From Approval to Access: ASMM and Geneoscopy on Fixing the Gaps in Cancer Screening Adoption

Matthew Fleisher J.D., M.P.H. and Matt Sargent , Geneoscopy

Too often, new cancer screening tests clear regulatory hurdles—only to hit roadblocks when it comes to real-world access. At Geneoscopy, we believe innovative tests like ColoSense can help close the significant gap in colorectal cancer screening, but only if policies and quality measures keep pace with scientific advancements. That’s why we joined the Alliance for Screening Measurement Modernization (ASMM).

Today, we explored how this work is paving the way for broader access to lifesaving diagnostics with Matthew Fleisher J.D., M.P.H. , Founder and Managing Director of Rubrum Advising, and Matt Sargent ,MS, MBA, CCO of Geneoscopy.

We’d love to hear your thoughts with a comment or question below.

1) What was the driving force behind the formation of the Alliance for Screening Measurement Modernization (ASMM)?

Matthew Fleisher: When Lee [Fleisher] and I founded Rubrum Advising, one of our goals was to focus on policy areas where thoughtful, practical solutions could meaningfully advance patient care. A key reality is that provider behavior and health insurer policies heavily influence patient outcomes. Quality measures are intended to shape behavior toward delivering higher quality care by transparently providing patients and providers with best practices and to incentivize higher screening compliance. However, some screening measures do not keep pace with the inclusion of best practice for the most current and effective diagnostic tests. When this happens, measures can unintentionally discourage the use of lifesaving technologies that patients or providers might choose to use, ultimately limiting early and accurate disease detection. As we reviewed how screening measures are updated, we discovered that absent a USPSTF recommendation, there is no consistent, transparent, and streamlined framework that empowers measure stewards to update their measures and incorporate the latest clinical evidence. To address this gap, we launched ASMM in conjunction with a broad coalition of stakeholders. Together, we aim to develop a methodology-driven framework that ensures updates to screening measures are guided by the most appropriate evidence review bodies. The end goal is simple but critical: ensuring patients have timely access to all high-quality screening tools, aligned with their preferences for screening modality.

2) Why did Geneoscopy choose to become a founding member?

Matt Sargent: The goals of the ASMM directly align with Geneoscopy’s mission: to accelerate patient access to innovative diagnostics. Geneoscopy is a new entrant to the large, although still underserved, colorectal cancer (CRC) screening market. A range of screening options are currently available, from the current gold-standard colonoscopy to noninvasive tests like the fecal immunochemical test (FIT) and other established at-home stool tests, alongside newly introduced blood-based solutions.

Geneoscopy’s nimble, out-of-the-box strategy and entrepreneurial thought process have enabled the company to successfully enter and navigate this challenging market with a fraction of the capital of other participants. Sometimes the system works in your favor, but when it works against you, a more thoughtful and proactive approach is required. Becoming a founding member of the ASMM Industry Council is just another example of how Geneoscopy continues to tackle entrenched industry challenges with proactive, future-focused solutions.

From an outcomes perspective, it is crucial that Geneoscopy works to help shape policies, ensuring that advancements like ColoSense reach patients without delay. A laboratory could offer the most clinically relevant and effective diagnostic test ever invented, but bringing that test to market is extremely difficult in today’s US Healthcare system. Regardless of clinical impact, a test won’t be used if it lacks reimbursement, increases patient out-of-pocket costs, or isn’t included in quality measures tied to value-based care or ratings of providers or health plans.

Fault does not lie with the payer or the ordering provider. Unfortunately, it is an unintended consequence of a system set up with the best intentions to make quality patient care available, but which has, instead, become a roadblock to increasing choice and access to new products.

3) From your perspective, why is industry participation essential in efforts like ASMM?

Matthew Fleisher: Transparency is fundamental to building any standardized framework. ASMM was founded on the principle of creating a thoughtful, open process for modernizing screening measures to reflect the best available options. Industry brings an important perspective to that effort. Manufacturers and developers have invaluable clarity into how patients actually use new technologies, and just as importantly, the barriers patients face in accessing and adopting them. 

4) One of ASMM’s goals is to accelerate access to innovative diagnostics. How does that mission align with what you’re seeing in the colorectal cancer space?

Matt Sargent: Colorectal cancer (CRC) incidence is rising sharply among younger populations, making it the fastest-growing cancer in Americans under 50. Despite the availability of multiple screening options, a critical gap persists: 44 million people aged 45-75 remain unscreened for CRC. This isn't simply a matter of limited choices. The gap has widened due to insufficient capacity for invasive procedures, such as colonoscopies, and ongoing barriers to their adoption. Many patients are hesitant to undergo a colonoscopy unless they’re considered high-risk, and follow-through rates for noninvasive tests remain low. 

To effectively address this and ensure CRC remains a manageable disease with positive outcomes, we need faster access to new noninvasive screening options. This will only be accomplished if we work together to change the policies that currently slow or actively block new products from reaching patients.

The ASMM will provide quality measure developers with a framework that enables them to address delays in updating guidelines. This is a crucial step toward driving early detection and improving outcomes for patients most in need.

5) What does the ColoSense story tell us about the potential public health impact when national policy evolves to reflect the pace of change in technology development?

Matt Sargent: The ColoSense story, from its FDA approval to NCCN guideline inclusion, demonstrates that when policies evolve to recognize improved processes and solutions, including patient acceptance, the potential for public health impact is significantly accelerated. 

This is why the ASMM is groundbreaking for the entire industry. Under the current system, every diagnostic laboratory will face the same obstacles and challenges that we have. Our goal is to improve and accelerate this process. We are not participating just for personal gain, but for all patients to have access to better, more effective diagnostic tests that can prevent or detect cancer and save lives.

When there is a streamlined pathway from scientific advancement to adoption, supported by initiatives like ASMM, it leads to increased screening rates, improved patient outcomes, and a greater chance of preventing late-stage disease.