Biodesix Announces the Launch of its GeneStrat NGS™ Test and the IQLung™ Testing Strategy with Unprecedented Time to Results

Rhea-AI Summary

Biodesix has launched its new GeneStrat NGS™ genomic test, a blood-based tumor profiling tool designed to assist in identifying targeted therapy mutations for advanced-stage lung cancer patients. This test features a 52-gene panel and offers results within an expedited 72 hours. The GeneStrat NGS test is covered by Medicare and is part of the larger IQLung™ Treatment Guidance Testing Strategy aimed at improving treatment decision-making. CEO Scott Hutton emphasizes the importance of timely results for enhancing patient outcomes.

Positive

• Launch of GeneStrat NGS™ test, a blood-based tumor profiling tool.
• Test provides results in an expedited 72-hour timeframe.
• Covered by Medicare under National Coverage Determination.
• Part of comprehensive IQLung™ testing strategy aimed at improving patient outcomes.

Negative

• None.

Genomic and proteomic diagnostics for lung cancer help physicians better identify patients eligible for targeted therapy or clinical trial enrollment

BOULDER, Colo.--(BUSINESS WIRE)-- Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today the national launch of its new GeneStrat NGS™ genomic test, a blood-based tumor profiling test. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced- stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

The GeneStrat NGS test is paired with advanced variant interpretation technology connected to a powerful knowledge database developed by PierianDx. Physicians will now receive a streamlined report, including genomic insights for more precise patient care in an unprecedented 72-hour turnaround time.

The GeneStrat NGS test is paid by Medicare under the National Coverage Determination (NCD) for NGS Manual 90.2 section D by Novitas Solutions.

The Company also announced the launch of its new IQLung™ Treatment Guidance Testing Strategy, which includes the new GeneStrat NGS and a broader view of each patient’s disease state. The testing strategy also includes blood-based proteomic and genomic testing workflows for both early and advanced stage lung cancer that can aid physicians in making treatment decisions. Biodesix plans to add additional tests in development to their IQLung portfolio.

“Initiating treatment as early as possible can help improve patient outcomes,” said Scott Hutton, CEO, Biodesix. “Studies show the length of time to receive tests results impacts how quickly a patient goes on treatment. Current NGS tests can take anywhere from a week to a month to return results. This delay of diagnostic information contributes to patient anxiety and compliance, further delaying treatment when time is imperative in fighting lung cancer. It is our mission to change this paradigm, and we offer tests that provide important results in three days so patients can begin treatment as swiftly as possible.”

About Biodesix
Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer eight non-invasive tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19. For more information about Biodesix, visit biodesix.com.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of the COVID-19 pandemic on Biodesix and its operations, it is possible or assumed future results of operations, including descriptions of its revenues, profitability, outlook, and overall business strategy. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix’s most recent annual report on Form 10-K, filed March 16, 2021, or subsequent quarterly reports on Form 10-Q during 2021, if applicable. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220118005460/en/

Media:

Bobbi Coffin

bobbi.coffin@biodesix.com

(303) 892-3203

Investors:

Chris Brinzey

chris.brinzey@westwicke.com

(339) 970-2843

Source: Biodesix, Inc.

FAQ

What is the GeneStrat NGS™ test by BDSX?

The GeneStrat NGS™ test is a blood-based tumor profiling tool designed to identify targeted therapy mutations for advanced-stage lung cancer patients.

How quickly can results be obtained from the GeneStrat NGS™ test?

Results from the GeneStrat NGS™ test can be obtained in an expedited timeframe of 72 hours.

Is the GeneStrat NGS™ test covered by insurance?

Yes, the GeneStrat NGS™ test is covered by Medicare under the National Coverage Determination.

What is the purpose of the IQLung™ Treatment Guidance Testing Strategy?

The IQLung™ Treatment Guidance Testing Strategy includes various tests to aid physicians in making informed treatment decisions for lung cancer patients.

Who is the CEO of Biodesix and what did he say about the new test?

Scott Hutton is the CEO of Biodesix, and he emphasized that initiating treatment as early as possible can improve patient outcomes.