Over the course of the last several years, Exact Sciences has made 3 crucial moves to accelerate patient impact and drive business growth: (1) Entered into a commercial partnership with Pfizer to drive patient and physician awareness of Cologuard and fundamentally increase adoption; (2) Forged a partnership with Epic to improve order management of Cologuard and eventually allow seamless ordering of the product within EHR systems; (3) Acquired Genomic Health to expand into entirely new areas of cancer patient care. Each of these actions positions Exact Sciences to serve an ever-greater number of patients on all phases of their journey.

As a national medical practice, our goal at Genome Medical is to facilitate genomic testing and downstream care for those whose clinical findings, family history, or interest in finding out their risk of actionable genetic disease indicates a need for genetic care. As a driver of commercial strategies, we establish key partnerships – with testing laboratories, employers, health systems, and treatment centers – that optimize access across a range of value-based products in both primary care and specialty care pathways.

Changes in international standards and regulations have created challenges and roadblocks to the commercialization of diagnostic devices. The choice of a contract manufacturing (CM) partner with the expertise to provide guidance and manufacturing capabilities is one strategy diagnostics companies can use to mitigate risk.  A well-chosen CM partner can accelerate the commercialization process by anticipating potential roadblocks.  In this session, we will discuss best practices and key considerations for vetting contract manufacturing partners.

• Academic versus community hospitals’ requirements for diagnostics
• Resources, processes, and outcomes
• Reimbursement and regulations

Launching innovative diagnostics tests has never been so challenging. You did all the right things – followed the voice of your customers, developed the product to meet performance requirements, conducted clinical validations, and obtained regulatory approvals. Yet, this is not sufficient to be successful in the marketplace. In fact, these are the prerequisites. This talk will cover several factors that drive successful commercialization and market access efforts required to make your product launch a success.

Drawing from two decades of experience working in oncology, Foundation Medicine’s Chief Commercial Officer, Tesh Khullar, will discuss the importance of a patient-centered commercialization strategy. He will focus specifically on his team’s efforts to expand access to precision medicine for cancer patients through the company’s portfolio of comprehensive genomic profiling assays.

This presentation maps the path and discusses Guardant’s approach for entering the companion diagnostic test market.

eRapid is electrical sensor technology, enabling the detection of small chemicals and large biomolecules in complex fluid samples, including blood, saliva, and urine without requiring sample preparation. This proprietary sensor technology offers a versatile, multiplexed, cost-effective, robust, manufacturable, and scalable approach adaptable to a variety of testing strategies addressing high-value challenges in multiple fields, ranging from home healthcare to industrial, environmental, and food applications.  

I will discuss the federal resources for early-stage companies that fall into the research portfolios of biosensors, platform technologies, and mHealth programs at NIH. NIBIB Point-of-Care Technologies Research Network will be explained, consisting of three centers charged with developing point-of-care diagnostic technologies through collaborative efforts that merge scientific and technological capabilities with clinical need.