SOLVD Health
Prescient Medicine Holdings is Now SOLVD Health

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, on Twitter, or at www.solvdhealth.com.

Media Contact:
Janelle Drumwright; pr@solvdhealth.com 

 

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:
Janelle Drumwright; 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:
Janelle Drumwright; pr@solvdhealth.com 

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

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

Sep 4, 2019

News Release

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:
Janelle Drumwright; pr@solvdhealth.com

 

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

Prescient Medicine Holdings Inc. Acquires AutoGenomics Inc.

Apr 23, 2019

News Release

Prescient Medicine Holdings Inc. Acquires AutoGenomics Inc.

HUMMELSTOWN, Penn., April 23, 2019 – Prescient Medicine Holdings Inc. announced today it has acquired AutoGenomics Inc., a privately-held U.S. molecular diagnostics company, which has developed and commercialized the INFINITI® platform – a 510(k) exempt, automated, microarray-based multiplexing diagnostic system with applications in personalized medicine, pain management, cardiovascular health, mental health, women’s health, oncology, infectious diseases and genetic disorders.

The acquisition of AutoGenomics will enable Prescient Medicine to advance the development and commercialization of the INFINITI® Neural Response Panel, a novel diagnostic test for the identification of patients who may be at risk for opioid use disorder (OUD), leveraging the work of both companies completed through a collaboration initiated in 2017.

The INFINITI® Neural Response Panel identifies genetic mutations involved in the brain’s reward pathways associated with increased risk of opioid use disorder. The U.S. Food and Drug Administration (FDA) has granted the INFINITI® Neural Response Panel a Breakthrough Device designation. Prescient Medicine and AutoGenomics intend to pursue a de Novo premarket submission. Prescient Medicine will market the INFINITI® Neural Response Panel as LifeKit® Predict to provide physicians with objective information to help assess the risk of developing an addiction to oral opioids.

According to the CDC, the total economic burden of prescription opioid misuse in the U.S. is more than $78 billion annually. Approximately 68% of the more than 70,200 drug overdose deaths in 2017 involved an opioid, and 36% of those deaths involved prescription opioids. On average, 130 Americans die every day from an opioid overdose.

In addition to the INFINITI® Neural Response Panel, the AutoGenomics acquisition provides Prescient Medicine with access to the entire INFINITI® product portfolio including the suite of INFINITI® analyzers and a menu of over 65 molecular diagnostic tests across critical disease indications, which will complement Prescient Medicine’s LifeKit® product line of diagnostics.

“Acquiring AutoGenomics provides a robust platform which will accelerate our efforts and advance our delivery of novel diagnostic solutions designed to address the most pressing issues in healthcare, including the opioid crisis.”, said Keri Donaldson, MD, Chief Executive Officer of Prescient Medicine. “The combination of the AutoGenomics platform and Prescient Medicine’s existing toxicology and pharmacogenomic solutions allows us to immediately deliver high-value, enhanced services to both firms’ existing clients and the market.”

About AutoGenomics

AutoGenomics Inc., a privately held company based in Carlsbad, CA, developed the first automated, microarray based multiplexing diagnostic platform that can be used to assess disease signatures with novel genomic and proteomic markers. AutoGenomics’ molecular diagnostics proprietary technology platform is in use globally in clinical reference laboratories, contract research organizations (CROs), specialty clinics and hospital laboratories. The platform consists of a family of INFINITI® analyzers including the INFINITI® PLUS, a prepared sample to answer system, and the INFINITI® High Throughput System, which has the capability of producing over 6,000 patient results per day. The platform also includes five U.S. FDA cleared tests and a menu of over 65 molecular diagnostic tests for potential application in the areas of personalized medicine (pain management, cardiovascular health assessment and mental health therapy), women’s health, oncology, infectious diseases and genetic disorders. With the discovery of genes and their link to various disease states, the platform has the versatility to revolutionize the way patients are diagnosed, monitored and managed, leading to the era of precision medicine. www.autogenomics.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:
Janelle Drumwright; pr@solvdhealth.com