2018 Market Ready Rx Roundup

This year was clearly a turnaround year for the In Vitro Diagnostic industry, providing proof that all diagnostic products in the future must drive individual patient decisions.

From the timely NGS coverage decision in March, making reimbursement available for all cancer patients, to PD-L1 testing to guide Immuno-Oncology treatments, personalized diagnostics have touched every facet of medicine in 2018. Below is a brief roundup of Market Ready Rx IVD commercial highlights from 2018 which we were proud to support.

We wish you and your family a joyful holiday season filled with the spirit of optimism and generosity to others.

Martha Townsend
President, Market Ready Rx

Next Generation Sequencing hits its stride

• In 2018, Market Ready Rx met with NGS Key Opinion Leaders to understand how NGS will impact the oncology market globally, as well as how NGS results will be integrated in a current standard of care. In a global roundtable discussion and subsequent market research, we learned that Oncologists are anxious for evidence-based tool like NGS to inform their patient treatment decisions; a clear rule-in / rule-out during a first meeting with a cancer patient to help them choose the most effective drug is critical. It became clear that a single NGS test is highly desired by both Pathologists and Oncologists over multiple individual tests in order to spare precious tissue sample and arrive at a clinically actionable answer more rapidly.
• A momentous decision to reimburse NGS testing took place in March 2018, driving additional commercial progress of new product launches in the NGS space. A US CMS national coverage decision for NGS supported both the reimbursement of two key Companion diagnostics, FoundationOne and Oncomine Dx, and surprisingly, agreed to support reimbursement of NGS mutations which allow patients to be entered into clinical trials.
• Despite investor enthusiasm for Liquid Biopsy, demonstrated by the $1.59 billion Guardant Health valuation public offering on October 3, 2018, as well as investor confidence of $1 billion to date for Grail, Oncologists remain cautiously optimistic.
  • In a March 2018, ASCO released a review entitled “Liquid Biopsy Tests in People with Cancer: An Expert Review. More Evidence Needed to Establish Effective and Appropriate Use in the Clinic.” The article highlights unanswered questions surrounding liquid biopsy including, “What is the evidence to support ctDNA in the clinic for specific clinical scenarios?” Other than the FDA approved cobas EGFR liquid biopsy test, no other test appears ready for prime time.

Personalized Diagnostic programs are evolving beyond one specific indication

• Market Ready Rx remained active in commercial launches for PD-L1 testing during 2018. Based on the success of Immuno-Oncology drugs available from multiple pharmaceutical companies across multiple indications (Non-Squamous Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma, Urothelial Cancer, Gastric Cancer, etc.), we anticipate more broad-based single tests across many indications in the future. Continued education at the Anatomic Pathology tissue testing lab and with Oncologists will be necessary in 2019.
• To this end, the FoundationOne and Oncomine Dx tests were both FDA approved for drug guidance across multiple cancer types – the first single NGS tests approved for pan-cancer indications.
• Additionally, in December 2018, Loxo Oncology obtained FDA accelerated approval for the TRK inhibitor Vitrakvi with NTRK gene fusion Companion Diagnostic test. We anticipate that this Companion Diagnostic approval (based on one genetic change regardless of cancer type), could signal a change in precision medicine, focused more on genetic properties versus site of origin.
• Across other areas of diagnostics, we are working with Molecular Microbiology clients who are exploring personalized diagnostics to guide antibiotic selection with a sophisticated molecular antimicrobial susceptibility testing system, further illustrating the widespread shift to personalized medicine across all areas of patient care.

The FDA is introducing new guidelines for submission of 510K

• The FDA has announced that it will change its 510(k) pathways to rely less on older (greater than 10 years old) predicate devices and require new medical devices to compare with more current predicates or demonstrate that they meet more stringent performance criteria.
• As a commercial team, we anticipate disruption and more careful commercial planning requiring integration with regulatory in 2019

Contact Market Ready Rx for an introductory consultation should you wish to explore how Market Ready Rx can support your organization.

• Diagnostic marketers have limited bandwidth to do everything they want to do in the launch of a personalized diagnostic.
• The Market Ready Rx team integrates into the organization to provide specialized diagnostic marketing support.
• Allowing marketers to confidently execute a high quality personalized diagnostic launch with limited resources.
• We make your life easier.

To learn more about our services, checkout: marketreadyrx.com