Biodesix Announces First System-Wide Integration of Nodify XL2 Testing for Lung Nodule Management

BOULDER, Colo.--(BUSINESS WIRE)-- Biodesix, Inc. the leader in lung cancer diagnostics, today announced that Tri-Star Health in Nashville, TN, the region's largest, most comprehensive healthcare provider, is the first hospital system in the U.S. to adopt the recently launched Nodify XL2™ proteomic nodule classifier for incidental lung nodule management. 1.6 million lung nodules are detected incidentally each year in the U.S., but fewer than five percent turn out to be malignant. In order to prevent unnecessary invasive diagnostic procedures, Tri-Star Health has adopted routine Nodify XL2 testing to help stratify patients by risk of malignancy using a simple blood draw.

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“Inside a lung nodule clinic, we focus on first assessing the risk of malignancy to inform decisions about whether more invasive procedures are needed. Patients want information that impacts clinical decision making in a timely manner and the Nodify XL2 test results give physicians the opportunity to have very personal discussions with each patient on the best course of action,” said Susan Garwood, M.D., Pulmonary and Advanced Bronchoscopy Lung Cancer Specialist with Centennial Medical Center in Nashville, part of the HCA TriStar division. “This new blood test provides results in five days without an invasive bronchoscopy or waiting six months for a follow-up CT scan. In my experience, Nodify XL2 has been simple to integrate into my clinical assessment and our clinic’s workflow.”

The Nodify XL2 test is easy to use; blood can be drawn in the doctor’s office and sent overnight to the Biodesix lab for processing. The test is covered by Medicare and has been clinically validated in the PANOPTIC study where the test demonstrated a 98% median negative predictive value and a potential 40% reduction in invasive procedures on benign nodules.

“The impact of knowing that you have a nodule that could be cancerous is terrifying,” said Tresia Michael, LPN, Lung Nodule Coordinator for Tri-Star Health. “When patients come into our clinic, their life stops. I would say 100% of them experience extreme anxiety wondering how this will impact their family, their work, fear of an invasive procedure, or monitoring and fearing the unknown. Being able to offer the Nodify XL2 blood test has greatly reduced anxiety and allows us to instill greater confidence in our medical recommendation.”

Cathy Graham hoped for the best but feared the worst. As a busy nurse and mother, Cathy hadn’t thought much about the breast implants she received after reconstructive surgery 38 years ago. Concerned the implants could be leaking her physician ordered an X-ray and discovered something worse, lung nodules. She was referred to Dr. Garwood, who used the Nodify XL2 blood test to help assess the likelihood of Cathy’s nodules being cancerous. The test results reaffirmed Dr. Garwood’s assessment that Cathy was at low risk of developing lung cancer. “It was a very simple blood draw and I was relieved when my results came back as low risk. Even though I am a nurse, going in for scans and not knowing is scary,” said Cathy.

“The early success and adoption of the Nodify XL2 test is a clear sign that we are filling an unmet need by providing physicians and patients with a blood-based test that provides rapid results to help in the clinical assessment of lung nodules,” said Scott Hutton, chief operating officer, Biodesix. “We take lung cancer personally and by understanding the frightening experience of people who have been told they have a lung nodule, we have leveraged our experience in biomarkers to help physicians find the right path forward, quickly.”

To see how the Nodify XL2 test is being used in a medical practice visit this link.

About Biodesix

Biodesix is a lung cancer diagnostic solutions company covering the continuum of patient care from early risk classification of lung nodules through treatment guidance in late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics through the power of artificial intelligence. Biodesix is the first company to offer four best-in-class non-invasive tests for patients with lung cancer or suspicious lung nodules. The Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. The Nodify XL2™ test and the EarlyCDT LungTM test evaluate the risk of malignancy in incidental pulmonary nodules, enabling physicians to triage patients to the most appropriate course of action. The company’s strong product pipeline addresses key clinical questions in all stages of lung cancer, from risk assessment of early stage disease to informing treatment decisions for emerging therapies. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com.

Contacts

Kena Hudson for Biodesix
Kena@HudBio.com
(510) 908-0966

 
 

Source: Biodesix, Inc.

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