XL2 addition could mean more TLC for lung cancer screening

BOULDER, Colo.—Molecular diagnostics company Biodesix Inc. announced July 9 that it had acquired Integrated Diagnostics Inc. (Indi), a Seattle-based company developing blood-based molecular diagnostics. Financial terms of the deal were not disclosed, but the company did make a point of noting that the agreement includes the XL2 test, Indi’s lead oncology product, which offers a noninvasive means of ruling out cancer for patients with suspicious lung nodules.

“The team at Indi has developed and substantially validated an important test that helps physicians better manage patients who present with a suspicious nodule in their lung,” said David Brunel, CEO of Biodesix. “Adding XL2 to our portfolio demonstrates our commitment to helping physicians and patients battle lung disease across a continuum of clinical presentations.”

As Biodesix notes, healthcare providers in the United States alone discover more than 1.6 million lung nodules in patients each year—the problem is that a significant portion of these patients need to undergo a challenging, invasive and costly procedure to extract a tissue sample from the nodule to determine whether it is malignant or benign. The XL2 test, which requires a simple blood draw, is a pulmonary nodule classifier that measures proteins to identify lung nodules that have a high probability of being benign.

Not that Biodesix was any novice in this diagnostic realm itself before the acquisition of Indi and its XL2 product. The Biodesix VeriStrat proteomic test, the company notes, provides objective prognostic information independent of treatment choice, including immunotherapy, and the GeneStrat genomic test measures actionable mutations for non-small cell lung cancer to further inform therapeutic decisions and monitoring.

“XL2 is a perfect complement to our existing commercial blood-based lung cancer tests, which make use of advanced proteomic and genomic technology to support more informed treatment decisions,” said Scott Hutton, chief operating officer of Biodesix.

“We’ve been actively exploring the optimal path to bring XL2 to the market since 2017, when we validated our test,” noted Dr. Al Luderer, CEO of Integrated Diagnostics. “Indi and Biodesix share important values and technologic synergies that make this an ideal combination, including a singular focus on providing high-value, blood-based diagnostic products for lung disease and the expert application of advanced mass spectrometry and informatics. Additionally, we are impressed by Biodesix’s rapidly expanding commercial presence and extensive lung disease product pipeline.”

The lung cancer testing news of this acquisition is complemented—and preceded—by some other recent Biodesix news of new data presented at the American College of Medical Quality 2018 conference. The data reportedly demonstrate that the Biodesix VeriStrat test reliably assesses individual patient prognosis to inform treatment decisions and reduce costs associated with overtreatment in lung cancer—specifically, these data indicate that the test provided objective prognostic information that altered physicians’ treatment decisions, independent of patient performance status.

“In the absence of objective prognostic information, patients and physicians often will opt to continue treating lung cancer with systemic medications,” explained Brunel. “Knowing that for some patients, benefit from these medications is unlikely, patients and their healthcare team who are armed with this information may opt instead to focus on improving quality of life. These prognostic conversations and any alternative, shared treatment strategies can have many benefits for patients, their families, physicians and the healthcare system.”

The VeriStrat test is intended to help guide treatment decisions for patients with non-small cell lung cancer (NSCLC). VeriStrat classifies patients into two categories: “VS Good” and “VS Poor.” Patients classified as VS Good have a favorable prognosis and benefit from receiving active treatment, whereas patients classified as VS Poor have a less favorable prognosis and may not derive typical benefit from standard-of-care therapies.

In patients with a poor performance status, VeriStrat results can impact the decision to pursue treatment for patients classified as VS Good, as well as the decision to refer patients with VS Poor test results to alternative treatment strategies, including BSC. Optimizing BSC and avoiding overtreatment creates an expected pharmaceutical expenditure savings of $955 per patient within the first 30 days of treatment.

As part of the ongoing prospective INSIGHT observational trial, physicians provided treatment recommendations prior to VeriStrat testing and actual treatment selections after receipt of VeriStrat results for NSCLC patients. At Medical Quality 2018, Biodesix researchers presented a subgroup analysis that evaluated the impact of VeriStrat test results on treatment decisions for 151 patients with Eastern Cooperative Oncology Group (ECOG) performance status scores of 2 to 4 at time of study entry. This subgroup was chosen because these patients are more impacted by their disease and have poorer daily functioning scores than patients with ECOG scores of 0 to 1.

In this subgroup, VeriStrat testing classified 58 percent of patients as VS Good and 42 percent as VS Poor. As expected, there was a significant difference in treatment plans, with a smaller portion of VS Good patients referred to BSC than VS Poor patients (9 percent and 23 percent, respectively, p=0.027). VeriStrat remained a significant predictor of referral to BSC regardless of ECOG status in a multivariate analysis.

In the cohort of patients with ECOG scores of 3 to 4 (i.e., those with the poorest performance status), the difference in treatment plans was larger: 9 percent of VS Good as opposed to 58 percent of VS Poor patients were referred to BSC (p=0.041).

“VeriStrat results can impact the frequency of follow-up, clinical trial enrollment, as well as the degree or timing of supportive and palliative services offered,” said Brunel. “This study supports the use of VeriStrat as a valuable prognostic tool independent of performance status, helping to inform physician and patient conversations, optimizing timing of palliative care and decreasing overtreatment when possible.”