Dave Vigerust: Transforming Healthcare Through Personalized Medicine and Innovation 

The healthcare and medical diagnostics industry is undergoing a transformative shift driven by advancements in personalized medicine, non-invasive testing, and precision technologies. The focus has moved beyond traditional treatments, with a growing importance on tailoring medical approaches to individual needs. This shift aims to improve patient outcomes by offering more targeted and effective solutions. Companies in this sector are also expanding their efforts to make diagnostic tools more accessible and affordable, addressing long-standing barriers such as patient access to healthcare and the limitations of conventional medical practices. Innovations in biospecimen collection, diagnostics, and the integration of telemedicine are further contributing to these changes, providing patients with new opportunities to take charge of their health.

Dave Vigerust, Chief Scientific Officer, has dedicated his career to pushing the boundaries of medical science, particularly in the fields of personalized medicine and diagnostic development. His work spans a variety of areas, from advancing non-invasive testing solutions to exploring the links between oral health and chronic systemic diseases. With a keen understanding of both scientific research and business strategy, Dave has been instrumental in bringing scientific innovations to the forefront of patient care. His efforts are focused on delivering practical applications of cutting-edge research that directly impact patient health, making a difference in both the lives of individuals and the broader healthcare system.

SpectrumSolutions, alongside Dave’s other associated companies, Strategic Biosciences and Cancer Diagnostics of America, have emerged as key players in the development of innovative diagnostic solutions. The work of each of these companies includes the creation of advanced diagnostic assays and patient-tailored therapies to set new standards in the medical field. Through integrated approaches, Spectrum Solutions, Strategic Biosciences and Cancer Diagnostics of America continue to shape the future of healthcare by providing groundbreaking tools that enable more effective, personalized treatment plans for a wide range of conditions.

Advancing Personalized Medicine for Improved Patient Outcomes

Throughout his career, Dave has been committed to advancing healthcare solutions with a direct and positive impact on patients. His work has spanned various companies focused on improving access to testing and care, with a core objective of translating medical research into products and services that benefit patients.

In his role as a university professor and academic, Dave concentrated on projects that had the potential to bring tangible benefits to patients. He believes that one of the most effective ways to achieve this is by combining academic research with a business perspective, moving innovations from the laboratory into practical applications. Over the years, Dave has developed a range of diagnostic assays for conditions including diabetes, cardiovascular disease, infectious diseases, and cancer. These assays have always been driven by specific needs within the healthcare community.

A pivotal moment in his career came when he recognized the shortcomings of traditional medical approaches, particularly in the treatment of diseases such as heart disease, diabetes, and cancer. Dave observed that patients were often treated according to a one-size-fits-all approach, without consideration for the individuality of each person. He believes that medicine should be tailored to the unique characteristics and needs of the individual, as not every patient responds the same way to a particular treatment or medication.

As CSO of Cancer Diagnostics of America (CDA), Dave is spearheading the development of a personalized approach to cancer treatment. CDA's innovative approach involves taking a small sample of a patient's cancer and analyzing it in the laboratory to determine the most effective drugs and therapies based on the individual's unique biology. This contrasts with the conventional method, where patients are placed on a treatment protocol based on the general characteristics of their cancer, which often yields suboptimal results. In fact, current treatment protocols are effective in only a small portion of cases, and for those patients who do not respond, the prior treatment can complicate subsequent therapeutic options.

With CDA's approach, the treatment plan is tailored specifically to the patient's cancer, maximizing the likelihood of a successful outcome. By identifying the most effective drugs for each individual, CDA aims to improve treatment efficacy and increase the chances of success in cancer care. This personalized approach represents a significant advancement in cancer treatment and has the potential to transform the way cancer is managed.

Dave also recognizes that successful scientific innovations must be paired with business acumen to ensure their effective deployment within the medical and advocacy communities. By advancing these innovations through successful business models, he believes that further research and development can continue to disrupt the current medical model, leading to improved patient outcomes and more personalized care in the future.

Innovative Diagnostics for Systemic Health Risks

Dave has been instrumental in advancing non-invasive biospecimen collection methods for medical, dental, and wellness applications, which are key to improving public health. Many individuals face barriers to accessing diagnostic services or experience fear of blood collection. Dave is leading efforts in a shift toward remote health monitoring, where saliva and other biofluid samples can be collected easily and painlessly. These samples can be preserved for shipping at room temperature without compromising result accuracy.

For years, telemedicine, teledentistry, and consumer-directed testing have provided patients with insights into their health and wellness. These platforms improve access, education, and outcomes for patients seeking to manage potential chronic health conditions. Saliva, in particular, is an effective sample medium for monitoring various health markers. Spectrum Solutions, under Dave's leadership, is at the forefront of this innovation with a vertically integrated system that includes a proprietary collection device and a stabilizing solution designed to preserve samples during transit. The company also has a diagnostic development division, which enables the creation of in-house clinical diagnostic assays. In addition, Spectrum Solutions operates a CLIA and CAP-accredited laboratory to conduct these assays and a compounding pharmacy that supplies therapeutics tailored to improve patients' health based on diagnostic results.

Spectrum Solutions stands out as the only company specializing in salivary collection with such a comprehensive range of vertical integration. The company’s technical and logistical capabilities are extensive. During the COVID-19 pandemic, Spectrum Solutions was the first to receive FDA Emergency Use Authorization (EUA) for using saliva to detect COVID-19. Since then, the company has expanded its portfolio, developing additional collection devices for hormones, proteins, inflammation, and infectious diseases.

One of the major projects Dave has championed is SimplyPerio, a product he has developed over the past 12 years. This product provides critical insights into how oral health impacts systemic health. Decades of research have shown that pathogenic organisms in the mouth can contribute to gum disease, which in turn can lead to serious conditions such as heart disease, stroke, neurodegenerative diseases, metabolic disorders, joint diseases, and pregnancy risk. SimplyPerio enables physicians and dentists to detect gum disease and assess the risk of related systemic health issues. Dave and his colleagues have published studies identifying the specific organisms responsible for gum disease and how these microorganisms contribute to heart attack and stroke risk. These efforts are making a significant impact on patient care by helping to identify health risks early.

With nearly 50% of the population over the age of 30 potentially suffering from undiagnosed gum disease, Dave’s work has far-reaching implications. Gum disease has been linked to numerous systemic conditions, including heart disease, stroke, diabetes, liver disease, and cancer. The global impact of this research is profound. Dave is deeply passionate about helping patients live healthier lives through innovative testing solutions. His work has the potential to impact millions of individuals worldwide, particularly those at risk for chronic conditions. As heart disease remains the leading cause of death in the United States, Dave is driven by the opportunity to reduce this risk and improve the health outcomes of countless patients.

Overcoming Healthcare Barriers to Innovation and Patient Access

One of the major obstacles in healthcare today is the current medical and insurance model, which often creates conflicts that impede the delivery of better solutions for patients. The insurance system frequently does not prioritize improved patient outcomes, making it difficult to gather the necessary data to convince stakeholders in the medical community. A clear example of this challenge is pharmacogenomics (PGX), a technology that allows laboratories to analyze a saliva or blood sample to determine how well a patient can metabolize medications by examining specific genes in the liver.

Despite being around for nearly 50 years, PGX is underutilized within the medical community when it comes to gaining insights into the metabolism of currently marketed drugs. PGX has been shown to be clinically beneficial for patients with conditions such as heart disease, diabetes, cancer, anxiety, and depression. However, insurance companies often do not cover the cost of PGX testing despite substantial evidence of its clinical utility and cost-saving potential. This results in patients frequently having to pay out of pocket for the test, even though it could significantly improve patient outcomes by ensuring the correct drug therapies are prescribed.

In addition to issues with insurance coverage, the regulatory environment has become more challenging due to initiatives from the FDA and other organizations aimed at tightening healthcare regulations. These increased regulatory requirements can delay the launch of new products designed to benefit patients, particularly for small companies that lack the financial resources to navigate the complex and time-consuming regulatory process. While these regulations are often framed as necessary for public safety, they can also act as a barrier to innovation, limiting improvements in patient care.

To overcome these obstacles, the strategy is to remain resilient and build a team of subject matter experts across various disciplines. By working collaboratively, the team can effectively address the challenges that hinder innovation and delay the market introduction of new products.

Prioritizing Patient Needs and Scientific Integrity Over Profit

The teams at Spectrum Solutions, Strategic Biosciences, and Cancer Diagnostics of America prioritize scientific integrity and patient needs in all their efforts. At times, the pursuit of the best product can conflict with commercial objectives. However, the company's approach is to prioritize the creation of the highest quality products and services. This focus may result in lower profits for some products, but the primary goal is to serve patients. By staying committed to providing the best solutions for clinicians and patients, long-term business success will follow.

Linking Oral Health to Chronic Disease Risk

Dave’s work has made significant contributions to understanding the central role of inflammation in most, if not all, chronic diseases. In particular, his research highlights the widespread issues of gum and oral health, which affect millions globally. The oral cavity serves as a gateway to the body, and what enters through the mouth has a profound impact on overall health, wellness, and longevity. Dave has been instrumental in educating both the dental and medical communities about the far-reaching effects of gum disease.

His current and past research establishes a clear connection between certain bacterial, viral, and fungal infections in the oral cavity and the onset and progression of several chronic conditions. Studies indicate that these infections can contribute to heart attacks, Parkinson’s disease, and Alzheimer’s disease and can worsen the effects of diabetes and other metabolic disorders. One of Dave’s most notable achievements is the development of the SimplyPerio product, which offers both patients and clinicians a comprehensive understanding of oral health. This product is considered one of the best available for providing insights into oral health. Through continued education and testing, there is potential to reduce the prevalence of heart disease, diabetes, and brain-related illnesses, particularly as people age. Dave believes that longevity and sustained health begin in the mouth, and his work is at the forefront of identifying biomarkers that can help mitigate inflammation and other systemic issues linked to poor oral health.

Additionally, Dave developed a fast and cost-effective technique for genetically determining a marker known as haptoglobin, which plays a significant role in chronic diseases. The marker’s three forms vary among individuals, with the highest-risk variant found in approximately 37% of the U.S. population. This variant produces a precursor protein called zonulin, which is associated with conditions such as celiac disease and leaky gut syndrome. Zonulin can cause allergens and other substances to pass from the gut into the bloodstream, triggering sensitivities, including gluten intolerance. This variant also significantly increases the risk of heart attack and stroke, particularly in patients with type 2 diabetes, a condition affecting an estimated 80-100 million people in the U.S. By identifying which haptoglobin variant a patient carries, healthcare providers can assess the risks of leaky gut, leaky gums, and leaky brain. Additionally, this information can help determine a person’s cardiovascular risk, potential diabetes complications, and the risk of cancer development. Dave’s MyHap2 and Hap2 tests offer the potential to enhance screening and diagnostics, ultimately improving the health of millions of people in the U.S. and globally.

Advancing Precision Medicine for Broader Access and Self-Advocacy

Dave's vision is for precision medicine to become a standard tool in healthcare, making it more accessible and allowing individuals to proactively utilize precision tools for their health and wellness. Achieving this vision requires reducing costs and increasing clinicians' comfort with technologies like precision genetics, proteomics, and metabolomics, which provide valuable insights into patient health.

Currently, precision medicine is not widely integrated into the curricula of medical, dental, and chiropractic schools, leading to a lack of familiarity with these concepts among clinicians. As a result, training on the benefits, utility, and application of precision medicine takes longer. Dave believes that in the near future, individuals will be empowered to advocate for their own health, and his work will play a key role in providing innovative and disruptive products that will benefit the public.

Trusting Your Path and Embracing Failure as Growth

Dave’s best advice is to trust one’s internal compass. As individuals pursue their career goals, they will receive advice from various sources—some of which will offer helpful guidance, while others may create doubt and hinder progress. It is crucial to evaluate all advice carefully, trust one’s instincts, and choose a personal path. Competition in science, academia, and business is intense, and often, the only true direction is the one a person believes is right.

At times, ideas may be dismissed as unrealistic or unachievable, but Dave advises not to be discouraged. Instead, individuals should pursue their ideas, dreams, and goals regardless of the setbacks. Both science and business share a common element: failure. It is a natural part of the journey but not an insurmountable one. Every worthwhile endeavour carries some risk of failure, and while some paths may lead to success, others may not. When faced with failure, it is important to persevere, as each experience offers valuable lessons that contribute to growth in both science and business.

Communicating Complex Science to Diverse Audiences

The TEDx talk provided Dave with the opportunity to communicate the values of precision medicine while learning to address diverse audiences in a clear and accessible way. Scientific publications are typically technical and filled with jargon, making it rare for scientists to speak to a broad audience that includes experts, laypeople, and the general public. Most scientists have limited public speaking experience, and the TEDx talk was instrumental in helping Dave improve his ability to convey complex topics in a straightforward, plainspoken manner.

Improving Patient Outcomes Through Innovation and Education