SOLVD Health
SOLVD Health CEO Named Clinical Scientist of the Year by the Association of Clinical Scientists

SOLVD Health CEO Named Clinical Scientist of the Year by the Association of Clinical Scientists

Jun 1, 2021

News Release

SOLVD Health CEO Named Clinical Scientist of the Year by the Association of Clinical Scientists

Dr. Keri Donaldson was recognized by his peers for his outstanding contributions to clinical science in research, teaching, and service.

CARLSBAD, Calif., June 1, 2021 – Keri Donaldson, MD, the CEO and founder of SOLVD Health, a privately held company focused on preventing disease by making actionable and contextual health information accessible to everyone, was recently named Clinical Scientist of the Year by the Association of Clinical Scientists (ACS).

Each year, the Awards Committee selects a Fellow of the Association to receive the annual Sunderman Award, which is named in honor of Dr. F.W. Sunderman, Sr., the Association’s founder. The recipient is selected by their peers for making outstanding contributions to clinical science in research, teaching, and service, and is designated the Clinical Scientist of the Year.

Dr. Donaldson is the current president of ACS and has dedicated his medical career to improving people’s lives through advancements in pathology, genomics, and diagnostics. Prior to founding SOLVD Health, he directed numerous clinical laboratories and has held key positions within respected institutions including University of Pennsylvania, Penn State Health, and Temple University. In addition, he is active in numerous national committees and professional societies focused on improving diagnostic testing and patient care. He holds an MD from Temple University School of Medicine and a Master of Science in Clinical Epidemiology (MSCE) from the University of Pennsylvania School of Medicine.

ACS was formed in 1949 to promote education and research in clinical science. Overarching goals of the Association include improving laboratory testing and encouraging cooperation among health professionals in the application of scientific methods in clinical practice and research.

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.

Media Contact:
Valerie Melucci; pr@solvdhealth.com 

 

SOLVD Health Prepares to Launch Clinical Study of Non-Invasive Colorectal Cancer Screening Test

SOLVD Health Prepares to Launch Clinical Study of Non-Invasive Colorectal Cancer Screening Test

Dec 28, 2020

News Release

SOLVD Health Prepares to Launch Clinical Study of Non-Invasive Colorectal Cancer Screening Test

LifeKit® Prevent is the only non-invasive colorectal cancer screening test designed to accurately detect the earliest warning signs of cancer—precancerous adenomas.

CARLSBAD, Calif., January 6, 2021 – SOLVD Health, a privately held company focused on preventing disease by making actionable and contextual health information accessible to everyone, is preparing to launch a U.S. clinical study of its non-invasive colorectal cancer (CRC) screening test, LifeKit® Prevent. The test is being developed in partnership with Metabiomics, a subsidiary of SOLVD Health. The PREVENT study protocol is now available on the U.S. National Library of Medicine’s ClinicalTrials.gov database, which includes privately and publicly funded clinical studies conducted around the world.

LifeKit Prevent is a qualitative in vitro diagnostic test that is designed to detect and analyze microbial genomics biomarkers in human stool samples that are strongly associated with specific stages of CRC progression. The test is intended to aid in the detection of precancerous and cancerous lesions (colorectal neoplasia), including advanced adenomas and carcinomas, in an average-risk screening population in accordance with recognized screening guidelines.

When compared to currently available options, LifeKit Prevent is the only non-invasive CRC screening test designed to accurately detect the earliest warning signs of cancer—precancerous adenomas. In an effort to prevent cancer from developing, when adenomas are detected, the patient will undergo a colonoscopy, and the adenomas will be removed.

“Colonoscopy is the current gold standard for colorectal cancer screening because it accurately detects cancer as well as precancerous adenomas,” said Keri Donaldson, MD, CEO of SOLVD Health. “However, because it is highly invasive, patient compliance rates are poor. Currently available non-invasive alternatives have been shown to effectively detect cancer, but not precancerous adenomas. Early research has shown that our test is effective at detecting both, which could be a gamechanger for colorectal cancer screening.”

Research published in BMJ Open Gastroenterology showed that LifeKit Prevent is able to accurately detect precancerous colon polyps, achieving >80% accuracy. In 2019, the test received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) due to its potential to provide more effective diagnosis of a life-threatening disease and offer significant advantages over existing alternatives.

SOLVD Health’s prospective clinical trial will enroll up to 12,000 individuals to validate its test for the detection of colorectal cancer and adenomas. Subjects will include adults at average-risk for colorectal cancer between the ages of 45 and 84.

About Colorectal Cancer

Despite being one of the most preventable forms of cancer, colorectal cancer is the second leading cause of cancer deaths in the U.S. In 2020, the American Cancer Society estimated that 148,000 Americans would be diagnosed with colorectal cancer, and another 53,000 would die from it. The U.S. Department of Health & Human Services estimates that approximately 60% of colorectal cancer deaths could be prevented with screening, but one in three Americans who should get tested for colorectal cancer has never been screened.

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.

Media Contact:
Valerie Melucci; pr@solvdhealth.com 

 

SOLVD Health CEO Named Clinical Scientist of the Year by the Association of Clinical Scientists

Prescient Medicine Holdings is Now SOLVD Health

Dec 1, 2020

News Release

Prescient Medicine Holdings is Now SOLVD Health

SOLVD Health’s mission is to prevent disease by making actionable health information accessible to everyone

CARLSBAD, Calif., December 1, 2020 – Prescient Medicine Holdings, Inc., a privately held company focused on developing insights-based health tools, today announced its rebrand to SOLVD Health. The new name and brand reflect the company’s mission to solve some of healthcare’s biggest challenges through preventative health solutions that combine genetics-based patient insights with cutting-edge technologies.

“As we drive toward commercialization of our two breakthrough tests for opioid use disorder and colon cancer, we believe the time is right to evolve our brand to reflect the current and future potential of our innovation platform,” said Keri Donaldson, M.D., Chief Executive Officer of SOLVD Health. “At SOLVD Health, our goal is to create much-needed predictive and actionable health insight tools and make them available to healthcare providers and their patients.”

SOLVD Health will focus on the development and commercialization of its innovative technologies, which utilize machine learning and custom algorithms. These technologies include two groundbreaking tests, which have both been granted Breakthrough Device designations by the U.S. Food and Drug Administration (FDA). One is a genetic test designed to identify people at increased risk for opioid use disorder (OUD) prior to taking oral prescription opioids. The other test analyzes an individual’s microbiome and is designed to detect colorectal cancer and precancerous adenomas.

“At SOLVD Health, we aim to prevent people from becoming patients,” said Dr. Donaldson. “By providing contextualized insights before symptoms occur – a model that we call Patient Intelligence – we can improve patients’ lives while also changing how we think about and conduct healthcare as a society.”

To learn more, visit the new SOLVD Health website at www.solvdhealth.com.

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 on LinkedIn or at www.solvdhealth.com.

Media Contact:
Valerie Melucci; pr@solvdhealth.com 

 

Management Solutions for Opioid Epidemic Are Similar to Management of the COVID-19 Pandemic

Management Solutions for Opioid Epidemic Are Similar to Management of the COVID-19 Pandemic

Sep 21, 2020

News Release

Management Solutions for Opioid Epidemic Are Similar to Management of the COVID-19 Pandemic

Pharmacy Times® interviewed Keri Donaldson, medical director and CEO of Prescient Medicine, about the effects of the COVID-19 pandemic on the opioid epidemic in the United States.

The discussion included how the opioid epidemic in the United States has been affected by the COVID-19 pandemic, how exacerbating mental health problems during the pandemic may lead to increased challenges, whether national efforts to address the opioid epidemic have changed during the pandemic, whether any current efforts to support those affected by the pandemic are also supporting those affected by the opioid epidemic, and why it is necessary to develop effective public health solutions to help manage the opioid addiction crisis.

Donaldson explained that there are many similarities between the COVID-19 pandemic and opioid epidemic in terms of practical solutions.

“The first thing is making sure that you can treat it. Making sure that you have the hospital beds, making sure you have the ventilators—that same analogy [works] in opioid use disorder when we’re making sure people have access to treatment programs and making sure they have safe places to live,” Donaldson said.

He noted that similarly to the COVID-19 pandemic, the next portion of the solution is prevention.

“As we live through this process, you’re seeing people talk about increased testing, increased surveillance, contact tracing, and then as we roll back even further, god willing, we’re going to get to this point where we’re talking about, ‘Okay what about a vaccine?’ And that’s prevention on a public health scale for COVID-19,” Donaldson said. “That same equivalent in opioid use disorder is understanding who’s most at risk and making sure we standardize the process so that each individual is informed—the patient, the provider, the prescriber, and the pharmacist—prior to prescribing so they can objectively understand if a patient has an increased risk prior to filling that first medication.”

Donaldson also discussed how racial disparities have come into play in the opioid epidemic to exacerbate current disparities even further, how obtaining data can clarify the nature of these racial disparities within the opioid epidemic, what pharmacies can do to support the process of addressing the opioid epidemic during COVID-19, what the value of a pharmacist is in supporting communities affected by the opioid epidemic, and what changes are needed in the future for the country’s response to the opioid epidemic.

Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening

Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening

Jun 2, 2020

News Release

Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening

CARLSBAD, Calif., June 2, 2020 – Prescient Metabiomics, a subsidiary of Prescient Medicine Holdings, Inc., announced today a research collaboration with the Harvard Chan Microbiome in Public Health Center (HCMPH Center), a group at the Harvard T.H. Chan School of Public Health dedicated to expanding research on the microbiome to improve public health. The aim of the collaboration is to study microbial biomarkers to identify the presence of precancerous adenomas and carcinomas in the colon. The initial collaboration will investigate prevalent gut microbial biomarkers for colorectal cancer (CRC) by analyzing known, recent CRC cases across populations with which the HCMPH Center works and applying cutting-edge statistical and bioinformatic techniques for microbiome meta-analysis.

“The ongoing research collaboration will further enhance diagnostic screening for colon cancer,” said Keri Donaldson, M.D, chief executive officer at Prescient Medicine. “Offering a non-invasive alternative to colonoscopies that screen for colorectal adenomas and carcinomas could represent a paradigm shift in CRC screening driven by the microbiome. Therefore, research to better understand the microbiome’s role in CRC is needed at this time.”

Curtis Huttenhower, Ph.D., professor of computational biology at Harvard Chan School and co-director of the HCMPH Center, said, “The mission of the HCMPH Center is to improve population health via microbiome science, and there are few chronic disease conditions as well-positioned to benefit from microbiome screening as colorectal cancer. It is one of the most common causes of cancer deaths, but also one of the most preventable cancers if detected early. It’s exciting to embark on this collaboration to advance the latest science and, I hope, eventually deploy our findings to the clinic.”

The past decade has seen a dramatic expansion of research on the human microbiome, including investigation into the role of microbes and microbiota in the gastrointestinal track in the origin and development of CRC. The advancements in this field parallel the preceding decade’s growth in personalized genetic medicine, with the microbiome offering opportunities for both therapeutic and diagnostic biomarker discovery.

According to the American Cancer Society, colorectal cancer is the third leading cause of cancer-related deaths in both men and in women. The U.S. spends approximately $14 billion each year for the diagnosis and treatment of CRC with costs largely due to delayed detection. There is a lack of non-invasive screening tests that can accurately detect precancerous polyps as effectively as a colonoscopy, the current standard of care. Screening recommendations currently suggest a colonoscopy for average-risk patients starting at age 45 every 10 years and earlier for high-risk patients, but approximately one in three patients are not in compliance with these recommendations. Research indicates that early detection of precancerous adenomas and carcinomas could lead to significantly better patient outcomes.

About Metabiomics

Prescient Metabiomics LLC, a privately held company and subsidiary of Prescient Medicine Holdings, Inc., is an early stage molecular diagnostics company developing in-vitro diagnostics that leverage breakthroughs in next-generation DNA sequencing, computational systems biology, and human microbiome sciences. To learn more, visit us at www.metabiomics.com

About SOLVD Health

SOLVD Health (formerly Prescient Medicine) 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.

Media Contact:
Valerie Melucci; pr@solvdhealth.com

Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening

Prescient Medicine and Erasmus MC Partner to Study Opioid Addiction Risk

Dec 10, 2019

News Release

Prescient Medicine and Erasmus MC Partner to Study Opioid Addiction Risk

CARLSBAD, Calif. and ROTTERDAM, Netherlands, December 10, 2019 – Prescient Medicine Holdings, Inc. and the Department of Clinical Chemistry at Erasmus MC (CC-EMC), Rotterdam today announced a partnership for CC-EMC to study opioid addiction risk in The Netherlands. The partnership will center on Prescient Medicine’s novel genetic testing technology designed to objectively assess an individual’s risk of opioid addiction prior to opioid exposure. The clinical research will be conducted with patients in The Netherlands to confirm that the positive results from research completed in the United States are also found in the Dutch health care system.

According to a 2019 study, the overall number of prescription opioid users in The Netherlands has nearly doubled between 2008 and 2017, and the number of opioid-related hospital admissions has tripled.

“We have seen the devastation of opioid addiction in the United States, and we are worried that we are on a similar path in The Netherlands, given the increased rates of opioid use and addiction,” said Professor Ron HN Van Schaik, Ph.D., Erasmus MC. “Evaluating the potential of Prescient Medicine’s diagnostic technology is an important step in future efforts aimed to help address and minimize opioid addiction in The Netherlands. A test like this would give clinicians a tool to proactively determine the risk of opioid addiction for an individual before they are prescribed a medication. This will enable prescribers to make a choice about which drug would serve their patients’ needs best.”

The genetic panel leverages the power of machine learning to assess a patient’s genetic risk of opioid addiction. The test received Breakthrough Device designation from the Food and Drug Administration (FDA) in the United States in February 2018. The work done through this collaboration will be the first time the test has been researched outside of the United States.

“A test like this is valuable to anyone prescribing opioids, not just in the United States,” said Keri Donaldson, M.D., medical director and CEO of Prescient Medicine. “We are excited to expand the use of this test to The Netherlands and potentially help play a part in helping combat the opioid crisis that may be developing in The Netherlands and throughout the world.”

About Department of Clinical Chemistry, Erasmus MC

The Erasmus MC University Medical Center (Erasmus MC), an organization with 17,000 employees in 2019, is committed to a healthy population and excellence in healthcare through research and education. It excels in various research fields, studying fundamental and clinical domains as well as public health and prevention. Research at Erasmus MC is at the heart of society, resulting in innovation, quality improvement and more effectiveness in patient care. The overall research aim of Erasmus MC is to translate bench discoveries to bed-side applications. Bibliometric indicators place Erasmus MC in the top 20 of clinical medicine worldwide. In addition to scientific research, patient care and education are core tasks of Erasmus MC. The complete spectrum of medicine is offered, from disease to health and from individual to public healthcare. Erasmus MC is also the largest medical school in the Netherlands, with ~3,100 medical students and has approximately 250 PhD graduations per year. It offers BSc, MSc and PhD programs to train the next generation of medical practitioners and researchers. Its annual research budget amounts to €139.7 million. The impact of Erasmus MC on the Dutch economy is substantial: in 2012, it contributed €3.8 billion gross value added (GVA) to the Dutch economy and it indirectly supports 40,556 jobs.

The Department of Clinical Chemistry contains the International Federation for Clinical Chemistry (IFCC) Expert Center for Pharmacogenetics, led by Prof Ron HN van Schaik, investigating the translation of genetic information in guiding individualized drug therapy.

About SOLVD Health

SOLVD Health (formerly Prescient Medicine) 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.

Media Contact:
Valerie Melucci; pr@solvdhealth.com