Decoding the Lingo: Precision and Regenerative Treatments
July 21, 2026
At the cutting edge of medicine, the science is evolving fast – and so is the terminology. In this issue, we’re exploring concepts and technologies that have transformed both the scientific and drug-access landscapes: personalized medicine, precision medicine, regenerative medicine, genomics, and biomarkers. Some stakeholders use these words interchangeably, but they mean different things – and the differences matter for every step of the drug access process, from approval to patient access.
If we’re discussing “cutting-edge” approaches, you may wonder… compared to what? Essentially, we’re talking about how medicine deals with the fact that no two patients are exactly alike. In the past, clinical trials took more of a “one size fits all” approach to find the treatment that, on average, worked best across a whole group of patients. Today, using genomic information and other big data methods, the approach has shifted to looking for the right treatment for the right patient at the right time. And that’s improving patient care across many areas of health, from cancer to neurological conditions to rare diseases.
Here are the key terms that define this emerging area:
PERSONALIZED
MEDICINE:
“WHICH THERAPY
IS RIGHT FOR
THIS PATIENT?”
Personalized medicine: the umbrella term for treatment approaches that tailor prevention, diagnosis, or treatment to an individual's biology, lifestyle, and/or environment.1
Precision medicine: a narrower and more recent subset of personalized medicine that uses molecular/biological information (often from genomic testing – more on that later) to match a patient to the therapy most likely to work for them. Most commonly used today in oncology.2
REGENERATIVE MEDICINE:
“CAN WE BUILD A NEW
THERAPY FROM BIOLOGY
ITSELF?”
Regenerative medicine: an approach to treatment that aims to repair, replace, or regrow damaged cells, tissues, or organs. These treatments can include stem cells and other cell-based therapies (including CAR-T), gene therapies, tissue-engineered products (e.g., bioengineered skin), and the scaffolds and biomaterials that go with them.3 This is where the lines can get a bit blurred because some regenerative approaches double as personalized/precision medicine (such as gene therapies intended for people with specific mutations).
Gene therapy: a type of regenerative therapy that aims to replace, suppress, or restore a faulty gene, often with the goal of a one-time, potentially curative intervention.4
Whether they’re personalized, regenerative, cell-based, or all of the above, many of these therapies rely on state-of-the-art testing to match the right patient with the right treatment.
TESTING:
“HOW DO WE MATCH THE
PATIENT WITH THE RIGHT THERAPY?”
Genomics: the study of a person's entire DNA. In personalized medicine, the term covers both germline genomics (inherited DNA, relevant to hereditary cancer risk and pharmacogenomics) and somatic/tumour genomics (mutations that a tumour acquires, relevant to choosing cancer therapy).5
Biomarker testing: any test that measures a biological signal (a gene, protein, or other molecule) to inform diagnosis, prognosis, or treatment choice. Tumour/molecular profiling and comprehensive genomic profiling (CGP) are forms of biomarker testing. Germline testing, hereditary cancer testing, and pharmacogenomic testing are also biomarker testing — just on inherited DNA, not tumour DNA.6
Actionable biomarker: a biomarker test that informs disease management. CGP and other larger-scale genomic tests can generate vast amounts of information, but not all of it helps clinicians make treatment decisions. (For example, medical scientists may not yet understand the significance of some mutations.) An actionable biomarker helps define the path forward, whether for disease prevention (e.g., surgery to reduce breast cancer risk in patients with BRCA1 gene mutations7) or treatment (e.g., targeted anti-HER2 medications in patients with breast cancer that is positive for the HER2 biomarker8).
DEFINING QUESTIONS
Precision medicine: “Which therapy is right for this patient?”
Regenerative medicine: “Can we build a new therapy from biology itself?
Testing: “How do we find the right patients for a treatment?”
BY THE NUMBERS
$2.5 million: Initial investment that the Québec government is making to launch the Québec Genomic Medicine Policy, the first of its kind in Canada. Their goal is to provide “healthcare that is more precise, more personalized, and better adapted to each person.” The first stages of the program include more widespread implementation of genomic testing, and funding support for genomic medicine researchers and clinicians.9
~1 in 12: Proportion of Canadians living with a rare disease10
80%: Approximate percentage of rare diseases that are caused by genetic changes10 — putting them squarely in the gene-therapy pipeline.
3,440: Number of life-years that could be gained over six years in all Canadian patients with the five highest-mortality metastatic cancers (lung, colorectal, pancreas, breast, prostate), if universal CGP was implemented.11
32%: Proportion of non-small-cell lung cancer (NSCLC) cases where CGP identifies an actionable biomarker, compared with 14% for small-panel or sequential testing.12
Almost 2/3: Proportion of Canadian oncologists surveyed who said that they could not access CGP for >80% of their patients with metastatic cancer. The single biggest barrier identified was lack of provincial funding.11
References
Personalized Medicine Coalition. The Age of Personalized Medicine. https://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_age_of_pmc_factsheet.pdf
Medline Plus. What is precision medicine? https://medlineplus.gov/genetics/understanding/precisionmedicine/definition/
US FDA. Focus Area: Regenerative Medicine. https://www.fda.gov/science-research/focus-areas-regulatory-science-report/focus-area-regenerative-medicine
US FDA. What is gene therapy? https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy
National Human Genome Research Institute. A Brief Guide to Genomics. https://www.genome.gov/about-genomics/fact-sheets/A-Brief-Guide-to-Genomics
US FDA. About Biomarkers and Qualification. https://www.fda.gov/drugs/biomarker-qualification-program/about-biomarkers-and-qualification
National Cancer Institute. BRCA Gene Changes: Cancer Risk and Genetic Testing. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet
Swain SM, et al. Targeting HER2-positive breast cancer: advances and future directions. Nat Rev Drug Discov 2022 Nov 7;22(2):101–126.
Lancement de la Politique québécoise en médecine génomique. PR Newswire. June 22, 2026. https://www.newswire.ca/fr/news-releases/lancement-de-la-politique-quebecoise-en-medecine-genomique-845313566.html
Canadian Organization for Rare Diseases (CORD). About CORD. https://www.raredisorders.ca/about/about-cord
Snow S et al. Life years gained and healthcare dollars saved. Current Oncology 2026;33:191.