“I am really as much a patient advocate as I am a technology developer and business person. I really want to change the way we diagnose and treat patients.” – Gitte Pedersen
“We are at this tipping point, where we need to move away from this static treatment model where we have one disease, one marker, and one drug.” – Gitte Pedersen
“Because of the very short timeframe from code to product, and I’m talking about months here, instead of trying this out on 10,000 patients, if it works for you, that’s good enough.” – Gitte Pedersen
Advanced cancer patients search for treatment options beyond the standard of care (surgery, radiation, chemotherapy, hormone deprivation therapy). Only one in four cancer patients live longer if they just follow the standard of care. To go beyond the standard of care, they usually get DNA sequencing and match with one or more drugs which target their unique biomarkers. Transcriptomics is the analysis of a patient’s RNA for additional biomarkers that could indicate other possibilities for targeted drugs and guidance to the best treatment options.
Gitte Pedersen is in a unique position to help cancer patients and their families evaluate whether RNA analysis can open up a new avenue for treatment options. Gitte is a scientist and company builder. As a scientist, she is a co-author on eight patents and previously worked at Novo Nordisk. As a company builder, she is the founder and CEO of Genomic Expression, “an RNA platform for next generation cures. By analyzing RNA they can detect disease, monitor health, and design next generation cures.” Her passion is driven by helping her parents, who both were diagnosed with lung cancer. She and her brother, co-founder Morten Pedersen, were frustrated, knowing that their parents were facing “evidence-based death” because there was no cure. If they just did what they were supposed to based on what the doctor said, they wouldn’t live very long.
Why is it important for advanced cancer patients to identify more biomarkers to help them in their treatment decisions?
Typical cancer patients get DNA sequencing of their tumor tissue. The tests look at up to 500 genes (an “oncopanel” of “driver” genes). These tests find an actionable biomarker in 40% of patients. For an advanced cancer patient, where 20% identify an actionable biomarker, that translates into better outcomes for 8% of the patients. We need to identify more biomarkers which will generate more treatment options. RNA (and protein) analysis can identify more biomarkers.
Why is RNA analysis useful?
Gene expression is the process by which the information encoded in a gene is turned into a function. DNA analysis (based on DNA sequencing) shows what is coded, and therefore what is possible. RNA analysis (based on RNA sequencing) shows what’s going on. We can read the program that the cell is operating on and determine whether the cells are healthy or sick.
Why is RNA analysis hard?
- RNA in clinical samples is not stable. It’s not supposed to be stable. It’s a dynamic molecule. RNA is destroyed in most samples because the typical way they treat the tissue is to dunk it in formalin and embed it in paraffin, so that pathologists can slice it up, stain the cells, and look at them under a microscope.
- You have to compare the RNA sequencing data for a patient to a benchmark to say whether it’s high (overexpressed) or low (underexpressed).
- Once you have a list of abnormal gene expressions (biomarkers), you have to translate them into treatment options, personalized for each patient. One of the biggest questions cancer patients have is whether a particular treatment is going to work. To develop predictive algorithms, we need “big data” which tracks treatments and patient outcomes.
How will RNA therapeutics change cancer treatment in the future?
Very soon advanced cancer patients will be able to access personalized cancer treatments using RNA technology. Vaccines leveraging RNA (based on the success of BioNTech and Moderna for the COVID vaccines) are now in development for cancer. The time from code (DNA and RNA sequencing) to creating a personalized drug using DNA printing, which can be translated from DNA to RNA, is shrinking (to months).
How can patients access RNA analysis?
First, you need a physician order.
Second, reimbursement is problematic. New tests take a long time to get reimbursed by health insurance companies. There is a code for any next-gen-sequence-based test. It doesn’t define whether that is RNA or DNA, as long as it has more than 50 genes. So technically, you should be able to get your insurance company to pay for it. It doesn’t mean that they will. Of course, if you are willing and able to pay out-of-pocket, then there is no payment problem.
How will advances in liquid biopsies change cancer monitoring and treatment?
Cancer patients want to know if a treatment works fast, and they want to know for how long (e.g., if their cancer is progressing). New developments in liquid biopsies will enable nearly continuous monitoring, less invasively, and a lower cost than scans. Blood is one biospecimen. Researchers are also looking at self-collected samples in saliva and urine. Urine has been used to monitor bladder cancer, and could be used to detect prostate cancer. Saliva can detect lung, head and neck, and breast cancer. Pee in a cup or spit in a tube, send it to a lab, and they can send results back to you. If your marker starts rising, you can get a confirmatory test (proteomics, scan, or immunohistochemistry), or it may be enough to guide a treatment decision.
The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Prostate Cancer Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action. You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health.