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Q&A with Kx: Spotlight on AACC 2022

Bob Serrano
Managing Partner
Brian McNally, PhD
Vice President

Q&A with Kx: Spotlight on AACC 2022

American Association for Clinical Chemistry (AACC)
2022 Annual Scientific Meeting & Clinical Lab Expo
July 24 -28, 2022
McCormick Place Convention Center
Chicago, Illinois USA

Before they head off to the Windy City for this year’s AACC Annual Scientific Meeting & Clinical Lab Expo, we asked Bob Serrano and Brian McNally for their insights on what they hope to learn, see, and are excited to discover at this year’s conference!

Q: What takes life science growth strategy consultants to the American Association for Clinical Chemistry Annual Meeting?

Bob: At Kx Advisors, we focus on partnering with life sciences clients to deliver actionable insights that fuel growth. Clinical diagnostics has always been a market with technical innovations, but now more than two years since the start of the COVID-19 pandemic, we see significant investments being made. Those investments are in a market where patients demand greater value from testing. Models that decentralize molecular diagnostics right into our homes or adding genome sequencing to doctor’s visits, are both examples of those new models. Conferences like AACC are a great venue for us to listen to various perspectives and share our own insights.

Brian: As a former bench scientist, I find myself drawn to new products and technologies. After all, new gadgets in clinical diagnostics hold the promise of a healthier future for all of us. With almost 300 new exhibitors since 2019, I’m excited to see the future of diagnostics in the lab and at home. So, you can expect to find me talking to exhibitors about their new study results and how they expect it will bring greater value to labs.

 

Q: What do you expect to be the hot topics in laboratory medicine?

Brian: While COVID testing is here to stay given the endemic-like nature of SARS-CoV-2, we see three outcomes of the pandemic impacting the labs. First, pandemic preparedness. We see this being tested with the spread of new SARS-CoV-2 variants as well as monkeypox. Second, advances in characterizing host-pathogen interactions, brings a new dimension to supporting clinical practice from diagnosis through treatment. Lastly, we expect labs will be sharing their perspectives on how to support patients with post-COVID syndromes.

Bob: I expect a hot topic for attendees will be what the inclusion of Verifying Accurate Leading-edge Development (VALID) into the Medical Device User Fee Amendments (MDUFA) will mean for innovation. VALID establishes a risk-based framework for in vitro clinical test (IVCT) regulation, which would give the FDA authority over LDTs (laboratory-developed tests). AACC has asked its membership to oppose VALID’s inclusion, while the industry group AdvaMed has endorsed VALID. So, while VALID’s language is not yet finalized, and there is a proposed five-year phase-in, we still expect to hear a lot from the Expo attendees on how VALID is going to impact them. Specifically, how will a risk-based regulatory structure be applied to new testing models that are less hypothesis-driven, and more proactive?

 

Q: What technologies do you see making headlines on the Expo floor?

Bob: While the headlines might be from earlier this year, the news surrounding decreasing costs of next generation sequencing will resonate with clinical laboratories. Costs are a key barrier to the recent push we see for comprehensive genomic profiling (CGP). At this past month’s American Society of Clinical Oncology meeting, Illumina hosted a networking event where a panel of clinicians shared case studies where CGP was transformational for the patient. The panelists went on to describe reimbursement as a barrier to adoption; so obviously, if costs keep decreasing, we could see CGP’s growth accelerate.

Brian: AACC does a fantastic job of providing some built-in technology headlines with the Disruptive Technology award. This year, there are three finalists who we expect will be getting a lot of attention moving forward. First, the Verita™ lab-on-a-chip platform by Biological Dynamics offers a nanoparticle-based isolation solution for streamlined multi-omic testing. This type of platform technology should garner broad appeal with biomarker discovery groups as well as assay developers. Next, Nanopath has focused their attention on women’s infectious diseases and looks to use their expertise in nanotechnology to offer a compelling physician office testing platform. Lastly, Visby Medical has launched a palm-size PCR testing platform for COVID and sexually transmitted infections. All these finalists are great representatives for the trends we have seen coming in the molecular diagnostic space, so now we need to find what’s next.

 

Q: What do you expect to share with your clients when you get back from the Meeting & Expo?

Brian: With COVID bringing diagnostic testing into our homes, we have all participated in the adoption of decentralized diagnostic testing. Now we are looking at the next wave of patient-focused testing, both in the home as well as distributed throughout the healthcare setting. The innovations we see coming are not only from the test technology, i.e., how fast can PCR be done, but how the tests fit into these new environments, and how they communicate with the broader healthcare system.

Bob: An event like AACC is a great way to share perspectives and gather experiences firsthand from the clinical laboratory. The insights I expect to share with our clients will then be focused on how laboratories are going to deliver value to patients. As an example, how can labs deliver greater clinical insights in a post-VALID environment? And what impact will greater competition in the genomics space have? So, we look forward to hearing perspective of the labs, the diagnostic developers and partnering with them to help identify the best way to help patients and clinicians.

 

Q: Last question for you both, Deep Dish Pizza or Chicago Dog?

Brian: Chicago Dogs for me. No way to pass up all those toppings.

Bob: Deep Dish all the way! More specifically, Deep Dish from Pizzeria Due, the original chain restaurant of Pizzeria Uno. This is the true pride and soul of Chicago. 🍕

 

How Kx Can Help

Discuss more on the latest developments in diagnostics and life sciences (or the great pizza vs. hot dog debate of 2022), join us in Chicago for AACC Annual Scientific Meeting & Clinical Lab Expo.  Contact Bob Serrano bob.serrano@kxadvisors.com or Brian McNally, PhD brian.mcnally@kxadvisors.com

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