Liquid Biopsy – What’s real and what’s hype?

Diagnostics Manufacturers and Labs: Improve test quality through new avenues and focus on conveying clinical utility at key treatment decision-points outside of therapy selection

By exploring alternative technologies that test for new targets such as RNA and proteins (instead of ctDNA, which has been a primary focus of the market), Dx manufacturers and labs may be able to improve test accuracy, an issue that has plagued this technology since its discovery many decades ago.

Additionally, market value has largely been concentrated in treatment selection, where tissue is often preferred if available – improving test quality to expand application across the diagnostic continuum, particularly for monitoring, early screening and risk stratification, will be particularly beneficial in unlocking market potential.

Tumor-agnostic testing for therapy selection seems to be an idealistic ambition at this time, but as advances in tumor agnostic therapies continue to drive innovation in the biopharma industry, with updated approval processes at both the FDA and EMA that support this innovation, Dx companies need to follow suit and pave the way with tumor agnostic testing – better liquid biopsy tests would lend itself well to this purpose.

While there are a few large liquid biopsy panels for therapy selection on the market, companies that offer smaller, more targeted panels are carving out a niche for themselves and getting adopted by clinicians. This also addresses the reimbursement challenges that are associated with testing everything under the sun as payors establish high standards for RWE on overall cost effectiveness.

While specialty labs (e.g., Grail, FoundationOne) have taken a lead role in driving research and development of marketed liquid biopsy tests, hospital and reference labs can play a supporting role in accelerating market expansion by mirroring the investment in specialized molecular pathology and NGS testing capabilities which are foundational to liquid biopsy LDT proliferation. This proliferation would then drive clinical and real world evidence (RWE) generation and improve test availability once validated. 

Diagnostic manufacturers and labs must continue to innovate and gather data demonstrating the clinical utility of liquid biopsy tests at different points across the care continuum while also focusing on tailoring solutions to the specific unmet needs for oncology indications where possible.

Increasing use of targeted therapies will continue to help drive an increased patient pool size for LBx testing in therapy selection and recurrence monitoring, areas that are seeing growing LBx uptake.

Source(s): KPMG Precision Medicine Insights database; NIH

Healthcare providers: Take a more active role in driving adoption to help address fundamental barriers to broader usage for both treatment selection and MRD monitoring, including lack of reimbursement and clinical evidence

Use of liquid biopsy testing beyond therapy selection in the clinics today is still limited and this is attributed to multiple challenges, including:

• Reimbursement challenges constraining the use of liquid biopsy for early screening due to test accuracy and yielding of questionable clinically actionable information
• Tissue is still the preferred sample type if possible when it comes to therapy selection, given liquid biopsy may not be as accurate in identifying more complex fusions and other biomarkers
• Linking clinical outcomes to the utility of liquid biopsy in monitoring is still in its early stages

However, hospitals and AMCs can drive awareness, education, and improved testing outcomes by developing capabilities to conduct liquid biopsy testing in-house (in the form of LDTs). While RUO (research use only) kits may represent an attractive space for growth and revenue for diagnostic manufacturers, hospitals can leverage these RUO kits to improve familiarity and/or improvise their own LDTs.

At this time, diagnostic manufacturers and specialty labs are driving reimbursement initiatives, including public-private partnerships, test sponsorships, inclusion in treatment guidelines etc. but with healthcare providers taking ownership and driving more active participation in the development and refinement of liquid biopsy tests and access to these tests, the market may be able to unlock this potential more concertedly – not in the least by helping generate the RWE payers are increasingly focused on, and that help fill the data gaps that exist.