A proven molecular diagnostic that helps oncologists better manage cancer
It was when Wren founder Dr. Irvin Modlin first asked, “How do we know we’ve excised all of a NET when we operate?” that utilizing molecular information in a blood sample as a window into neuroendocrine tumor activity first occurred to him.
It was a question he had pondered from his early days as a gastrointestinal surgeon right up to the time he served as Vice Chairman of the Yale University School of Medicine Department of Surgery in New Haven.
It was also at Yale where Modlin met Wren Scientific and Laboratory Director Dr. Mark Kidd. Dr. Kidd had been studying the molecular pathophysiology of gastrointestinal neuroendocrine cells as an NIH-funded research scientist at Yale’s Gastric Surgical Research Group.
SCIENTIFIC MILESTONES
Key Moments in the Development of Our Science
It was at Yale University School of Medicine where Dr. Modlin met Dr. Mark Kidd, and where their shared interest in neuroendocrine tumor biology served as a foundation to put them on the path to creating a better way to diagnose residual NET tumor presence after surgery.
In 1996, Modlin and Kidd collaborated on their first peer-reviewed paper discussing neuroendocrine cell secretion behavior, laying the foundation for over 200 papers, presentations, and studies on the application of molecular diagnostics in the detection, characterization, and treatment monitoring of NETs.
Two decades of collaboration between Modlin and Kidd–and a host of other researchers, scientists, and oncologists–yielded the answer to Dr. Modlin’s question, provided a proven methodology to diagnose NETs, and served as the foundation to establish Wren Laboratories in June of 2014.
OUR MOLECULAR SCIENCE
mRNA as a NET Biomarker
Biomarkers are indicators produced by tumor cells that can be detected in blood or other bodily fluids and signal the presence of cancer. Commonly used protein biomarkers for neuroendocrine tumors and other cancers are not specific and typically signal other conditions. This is where mRNA as a biomarker comes into play.
We Focus on mRNA
Messenger RNA, or mRNA, are genetic molecules expressed by cells and found in a patient’s bloodstream. Human cells have about 22,000 different mRNAs that help control a wide variety of operations. Cancer cells also produce mRNA molecules and while they are aberrantly expressed, they provide unprecedented information about tumor biology which can be used to characterize a tumor and demonstrate how it is responding to therapy.
More Robust than Medical Imaging
Medical imaging techniques like CTs, MRIs, or PETs offer a static view to determine tumor presence. In contrast, our mRNA-based methodology provides dynamic and precise information about tumor behavior in real-time, aiding in prediction. Blood-based mRNA diagnostics surpass traditional protein biomarkers in accuracy, sensitivity, and specificity, often being 2–10 times more precise.
Our COVID-19 Test
The Versatility of mRNA
Applicability beyond blood & cancer
While the first diagnostic we created utilized mRNA found in blood as a biomarker for neuroendocrine tumors, we have proven the versatility of our approach by creating diagnostics for other cancers, other types of disease as well as diagnostics that use saliva instead of blood.
An example of this is our COVID-19 diagnostic. In 2019, we set out to create an mRNA-based diagnostic to detect SARS-CoV-2, the COVID-19 virus. We focused on saliva – a safer, more convenient and painless sample to produce. In October of 2020, our COVID-19 test received an FDA emergency use authorization and was embraced by patients and doctors alike.
The accuracy of our saliva-based COVID-19 test is greater than 99%.
How it works
mRNA Collection, Isolation, and Amplification
Blood Sample is Collected
After a doctor consult, our process begins with a simple, relatively painless blood draw at a local lab.
Sample Shipped to Wren Laboratories
The sample, mixed with our proprietary buffer solution, is stabilized and protected during transit.
mRNA Isolation
We isolate the mRNA, a process enabled by our buffer, which facilitates the breakdown of the cellular membrane.
Amplification
The mRNA is reverse transcribed into cDNA and then amplified using PCR with gene-specific primers.
The Art of the Algorithm
Analyzing the mRNA sample
After qPCR, the analysis of the processed test sample begins.
We use a proprietary suite of algorithms that have been constructed with anonymized patient data from over the last two decades. We employ Artificial Intelligence to identify potential molecular signatures, cross-referencing them with clinical and scientific data.
Our NETest, for example, measures the expression levels of 51 genes that are specifically associated with neuroendocrine cancer.
Our final gene panels are selected using artificial intelligence, and then assessed by our scientific experts and validated by our lab technicians.
The NETest Score provides accurate, clear and clinically useful information about the disease state of a neuroendocrine tumor.