A company developing a method for detecting lung cancer earlier, when it’s more treatable, has closed a Series A financing round of $4 million. Allegro Diagnostics, of Boston, raised the money from Kodiak Venture Partners, Catalyst Health Ventures, and Boston University, where the technology was developed.
The money will go toward a second clinical study aiming to validate Allegro’s system of diagnosing lung cancer by testing cells in the airway for genetic markers. A previous study testing the technique among smokers with suspected lung cancer—which showed it boosted the sensitivity of bronchoscopy, a typical initial diagnostic procedure, from 53 percent to 95 percent—was published in the journal Nature Medicine last March. The new study should start in the middle of this year, enroll about 300 patients, and last 12 to 24 months, says Allegro CEO Dan Rippy.
“When you try to go market these kinds of products, the clinical community likes to see two different studies in two different patient populations,” Rippy says. Once the study is complete, he hopes to win Food and Drug Administration approval for the diagnostic test within about six months.
The testing technology was developed by Jerome Brody, Director of the Pulmonary Center at Boston University School of Medicine, and Avrum Spira, adjunct professor of bioinformatics at BU’s medical school. Brody recently left his post at the school to become Allegro’s chief scientific officer, and Spira acts as scientific and clinical advisor to the company.
The test works by taking a sample of cells from the lining a patient’s airway and examining their RNA to see if certain genes are being either over- or underexpressed. Rippy says not only can the technique diagnose the presence of lung cancer, it can also help characterize the type of disease found and determine what stage of development it’s reached. If they can catch patients in the first stage of the disease, doctors can cure them by surgically removing the diseased tissue about 70 percent of the time.
Unfortunately, with current techniques, such early catches happen rarely. “Most patients present with the disease as such a late stage, there is little to be done for these patients,” Rippy says. “Most lung cancer patients today will die within five years.”
With more than 200,000 new cases of lung cancer being diagnosed every year in the US, according to the American Cancer Society, that’s a significant “most.” It’s the leading cancer killer, causing more deaths than colon, prostate, breast, and ovarian cancer combined.
Preliminary diagnosis these days is often done by inserting a bronchoscope up the nose or down the throat into the lungs, and visually checking for abnormal tissue. CT and PET scans and needle biopsies are often additionally needed to make a definitive diagnosis. Sometimes, however, the wait for the more definitive tests can be months, Rippy says, and the cancer can get much worse in the meantime. With Allegro’s technique, a doctor using a bronchoscope would insert a tiny brush down the tube to capture some cells, which could then be tested in the lab for genetic signs of disease with results in just a few days. At some point, Rippy says, doctors might want to consider using the test to screen high-risk groups, such as smokers, potentially catching cancer even earlier.
Brody and Spira founded the company in 2006 as ExProDx, with a $175,000 grant from Boston University’s new Launch Award program, created to give BU technologies a leg up. The company has “a portfolio of intellectual property that originated within BU,” Rippy says, along with three full-time and three part-time employees.