The American Cancer Society estimated that 222,000 new cases of lung cancer were diagnosed in the United States in 2010, representing 15% of all cancer diagnoses. An estimated 157,000 deaths occurred from this disease, representing 28% of all cancer deaths. Worldwide, 1.6 million new cases of lung cancer are diagnosed each year, with 1.3 million deaths from the disease. Four major market areas, US, Europe, Japan, and China, contribute 79% of the worldwide cases of lung cancer. Seventy percent of lung cancer patients are diagnosed with late-stage disease and most die within five years, illustrating the importance of early diagnosis in reducing mortality, as well as potentially reducing healthcare costs.
Allegro’s product candidates utilize the company’s proprietary molecular testing approach, analyzing gene expression in airway epithelial cells to detect early signs of lung cancer. This “field of injury” principle refers to the changes that occur in all airway epithelial cells of current and former smokers with lung cancer, such that a gene expression signature from non-malignant airway cells can indicate the presence of malignancy in the lung. This approach has been shown to increase the accuracy of lung cancer diagnosis in current and former smokers over standard diagnostic techniques currently employed.
The BronchoGen genomic test is intended to bring early detection to the standard of care for lung cancer. While approximately 300,000 bronchoscopic exams are ordered each year for suspected lung cancer, 50-75% of these tests are inconclusive. As a result, a definitive diagnosis is not provided in the majority of cases.
BronchoGen has the potential to be incorporated into standard bronchoscopy procedures, providing additional critical diagnostic information to support more rapid diagnosis and treatment. This approach not only may decrease the risk of diagnosing cancer in late stage, but may also result in fewer referrals for surgery of benign disease, which currently comprises 20% of all referrals to surgery. Use of BronchoGen may allow the physician to discriminate more effectively between patients at high risk for lung cancer and those at lower risk, thus potentially reducing the number of diagnostic and surgical procedures required to manage those patients.
Allegro is currently managing a multi-center trial to validate the use of BronchoGen as an aid to diagnose lung cancer.
In addition to BronchoGen, Allegro is advancing other product candidates focused on early detection of lung cancer, all of which are based on the company’s proprietary molecular testing platform. One such product candidate is a non-invasive genomic test performed on cells from the nasal passage.