-risk patients before they develop symptoms requires healthcare providers to adopt a whole new way of thinking about what diagnostic testing can achieve.”
Want to learn more about how LifeLabs is improving the treatment journey for patients and helping drug developers accelerate access and adoption? Visit us online.
