GreyBird Ventures has an exclusive investment focus on precision diagnostics.  We have reviewed over 1500 diagnostic start-up firms investing in fewer than one for every 150 that we review.  We will present an overview of this experience, our thoughts about how we (and others) make diagnostic investment decisions, some advice for firms seeking funding, and present a few “Grand Challenges” in diagnostics that would automatically warrant careful consideration.

Diagnostics have never been more important or visible on the world stage as they are today in the midst of the COVID-19 global pandemic. Mara will speak about how COVID diagnostics have been developed, and how they are and should be used to fight the virus through timely diagnosis and monitoring – as well as introduce you to the largest database of COVID tests worldwide, TestingCommons.com, which she created with the team at Arizona State University and The Rockefeller Foundation. 

The pandemic highlighted historical gaps in diagnostics infrastructure. Significant private and government resources have been activated, and Qorvo Biotechnologies has developed Point-of-Care diagnostics capability based on orthogonal technology to address todays testing needs. This presentation focuses on product technological innovation, the government partnerships that have established volume market access, and how this positions the platform for future testing success beyond COVID-19.

Often, assay validation requires additional mutated or wild type samples to supplement reserved tissue from trial subjects. In response, Precision has embarked on a large-scale initiative to sequence curated samples from our massive tissue archive, Project P.O.S.I. – the Precision Oncology Sequencing Initiative. In this talk we will discuss how CDx development programs can be accelerated by overcoming the barriers of exhausted or insufficient clinical trial material with pre-characterized disease-specific specimens.  

Technology has changed the way we diagnose and treat illness. A doctor used to diagnose using a stick and small flashlight. Doctors had an incredibly small amount of information. Today they have way too much. Diagnostics has evolved into Tech-nostics. Our understanding of genetics, epigenetics, microbiome, epibiome, proteome, communicome and virome, along with the diseases they spawn, has skyrocketed with new ways of collecting and analyzing data. We are innovating at the intersection of science, chemistry and technology. This tectonic shift is forever changing the way we think about, and approach, the science of medicine.

MolDX is a program operated by PalmettoGBA to set molecular diagnostics policy and payor controls in 28 states. This talk will cover the scope and philosophy of the program, as well as provide instruction to providers on how to approach payors seeking coverage and reimbursement.

Medicare remains one of the largest payors for molecular diagnostics, with over $1.5B in payments in CY2019. Both national and local decisions are coming out at a rapid pace, and the Medicare agency is so large it impacts both investment and development. Recent decisions reshape germline testing, cancer tissue testing, and preventive testing. Understand what areas are "pre-covered" and how your test can qualify. We'll also discuss implications for the 40% of patients in Medicare Advantage plans.

Only one hurdle remains: Commercial payer coverage. But the door is locked (and dead-bolted). Getting through seems impossible—but it’s not. All you need are the right keys. Fortunately, you can make them yourself. But they’ll only work if you adhere to certain specifications. In this session, we’ll talk about those specifications, how to make the keys you need, and what to expect on the other side of the door.

Traditional market access – with a primary focus on coverage, coding, and reimbursement – is evolving. The COVID-19 pandemic has accelerated these changes and has created new challenges and opportunities. Innovative approaches, focusing on partnership and high-quality evidence generation, can help accelerate access.

Market access is a business of relationships. It is a business driven by market knowledge and how that market knowledge can be translated and communicated to industry stakeholders. The global pandemic has shifted the way we do business. This session will focus on redefining market access to align with our new realities.

COVID-19 significantly disrupted the diagnostics industry as manufacturers raced to develop and manufacture millions of SARS-CoV-2 tests, testing laboratories struggled to source enough SARS-CoV-2 tests, governments and payers spent tens of billions of dollars on testing, investors entered to capitalize on this windfall and clinicians managed many of their patients remotely. We will examine this unprecedented moment in the history of diagnostics and how our world has changed.

Sherlock Biosciences is engineering biology to develop products that enable people to access answers and have more control over their health decisions. In this talk, we will discuss how Sherlock is harnessing proprietary CRISPR and synthetic biology tools, together with deep learning, to solve a range of diagnostic challenges in environments ranging from clinical labs to low resources areas, including the home. 

Autonomous AI allows for immediate point-of-care diagnosis which can increase access, address health disparities, and lower costs. But to address health equity with AI it’s important to start with an ethical framework then address liability, standard of care, (FDA) regulation, CPT coding, reimbursement, and HEDIS/MIPS quality measurements. Autonomous AI can have a positive impact in healthcare, but it must be done the right way.

Wearable sensors have received a major recent attention owing to their considerable promise for monitoring the wearer’s health and wellness. The medical interest for wearable systems arises from the need for monitoring patients over long periods of time. These devices have the potential to continuously collect vital health information from a person’s body and provide this information to them or their healthcare provider in a timely fashion. Such sensing platforms provide new avenues to continuously and non-invasively monitor individuals and can thus tender crucial real-time information regarding a wearer’s health. This presentation will discuss recent developments in the field of wearable electrochemical sensors integrated directly on the epidermis, under the skin, or within the mouth for various non-invasive and minimally invasive biomedical monitoring applications. Particular attention will be given to non-invasive monitoring of metabolites and electrolytes using flexible electrochemical sensors, to multiplexed microneedle sensor arrays, along with related materials, energy, and integration considerations. The preparation and characterization of such wearable electrochemical sensors will be described, along with their current status and future prospects and challenges.