Ausel Cancer Innovation, a clinical-stage healthcare company developing novel cancer diagnostic technology, has begun enrollment in its final study in the EU in patients with breast and lung cancers.
Ausel Cancer Innovation, a clinical-stage healthcare company developing novel cancer diagnostic technology, has begun enrollment in its final study in the EU in patients with breast and lung cancers.
Ausel is developing a novel, saliva-based early cancer detection in vitro diagnostic designed to indicate the presence of cancer cells at the earliest stage of development, when treatments can be the most effective at intervening or curing the disease. This test differentiates itself through using simple metabolites instead of free-floating cells or their genetic material shed by tumors. The test can be done in any doctor’s office with no need for special equipment or facilities.
Breast and lung cancers are life-threatening cancers whose patients can benefit from early detection. Early detection has significantly increased the 5-year survival rates for both cancers, but substantial room for improvement exists in early detection across these and all cancer types. There remains a high unmet need for more efficacious detection methods for cancers in patients not yet exhibiting symptoms.
“The commencement of enrollment for our final study is a major milestone in the development of our technology, and this brings us one step closer to enhancing the early detection of many cancers,” said Nick Ainslie, Manager of Ausel.
“We are grateful for the patients, researchers, Science Advisory Board, and institutions who have worked with us to help advance this diagnostic which may completely shift the paradigm of early cancer detection. It is our hope that we can significantly improve the outcomes for our patients by improving the timing of effective treatments.”
Patients for this study are being enrolled in Italy.
The primary endpoint of the study is final validation of the diagnostic in patients with Lung and Breast cancers and submission for EU approval. A related study consisting of a broad range of cancers in 100 patients will be conducted in parallel to expand the scope of the diagnostic beyond breast and lung cancers.
Dr. Prisco Piscitelli, Ausel’s CMO and Head of Experimental Medicine at University of Salento, Italy, commented: “It is with great pleasure that I await the results from the successful completion of both the final clinical study and parallel study.”
“The first and second studies reported exceptional data on both efficacy and sensitivity. The third and final study of this novel early cancer diagnostic has the potential to transform the detection and treatment timelines for cancer patients and directly impact the health outcomes of these individuals.”
Ausel Cancer Innovation has operated in stealth mode until today.
“The finish line is rapidly approaching with our early cancer diagnostic kit and filing for our EU market approval,” said Robert Ainslie, co-founder. “We are here in fond memory of the late Dr. Pietrina Romano, the pioneering biochemist whose many years of research led to the breakthrough discovery for the early cancer detection using a sample of a patient’s saliva.”
For inquiries: nick@ausel.life