Mr. Ero is the CEO of Machaon Diagnostics, a company he founded in 2003. Before founding Machaon Diagnostics, Mr. Ero was VP of the Coagulation Center, Inc. prior to its acquisition by Quest Diagnostics. Mr. Ero is the founder and board chairman of Labs4Free, a charitable organization that provides laboratory services to underserved populations. He holds an MBA from Babson College, certificates in Healthcare Strategy and Finance from Harvard Business School, and a BS in medical technology from Michigan State University. He is a licensed clinical laboratory scientist and a board-certified medical technologist. Mr. Ero has been an inspector for the College of American Pathologists for over 20 years and is a good laboratory practices auditor and an FDA and EMA regulatory affairs consultant.
Can you share the journey that led Machaon Diagnostics to focus on rare disease testing?
Machaon Diagnostics is a reference laboratory and specialized CRO founded in 2003. Fun Fact: I was only 29 years old when I founded Machaon Diagnostics; I was already a CAP inspector and a California-licensed clinical lab scientist at a specialized coagulation laboratory. Building on that expertise, we grew to develop an extensive menu of tests that together provide 360-degree insight into diseases such as hemophilia. Then we expanded into related diseases within hematology such as atypical hemolytic uremic syndrome (aHUS) and from there nephrology. Our expertise in coagulation, platelet, complement, hyperinflammation, and genetics is now valued by clients sponsoring trials in a variety of rare diseases: from immunology and cardiovascular to ophthalmology and women’s health. Also, 9 out of the 10 premier medical centers in the US now use our clinical lab services.
What are the major hurdles in conducting successful trials for a rare disease therapeutic?
One of the bottlenecks for rare disease clinical trials is limited access to rare disease subject populations or rare disease samples because of poor characterization of the diseases. Often these challenges result in delayed success or outright failure of rare disease trials. Thus, less than 5% of the more than 7,000 rare diseases believed to affect humans currently have an effective treatment.
Often, pharmaceutical and biotechnology clients seek our help in identifying high-volume clinical sites with pools of patients with a targeted disease, or to source rare clinical samples. Machaon Diagnostics is uniquely situated to define a clear patient journey map for rare disease populations — specifically in coagulation, platelet, complement-linked, chronic kidney, and rare genetic diseases. Our solutions include: disease fingerprinting drawing on the decades of experience of our MD medical directors; custom algorithm design combining the right diagnostic codes with medical records; sample finding using our lab and clinical expertise plus physician relationships; and site identification via finding aggregator physicians Thus, we have partnered with 8 of the 10 largest pharmaceutical and CRO firms to achieve their study objectives, timelines and budget goals, with a high volume of eligible patients.
For the many patients who would forgo testing due to cost, we also assemble a variety of organizations that act as third-party payers, which constitute sponsored testing programs.
In what ways do insights from lab experts shape and refine the design of rare disease studies?
Eighty percent of all medical decisions rely on laboratory results. The laboratory perspective on precision medicine is vital to the development of innovative treatments and revolutionary devices. A laboratory that serves both hospitals and clinics, as well as drug and device developers, is particularly valuable. Rare disease therapeutics companies began to seek us out to support trials, so we expanded our capabilities in 2016 to launch a rare disease CRO within Machaon. Studies leverage our nimble, accessible team’s diverse academic and industry backgrounds, PhD-level curiosity, and desire to design progressively better solutions.
What features distinguish Machaon Diagnostics’ testing solutions in the rare disease market?
Operational excellence is a key differentiator for Machaon. For example:
- next-generation sequencing (NGS) results are reported within 48 hours of arriving at our facility.
- 99.9% of our ADAMTS13 activity test requests are reported within 24 hours of arrival, seven days a week.
- complement activation (sC5b-9), when ordered STAT, is reported on average within only 6.4 hours.
Supporting weekend flexibility reflects our understanding that the timing of clinically adverse events is generally unpredictable. We optimize not only when sites and sponsors get results but also how (e.g. by establishing server interfaces, SMS alerts, and other options as needed).
Additionally, as a lab and CRO, Machaon is uniquely positioned to find subjects, clinical sites, and rare samples present in the healthcare system, as mentioned above.
When is speed critical in rare disease diagnosis and treatment?
Short turnaround times and clinical utility/value are tightly linked. Our disease indications often demand rapid services to prevent loss of life or organ function. As Machaon is driven by the mission to “save more lives with lab tests”, we choose to build workflows, infrastructure, and culture to enable the fastest turnaround times in the industry. For lab services to maintain both speed and high quality, we rely on four pillars: 1) reagent selection that maximizes clinical sensitivity and specificity; 2) test performance that is accurate and reliable, as assured by CAP/CLIA accreditation and New York licensure, requiring rigorous assay validations and regular performance assessments; 3) clinical interpretation that is meaningful, aided by direct consultation with our medical directors; and 4) a clinically relevant turnaround time.
What are some developments in rare disease diagnostics that you’re currently excited about?
As we know, the diagnostic odyssey of a rare disease patient often extends for many years. Fast and high-quality diagnostic solutions – for inclusion in trials, safety/immunogenicity testing, and companion diagnostics – allow us to partner on cutting-edge clinical trials like cell and gene therapy. We invite you to explore our menu and contact us about how we can help you achieve your goals. Learn more about Machaon by going to www.machaondiagnostics.com
