Allegro Diagnostics

About Allegro Diagnostics

Allegro Diagnostics, founded in 2006, operated as a molecular diagnostics company focused on genomic testing for lung cancer. The company's technology was originally developed at the Pulmonary Center at Boston University School of Medicine. Key figures associated with the company included founders Jerome Brody, MD, who also served as Chief Scientific Officer, and Avrum Spira, who acted as a Scientific and Clinical Advisor. Over its history, Allegro Diagnostics secured a total of $9.4 million in funding across four rounds, which included both venture capital and grants from institutions like the National Cancer Institute. Its investor base included Kodiak Venture Partners, CHV (Catalyst Health Ventures), and Boston University.

The company's core business centered on developing and commercializing genomic tests to facilitate the early diagnosis, staging, and treatment of lung cancer and other pulmonary diseases. Allegro's business model was based on its molecular testing platform that analyzed gene expression changes in the airway's epithelial cells, which are linked to lung cancer development in smokers and former smokers. The primary product was the BronchoGen™ test, a genomic assay designed to be used with standard bronchoscopy procedures. This test analyzed cytologically normal airway cells to detect a gene expression signature correlated with malignancy elsewhere in the lung. The main benefit of BronchoGen™ was to improve the diagnostic accuracy for patients with inconclusive bronchoscopy results for lung nodules, helping physicians determine which patients were at low risk for cancer and could be monitored with CT scans instead of undergoing more invasive and costly procedures. Clinical trial data demonstrated that combining BronchoGen™ with bronchoscopy significantly improved the sensitivity of cancer detection.

A significant milestone for the company was the successful clinical validation of the BronchoGen™ test in the AEGIS I trial, which met its primary endpoint. This achievement paved the way for the company's strategic exit. In September 2014, Veracyte, a molecular cytology firm, acquired Allegro Diagnostics for $21 million in a deal comprising cash and stock. The acquisition was aimed at accelerating Veracyte's entry into the pulmonology market by leveraging Allegro's validated lung cancer test. Following the acquisition, Veracyte planned to integrate Allegro's operations and commercially launch the test from its own CLIA lab.