On this bonus episode of "Halteres Presents", host Mickey Urdea is recording live from the first-ever "Diagnostics Zone" at HLTH 2025 in Las Vegas! Among the many old colleagues and new faces we got to meet up with and learn from, we had the opportunity to chat with two very interesting exhibitors: Molecular Testing Labs and OTO Fertility.

From Molecular Testing Labs, Mickey spoke with their Chief Commercial Officer James York about their "tailored solutions for diverse markets" approach, and from OTO Fertility, Mickey spoke with their CEO Caleb Evans about how their wearable device tracks more than fifty biometric markers to help users track their own optimal fertility in harmony with their doctors' care. Please enjoy this bonus episode of "Halteres Presents".

James York is a graduate of East Tennessee State University where he majored in Exercise Physiology and prepared for medical school. Even though his interest was always focused on medicine and science, his first career position was a trader of equities and options on the Southwest Securities Trading Floor. Desiring to enter the healthcare sector and return to his roots, he leveraged his experience from the trading floor to start capitalizing, managing, operating, and making markets in various healthcare companies. James was involved in medical devices, intra-operative neuromonitoring, clinical research, networking, pharmacies, and laboratories. He has had many roles within each company including VP of Sales, President, and CEO – for companies both private and public.

Caleb Evans is a health-tech entrepreneur and the CEO & Founder of OTO Fertility, a breakthrough biometric wearable and AI platform transforming reproductive care. With a background in biochemistry, digital health, and nonprofit leadership, Caleb has scaled organizations across sectors, from EMR software to fertility clinics. His mission with OTO is to apply elite biometric science to family-building, creating a new standard of care for women and couples on their path to parenthood.

This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vitro Diagnostics Product Development, offers a practical, end-to-end look at taking an IVD product from concept to regulatory approval. You’ll learn about product requirements, assay development, instrumentation, risk analysis, and key clinical and regulatory considerations. Learn more about the In Vitro Diagnostics Product Development course ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠.

You can also broaden your skills with their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠.

Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.

Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here.

Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Eric A. Klein, MD, to get his perspective on the value of a molecular cancer signal of origin in guiding targeted diagnostic evaluations based on his real-world experience overseeing GRAIL's clinical development program spanning 9 clinical trials and diverse populations, including those with occupational exposure, and more than 350,000 Galleri tests run. He also opines on what could make multi-cancer early detections tests more widely adopted and how to broaden the definition of clinical utility for reimbursement in MCED testing. Please enjoy this episode of "Halteres Presents".

Eric A. Klein, MD is a Distinguished Scientist at GRAIL. Previously he served as the Andrew C. Novick Distinguished Professor and Chair of the Glickman Urological and Kidney Institute and Lerner College of Medicine of the Cleveland Clinic, where he was also a member of the Department of Cancer Biology of the Cleveland Clinic Lerner Research Institute, the Taussig Cancer Institute, and the Genitourinary Malignancies Program in the Case Comprehensive Cancer Center. Dr. Klein was a Fellow in the Distinguished Careers Institute at Stanford University in 2022 and joined GRAIL in 2023. His recent work has focused on the clinical development of multicancer early detection tests.

This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vitro Diagnostics Product Development, offers a practical, end-to-end look at taking an IVD product from concept to regulatory approval. You’ll learn about product requirements, assay development, instrumentation, risk analysis, and key clinical and regulatory considerations. Learn more about the In Vitro Diagnostics Product Development course ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠.

You can also broaden your skills with their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠.

Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.

Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here.

Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.

On this episode of "Halteres Presents", hosts Mickey Urdea and Rich Thayer are sitting down with Patrick Vaughan, PhD, the Chief Operating Officer of DCN Dx, to discuss the latest advances in lateral flow assays, including innovations in reagents, antibodies, and nucleic acid LFA formats, as well as what it will take for broader adoption of rapid point-of-care testing in rural and underserved settings. Dr. Vaughan also provides valuable industry insight on the regulatory and payment challenges facing developers of new LFA tests. Please enjoy this episode of "Halteres Presents".

Patrick Vaughan has over 20 years of experience in the Biotech field. Patrick has served as the Chief Operating Officer at DCN Diagnostics since September 2015. Prior to this, he was the Vice President of R&D at Trinity Biotech plc from 2003 to 2015. Patrick also founded and served as the Chief Scientific Officer of HiberGen Ltd from 1999 to 2003. Before that, he worked as a Senior Research Scientist at Enterprise Ireland & University College Cork, Ireland (UCC) from 1994 to 2000. Patrick started their career as a Post Doctoral Fellow at Institut Jacque Monod from 1992 to 1994 and as a Post Graduate at the Imperial Cancer Research Fund from 1988 to 1992.

Patrick Vaughan obtained a Bachelor of Science degree in Biochemistry from the University College Cork from 1984 to 1988. Patrick then pursued further education and completed their PhD in Biochemistry at King's College London from 1988 to 1992.

This episode of "Halteres Presents" is brought to you by the UC San Diego Division of Extended Studies, where courses are designed for professionals looking to deepen their expertise in the biotech space. Their core course, In Vitro Diagnostics Product Development, offers a practical, end-to-end look at taking an IVD product from concept to regulatory approval. You’ll learn about product requirements, assay development, instrumentation, risk analysis, and key clinical and regulatory considerations. Learn more about the In Vitro Diagnostics Product Development course ⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠.

You can also broaden your skills with their Precision Medicine and Companion Diagnostics course, which covers biomarker-driven development, CDx/therapeutic co-development, and the expanding role of precision medicine. Learn more about the Precision Medicine and Companion Diagnostics course ⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠.

Use our exclusive discount code HALTERES10 at checkout for 10% off the price of your enrollment.

Advance your diagnostics career with UC San Diego Extended Studies - your next step in biotech starts here.

Learn more about Halteres Associates ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠HERE⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.