Biodesix Quality and Regulatory Executive, Brianna Phillips, to speak at upcoming RAPS and SOCRA Annual Meetings

Biodesix highlights its QA/RA leadership as Brianna Phillips presents at 2026 RAPS and SOCRA annual meetings.

Rhea-AI Summary

Biodesix (BDSX)/b) announced that Vice President of Quality and Regulatory Affairs, Brianna Phillips, will speak at the upcoming 2026 Regulatory Affairs Professionals Society (RAPS) and Society of Clinical Research Associates (SOCRA) annual meetings.Phillips leads Biodesix’s QA/RA program supporting five on‑market diagnostic blood tests and has built a full portfolio of lab accreditations over 12 years, including CLIA, CAP, NYS CLEP, ISO 13485, and FDA registrations, as well as a GMP FDA‑registered facility. Biodesix notes that its labs are among about 1,135 NYS CLEP and 7,000 CAP‑accredited labs nationwide. The company states its quality and regulatory systems help accelerate patient access to Nodify Lung and IQLung test portfolios, which have been used in the care of more than 100,000 patients.

Key Terms

good manufacturing practices, iso 13485, quality management system, regulatory compliance

4 terms

good manufacturing practices regulatory

"establishing a Good Manufacturing Practices (GMP) FDA-registered facility"

Good manufacturing practices are a set of required processes, controls and documentation that ensure products are made consistently, safely and to quality standards — like following a precise recipe in a clean kitchen so every batch turns out the same. For investors, compliance matters because it affects a maker’s ability to get regulatory approval, avoid costly recalls or production stoppages, and maintain customer and market trust, all of which influence revenue and risk.

iso 13485 regulatory

"CLIA, CAP, NYS CLEP, ISO 13485, and FDA"

ISO 13485 is an international quality management standard for organizations that design, produce, or service medical devices. Think of it as a factory’s rulebook and checklist that helps ensure products are safe, consistently made, and meet regulatory rules worldwide. For investors, certification signals lower operational and regulatory risk, easier market access, and greater reliability of a company’s medical products and supply chain — similar to buying from a trusted, inspected supplier.

quality management system technical

"the Biodesix Quality Management System and Regulatory Compliance processes"

A quality management system is an organized set of policies, procedures and records a company uses to ensure its products or services consistently meet required standards and regulations. Investors care because a strong system reduces the risk of product failures, recalls, regulatory fines and costly delays, much like a well-maintained checklist and routine for a kitchen that keeps meals safe and on schedule, protecting reputation and predictable earnings.

regulatory compliance regulatory

"Quality Management System and Regulatory Compliance processes"

Regulatory compliance is the process of ensuring that a company follows all applicable laws, rules, and standards set by government authorities or industry bodies. It is important to investors because it helps prevent legal penalties, financial losses, and reputational damage, contributing to the overall stability and trustworthiness of a business. Think of it as following the rules of a game to play fairly and avoid penalties.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Industry-leading QA/RA excellence accelerates patient access to Biodesix Lab testing, which helps improve overall outcomes for patients with lung nodules

LOUISVILLE, Colo., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostics solutions company, today announced that Brianna Phillips, Vice President of Quality and Regulatory Affairs at Biodesix, will be presenting at the upcoming Regulatory Affairs Professionals Society (RAPS) and Society of Clinical Research Associates (SOCRA) Annual Meetings.

These important professional society meetings put a spotlight on the material influence and need for Quality Affairs and Regulatory Affairs (QA/RA) expertise in the medical diagnostics segment. Under Brianna’s leadership, Biodesix QA/RA is a strategic, differentiating advantage for the company’s five on-market diagnostic blood tests. Excellence in QA/RA has helped propel Biodesix in transforming the healthcare pathway for patients with indeterminate lung nodules.

For the past 12 years, while leading the QA/RA team at Biodesix, Brianna has established the full portfolio of QA/RA accreditations for two Biodesix Labs: CLIA, CAP, NYS CLEP, ISO 13485, and FDA. She also led the company’s efforts in establishing a Good Manufacturing Practices (GMP) FDA-registered facility. Her team has completed countless successful audits by domestic auditing bodies as well as international pharmaceutical partners’ auditors.

These Lab certifications, the track record of successful audits and improvements to processes, and the high bar for excellence in quality standards are a remarkable achievement in that of the tens of thousands of labs nationally, there are only ~1,135 NYS CLEP labs and only ~7,000 CAP-accredited labs, cementing Biodesix Labs into a rare class of diagnostics peers.

At their root, the Biodesix Quality Management System and Regulatory Compliance processes are critical to accelerate patient care excellence as well as patient access to the Nodify Lung^® Nodule Risk Assessment and IQLung^® Cancer Risk Assessment testing portfolios. These tests have already impacted the lives of more than 100,000 patients in a few short years.

With her unique breadth and depth in QA/RA across multiple medical industry segments, Brianna will be sharing her expertise at these September events:

Regulatory Affairs Professionals Society (RAPS), Annual Convergence Event, Charlotte NC:

• Preconference Workshops: Regulatory Leadership Bootcamp: A Skills-Based Accelerator for Early to Mid-Career Professionals
    Tuesday, September 15, 2026, 8:30 AM - 4:00 PM EDT
• Hiring in the Age of AI: How Hiring Managers Can Assess Great Talent
   Thursday, September 17, 2026, 1:00 PM - 2:00 PM EDT

Society of Clinical Research Associates (SOCRA) Annual Meeting, Denver, CO: 

• The Power Pair: Regulatory + Clinical Development as Catalysts for Rapid, Compliant Growth
    Saturday, September 26, 2026, 10:50 AM - 11:35 AM MST. Brianna will be joined on this panel by Biodesix VP of Clinical Development, Niki Givens.

Brianna’s impact goes far beyond Biodesix and the healthcare providers and patients that benefit from the company’s blood tests today. Additionally, she offers her leadership to the next generation of QA/RA professionals as a member of the QA/RA Advisory Board for the Biomedical Engineering Department at the University of Colorado Denver | Anschutz, as Guest Professor for the Quality Certificate Program at CU Anschutz, and as Chair-Elect of the Colorado Chapter of RAPS.

About Biodesix:

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, including Nodify Lung^® Nodule Risk Assessment and IQLung^® Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit biodesix.com and KnowYourNodule.com.

Biodesix Contacts:
Media:
Natalie St. Denis, Director Corporate Communications
natalie.stdenis@biodesix.com
(720) 925-9285

Investors:
Chris Brinzey, Partner, ICR
chris.brinzey@icrhealthcare.com
(339) 970-2843