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

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

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

FDA Grants Breakthrough Device Designation to Metabiomics Test for Early Detection of Colon Polyps and Colon Cancer

CARLSBAD, Calif., September 4, 2019 – Prescient Metabiomics, a privately held company and a subsidiary of Prescient Medicine Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted the company’s submission for Breakthrough Device designation to its LifeKit^® Prevent Colorectal Neoplasia Test. This Breakthrough Device designation is the first designation for a non-invasive diagnostic test that is designed to detect pre-cancerous polyps, as well as early-stage carcinomas, with the potential to aid in the interception of carcinogenesis and prevention of colorectal cancer (CRC). In contrast, other non-invasive tests on the market primarily detect full-blown cancer, not precancerous adenomas, and require programs that rely heavily on colonoscopies to achieve colon cancer prevention.

The LifeKit^® Prevent Test deploys patented metagenomics technologies intended to identify microbial DNA and RNA biomarkers that are associated with neoplasia in the lower gastrointestinal tract. Using a non-invasive collection swab, the microbial biomarkers in the stool are analyzed. A positive result indicates the presence of colorectal adenomas or CRC, which should be followed by a diagnostic colonoscopy and polypectomy as appropriate.

A “Breakthrough Device” is an important designation by the FDA because it expedites the review process for medical devices that meet the designation criteria and offers more effective diagnosis of life-threatening diseases and conditions. The Breakthrough Device Program (BDP) offers manufacturers an opportunity to engage with the FDA’s experts to efficiently address topics during the pre-market review phase. Prescient Metabiomics anticipates that FDA support through the BDP will greatly reduce the regulatory timeline required for completing clinical trials and achieving FDA clearance.

“We are excited to deliver LifeKit^® Prevent, a non-invasive diagnostic test that not only will aid in detecting CRC, but also help identify patients at risk for advanced adenomas. By identifying patients most at risk for precancerous lesions, we can stop cancer before it starts and save lives,” says Keri Donaldson, MD, Chief Executive Officer of Prescient Medicine Holdings, Inc. “This important innovation, developed on our robust R&D and machine learning platforms, will allow more targeted and effective treatments earlier. The FDA’s decision confirms the unique aspects of our technology and the potential benefit of our test in addressing the large and increasing population of people at risk of developing CRC.”

About Colon Cancer and LifeKit^® Prevent

Colorectal cancer (CRC) is the third-most common type of cancer and the second leading cause of cancer death in the United States, with over 137,000 new cases and 56,000 deaths annually. The U.S. spends $14 billion each year for the diagnosis and treatment of CRC with costs largely due to delayed detection. While 14 million colonoscopies are performed annually, two-thirds of Americans do not follow screening guidelines and 60 percent of CRC cases are not detected until later stages. Using non-invasive tests to augment colonoscopy has been shown to increase adherence to CRC screening programs. Estimates suggest that broader CRC screening could save 18,800 lives in the U.S. annually.

Previously completed clinical research indicates that LifeKit^® Prevent may be more convenient for patients and healthcare providers to use than currently available CRC diagnostic tests. Based on current findings, LifeKit^® Prevent is highly accurate for detecting colon cancer and, more importantly, for detecting precancerous adenomas that are missed by existing non-invasive tests. A positive result from LifeKit^® Prevent will provide a stronger case to motivate reluctant, high-risk patients to undergo a colonoscopy resulting in the removal of precancerous adenomas to prevent further progression to carcinogenesis and reduce the morbidity and mortality of CRC.

About Metabiomics

Prescient Metabiomics is an early stage molecular diagnostics company that is developing in-vitro diagnostics, screening tests, and health assays that leverage breakthroughs in next-generation DNA sequencing, computational systems biology, and human microbiome sciences. Over the past 15 years, the company’s founders have developed a powerful technology platform for interrogating the human gut microbiome. Prescient Metabiomics is a subsidiary of Prescient Medicine Holdings, Inc. 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