Biodesix has acquired Seattle-based Integrated Diagnostics and its precommercial XL2 lung cancer blood test, which aims to help physicians rule out the patients that do not need to have a biopsy of a suspicious lung nodule. The financial terms of the deal were not disclosed.
Integrated Diagnostics has been actively exploring paths to bring XL2 to the market since it began validating its test last year, said CEO Al Luderer, who cited Biodesix’s focus on noninvasive, blood-based diagnostics for lung disease, as well as its established portfolio of commercial tests, as making it an attractive partner.
Biodesix estimates that healthcare providers discover more than 1.6 million suspicious nodules in the U.S. annually, with many of them being referred for biopsies. If the blood test returns as benign, then the patient can have a follow-up CT scan in 3 to 6 months, Biodesix CEO David Brunel told FierceMedTech.
“Right now there’s an increasing number of patients going through screening programs, or through typical procedures that end up finding incidental nodules,” Brunel said.
“The problem is that the vast majority of these patients don't have cancer,” he said. “And so rather than overwhelm the healthcare system with a lot of biopsies, it’s very useful to have a test that helps the doctor manage that patient population more effectively.”
The XL2 test would ideally complement the tests that Biodesix already has on the market, adding a new point-of-diagnosis product compared to its VeriStrat and GeneStrat proteomic and genomic tests, which are used for therapeutic guidance in typically later-stage patients.
A previous clinical trial of the XL2 test showed that, among low- to moderate-risk patients, the test was 98% effective at differentiating benign lung nodules from malignant ones, using proteins found in the bloodstream.
Biodesix is planning an additional registry study to further validate the test later this year, expected to enroll around 500 patients, to gauge patient outcomes and changes in physician behavior.
“When that study completes, then we'll really ramp up commercialization,” Brunel said.