SOLVD Health
SOLVD Health Receives New York State Laboratory Approval

SOLVD Health Receives New York State Laboratory Approval

Dec 26, 2024

News Release

SOLVD Health Receives New York State Laboratory Approval

SAN DIEGO–(BUSINESS WIRE)–SOLVD Health (SOLVD), a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, has received approval from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) for its San Diego-based laboratory. This approval authorizes SOLVD Health to offer AvertD® for patients in New York, empowering healthcare providers and patients with critical insights to help mitigate the risk of opioid use disorder (OUD).

The New York State Department of Health is recognized for its rigorous standards in clinical laboratory testing, ensuring that approved laboratories meet high benchmarks for accuracy, reliability, and patient safety. SOLVD Health’s AvertD®genetic test, already FDA-approved, is designed to assess individual genetic susceptibility to OUD, providing valuable information to guide personalized pain management strategies.

“Securing New York State approval is a pivotal step in our mission to expand access to genetic testing that can help address the opioid crisis,” said SOLVD Health founder and CEO Dr. Keri Donaldson. “This expansion enables more healthcare providers and patients to benefit from personalized health insights that can inform decisions about pain management and potentially prevent adverse outcomes.”

As the healthcare industry continues to seek solutions to combat the ongoing opioid epidemic, AvertD offers clinically validated genetic insights that can help them advise pain management decisions before opioid therapy begins. This approval advances SOLVD Health’s mission to translate complex biological signals into actionable patient data, empowering individuals and healthcare providers to make more informed health decisions.

About SOLVD Health
SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, SOLVD Health enables individuals and their providers to make better decisions about their health and the health of their families. SOLVD Health accomplishes this by translating complex biological signals into actionable patient data that can point the way to better health.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

SOLVD Health to Present at William Blair’s Innovator Series

SOLVD Health to Present at William Blair’s Innovator Series

Dec 10, 2024

News Release

SOLVD Health to Present at William Blair’s Innovator Series: Life Science Tools and Diagnostics

SAN DIEGO–(BUSINESS WIRE)–SOLVD Health (SOLVD), a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, announced today that its Founder and CEO, Dr. Keri Donaldson, will provide a company update and participate in a virtual fireside chat at William Blair’s Innovator Series: Life Science Tools and Diagnostics.

Dr. Donaldson’s presentation will take place on Tuesday, December 17, 2024, from 1:00 p.m. to 1:45 p.m. ET. The session will include a company update followed by a Q&A with William Blair’s Diagnostics Analyst, Andrew Brackmann. Together, they will discuss SOLVD Health’s advancements, ongoing initiatives, and the company’s vision for transforming health outcomes through innovative genetic and AI-driven tools.

William Blair’s Innovator Series is a premier virtual event that highlights some of the most dynamic and fast-growing private companies in the life science tools and diagnostics space.

The event provides investors with the opportunity to learn directly from industry leaders about cutting-edge advancements shaping the future of healthcare.

Event Details:

  • Date: Tuesday, December 17, 2024
  • Time: 1:00 p.m. – 1:45 p.m. ET
  • Location: Virtual

“We’re excited to share SOLVD Health’s progress and innovative approach to enhancing personalized health outcomes,” said Dr. Keri Donaldson. “This series is an important platform for showcasing the transformative potential of precision health solutions.”

For more information about the William Blair Innovator Series, visit the event page link.

About SOLVD Health
SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, SOLVD Health enables individuals and their providers to make better decisions about their health and the health of their families. SOLVD Health accomplishes this by translating complex biological signals into actionable patient data that can point the way to better health.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

SOLVD Health Receives New York State Laboratory Approval

SOLVD Health Launches 5-Year Post-Approval Study on Real-World Impact for AvertD® Genetic Test

Nov 18, 2024

News Release

SOLVD Health Launches 5-Year Post-Approval Study on Real-World Impact for AvertD® Genetic Test

SAN DIEGO–(BUSINESS WIRE)–SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, has launched a comprehensive post-approval study for AvertD®, the first U.S. Food and Drug Administration (FDA)-approved genetic test for assessing risk of developing opioid use disorder (OUD). This post-approval study aims to expand upon pivotal study findings and further demonstrate AvertD’s ability to enhance personalized data-driven decisions in real-world settings.

e prospective study will enroll up to 4,000 patients, integrating agile methods to gather comprehensive, real-world data from diverse demographic groups across the United States. Designed to confirm AvertD’s predictive accuracy across diverse populations, the study seeks to equip providers with critical insights for individualized, evidence-based pain management.

“The launch of our post-approval study for AvertD represents more than our commitment to regulatory requirements. It’s a commitment to addressing one of the most pressing public health challenges of our time,” said SOLVD Health Founder and CEO Dr. Keri Donaldson. “Every day, healthcare providers and their patients face challenging decisions about pain management. Our goal is to arm them with precise, personalized insights to guide these critical decisions and improve patient outcomes.”

The study will follow participants for up to five years, providing additional long-term data on the predictive value of genetic testing in OUD risk assessment. The extended timeframe will enable researchers to observe how genetic risk factors interact with environmental and behavioral influences over time, potentially uncovering new strategies for addiction prevention and intervention.

About SOLVD Health
SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, SOLVD Health enables individuals and their providers to make better decisions about their health and the health of their families. SOLVD Health accomplishes this by translating complex biological signals into actionable patient data that can point the way to better health.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

SOLVD Health to Present at William Blair’s Innovator Series

SOLVD Health Receives FDA PMA Supplement Approval for Use of INFINITI High-Throughput System with AvertD®

Nov 12, 2024

News Release

SOLVD Health Receives FDA PMA Supplement Approval for Use of INFINITI High-Throughput System with AvertD®

SAN DIEGO–(BUSINESS WIRE)–SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, has received U.S. Food and Drug Administration (FDA) PMA supplement approval for its INFINITI High Throughput System (HTS) to be used with AvertD®.

The HTS instrument expands daily processing capacity, designed to work seamlessly with SOLVD Health’s entire test portfolio, including AvertD®, the first FDA-approved genetic test for assessing elevated risk for developing opioid use disorder (OUD). The development marks a major advancement in SOLVD Health’s ability to deliver critical health insights at scale.

“This system is about more than increasing output. It’s about amplifying our impact,” said SOLVD Health Founder and CEO Dr. Keri Donaldson. “With the HTS, we’re enabling access to cutting-edge genetic insights and opening new possibilities for personalized medicine and preventive health care.”

The HTS underwent rigorous FDA evaluation to ensure it produces results consistent with the organization’s already approved INFINITI PLUS Analyzer. The HTS is a semi-automated, scalable, and multiplexed microarray analysis system that increases throughput to 960 samples in approximately 8 hours compared to 48 samples on the INFINITI PLUS. This efficiency, combined with the cost-effective and readily available DNA processing equipment, significantly enhances workflow optimization.

“This approval underscores our commitment to innovation and clinical excellence,” added Dr. Donaldson. “We’re poised to make a broader impact on critical health issues, including the opioid crisis, by making advanced genetic insights more accessible to health care providers and patients.”

The approval marks another milestone in SOLVD Health’s mission to translate complex biological signals into actionable patient data, empowering individuals and health care providers to make more informed health decisions.

About SOLVD Health
SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, SOLVD Health enables individuals and their providers to make better decisions about their health and the health of their families. SOLVD Health accomplishes this by translating complex biological signals into actionable patient data that can point the way to better health.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

SOLVD Health Receives New York State Laboratory Approval

SOLVD Health Names Chief Financial Officer and Senior Vice President of Clinical Operations

Aug 13, 2024

News Release

SOLVD Health Names Chief Financial Officer and Senior Vice President of Clinical Operations

CARLSBAD, Calif.–(BUSINESS WIRE)–SOLVD Health, a patient intelligence company focused on creating innovative technologies that identify an individual’s risk of disease by discovering and converting biological signals into predictive, contextual health insights, has appointed Mark Hazeltine as Chief Financial Officer and Ron McCullough as Senior Vice President of Clinical Operations.

Mr. Hazeltine has extensive experience in finance, operations, and strategic development. Before joining SOLVD Health, he served as Chief Business Officer at Exagen Inc., a diagnostics company specializing in autoimmune testing. At Exagen, Mr. Hazeltine held various roles in finance and corporate development, including Senior Vice President of Finance & Corporate Development, General Manager and Chief Operating Officer. He co-led the IPO process and significantly increased reimbursement rates through improved billing processes. Mr. Hazeltine holds a Bachelor of Business Administration from the University of San Diego and a Master of Business Administration from the University of Southern California.

“Mark’s proven track record of driving change, fostering growth, and providing strategic financial leadership in both startup and established healthcare organizations makes him the ideal addition to our executive team,” said SOLVD Health founder and CEO Keri Donaldson. “His deep understanding of the diagnostics industry, combined with his successful IPO experience, fundraising, and operational excellence, will be invaluable as we continue to scale our business and pursue our mission.”

Dr. McCullough is a seasoned executive with a strong background in commercializing high-potential research, clinical diagnostics, and business innovation. He served as the Chief Scientific Officer and co-founder at Intrigue Health, a medical device and digital health startup. Dr. McCullough also chaired the Strategic Advisory Board at Claire Health and served as Senior Vice President of Operations at Pathnostics. He holds a Doctor of Philosophy in molecular and cellular biology and biochemistry from Boston University, a Master of Business Administration from the University of San Diego, and a Bachelor of Science in chemistry and biochemistry from the University of Arizona.

“Ron brings a unique blend of scientific expertise, business acumen, and entrepreneurial spirit to our team,” added Dr. Donaldson. “His experience leading cross-functional teams and driving successful product development and commercialization will help us accelerate our growth and solidify our position as a leader in the industry.”

These additions come at a critical time for SOLVD Health. In December, the U.S. Food and Drug Administration approved the company’s AvertD test, making it the first genetic test authorized to assess the risk of opioid use disorder (OUD) prior to initiating opioid therapy for acute pain management. AvertD empowers physicians and patients to make more informed decisions about pain management options, supporting SOLVD Health’s mission to address pressing healthcare challenges through innovative solutions.

About SOLVD Health
SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, we are enabling individuals and their providers to make better decisions about their health and the health of their families. We accomplish this by translating complex biological signals into actionable patient data that can point the way to better health. To learn more about us, our solutions, and our career opportunities, visit us at www.solvdhealth.com.

Contacts

Media:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com