Diaceutics Group Report Reveals Significant Real-Time PD-L1 Testing Gaps in the US

PARSIPPANY, NJ--(Marketwired - Feb 3, 2016) - Diaceutics Group, a dedicated integrator in personalized and precision medicine, enabling the effective combination of therapies and diagnostics into the treatment pathway, today released data from its first tracking report on the PD-L1 diagnostic space, revealing a complex picture of performance, adoption and usage. The report was announced at the Pharma Market Research Conference in Parsippany, NJ and combines data from specifically commissioned primary research and proprietary databases to provide the first real-time comprehensive landscape of novel biomarker usage.

"Despite two major pharmaceutical companies supporting the launch of new diagnostics in the PD-L1 space for melanoma and non-small cell lung cancer (NSCLC) to date, the danger was always there that PD-L1 testing would not have a clean adoption curve," said Steve Vitale, Head of Diaceutics Analytics, Insights and Strategy (AIS) division. "This first comprehensive portrait of PD-L1 as a novel biomarker reveals the uncertainties surrounding a new test when the indications for use and interpretation are not clear cut."

Although 73% of physicians strongly agree with the fact that PD-L1-positive patients would benefit from immunotherapy in the first line of treatment along with chemotherapy, 43% of PD-L1-tested patients receive non-PD-L1 therapy and 40-45% of patients receiving PD-L1 therapies are also being tested for EGFR and ALK mutations.

In terms of the propensity to prescribe (conversion rates between testing and treatment), 38% of Opdivo-prescribed patients have been tested for PD-L1 and 39% of PD-L1 tests run are IHC 22C3-indicated as a prerequisite for prescribing Keytruda.

Despite the availability of FDA-approved kits, 75% of labs offering PD-L1 testing to date have decided to develop their own LDT following a pattern of novel test introduction seen with most other IHC tests. 

"Our pre-test launch research with labs confirmed that most pathologists were unlikely to purchase two different kits for the same biomarker and this seems to be borne out in early practice," said Ryan Keeling, Head of the Labceutics division of Diaceutics. "However, we have still some way to go in terms of optimizing the lab-to-physician service levels of PD-L1 tests with only a third of physicians happy with the PD-L1 test turnaround time."

The industry communications surrounding PD-L1 testing to physicians fall into a category Diaceutics describes as 'discordant', which indicates that the clinical literature push for testing is greater than the industry push for testing. This "should we-should we not test" debate for PD-L1 is likely to be mirrored at most major oncology conferences this year and reflects the lack of clinical consensus surrounding this novel biomarker and its utility.

The analysis also looks forward to the indications and therapy launches likely to be dependent upon the PD-L1 testing ecosystem in the next 12 to 18 months. With half of all phase three trials in NSCLC including PD-L1 testing, the dependence of therapy market share on a seamless and efficient testing market will increase exponentially. Also, the overlap with EGFR and ALK in these same phase three NSCLC trials predicts the landscape of multi-marker testing guidelines, which are likely to unfold.

"We have always had to look retrospectively at novel test introduction and adjust strategies late in the game," said Vitale. "We believe novel PD-L1 and other key biomarker tracking will accelerate industry response to the adoption curve for these key cancer tests."

Those interested in the Real-Time Tracking report can contact:
Mark Reis, EVP Business Development, 347-708-2223, mark.reis@diaceutics.com

About Diaceutics Group
Diaceutics Group, a dedicated integrator in personalized and precision medicine, leverages analytics, software, services and consulting to enable the effective integration of therapies and diagnostics into the treatment pathway. The Group's four divisions, Analytics, Insights and Strategy (AIS), Labceutics, Bioceutics, and Iceutics, together provide a comprehensive suite of services to ensure that testing enables therapy prescribing across all key markets.

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