Key Insights & Takeaways: American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo

The Clinical Chemistry Annual Meeting did not disappoint with great attendance, engaging talks, and some innovative exhibits. After digesting all our notes (and a bit of Chicago’s finest culinary fare) from the busy week, we walked away with five key takeaways:

Innovative culture on display

If new products and technologies capture your attention, the Clinical Expo did not disappoint. Headlined by the Disruptive Technology Award winner, Nanopath, who led with a solid-state biosensing platform that removes the need for nucleic acid amplification. However, the Clinical Expo was full of new product launches, with some breaking new ground, such as Angle, plc with a system for harvesting cancer cells from patients’ blood for analysis. As expected, a stream of Monkeypox virus controls and assays were starting to be announced to address the now declared public health emergency. With promising innovations come questions about their ability to displace existing technologies, improve testing workflows, the size of addressable markets, and go-to-market plans. Members of the Kx team support clients by answering these types of questions every day and can assist you in thinking through how best to tackle these issues.

Still have VALID fears

On the heels of Europe having a regulatory shakeup in diagnostics (In-Vitro Diagnostic Medical Devices Regulation (IVDR) implementation), it seems likely the United States is about to follow suit with the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) coming to a vote in Congress as early as next month. With so many clinical laboratorians converging on the conference, we expected to hear various positions and forecasts. AACC organizers did an excellent job putting forward an update through a session titled “Valid Vital LDTs: Current State of Regulation Legislation of Laboratory-Developed Tests.” However, we are left with the impression several laboratorians are upset with the impact this legislation could have on their business. Kx Advisors is keeping a close eye on this legislation and will be providing an update as the situation evolves. Get in touch if you would like to be kept informed and up to date on the latest developments.

Tech influences testing

Algorithms, connectivity, and smartphones were highlighted not only on the main stage, but across the Expo floor. Artificial intelligence and machine learning were featured in Dr. George Church’s plenary session discussing how machine learning will support a laboratory’s desire for multiplex testing, simultaneously gathering anywhere from tens up to billions of data points. On the show floor, we saw several connectivity products and features on display falling into two basic categories. First, solutions, such as Planet Innovation’s NeoSync(TM) and BrightInsight’s Connected Diagnostics Platform, focus on flexible configurations that may integrate into existing or future medical devices. The second category leverages smartphones as a connectivity conduit, with applications spanning from mobile phlebotomy to test analysis for blood clotting, infectious disease and more. Implementation of connectivity and algorithm-driven testing schemes as either products or product attributes require a strong understanding of testing behaviors and user segmentation. Kx Advisors utilizes novel behavioral modeling, and environment/user segmentation frameworks to support prioritizing the ideal tech-enabled features and products.

Character matters

As an industry, we all watched the collapse of Theranos, and the subsequent convictions of Elizabeth Holmes and Ramesh Balwani on fraud charges. These events surfaced discussions on the intersection of startup culture and clinical diagnostics, public trust in laboratory medicine, and the role of government oversight. AACC organizers wisely “read the room” and highlighted a discussion on ethics and accountability with Theranos whistleblowers, Erika Cheung, and Tyler Shultz. As a part of the diagnostics community, I applaud the efforts of AACC to facilitate these discussions.

Thank you, Chicago!

Chicago offers more than hot dogs and pizza – If you read our previous post about the hot topics of AACC, Bob Serrano and I voted for our favorite Chicago signature foods. Well, thank you Chicago for some amazing food and great hospitality— even if we missed grabbing a dog.

How Kx Can Help

Discuss more on the latest developments in diagnostics and life sciences or our key takeaways from the 2022 American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo. Contact Brian McNally, PhD

Contact Our Team Today

Q&A with Kx: Spotlight on AACC 2022

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 or Brian McNally, PhD

Contact Our Team Today