It’s been our honor to cover our first ADLM meeting as EYE ON IVD Newsletter. We thank the ADLM Press Office for coordinating with us, and vendors for providing us with new developments. Look out for our WHITE PAPER “What You May Have Missed at ADLM 2024” Coming Soon.
On Thursday, the ADLM (formerly AACC) announced that 18,000 laboratory medicine professionals had registered for the Chicago meeting, with the number sure to go up with today’s walk-ins. The association reports a 6% increase in attendance since the last time ADLM was in Chicago in 2022.
COMPANIES WANT TO SELL TO LABS: Here’s a relevant point for those like us that are tracking the related in vitro diagnostic (IVD) market. That attendance figure doesn’t separate out the thousands of exhibitors in IVD companies [also lab pros] that come to the meeting. ADLM said nearly 900 exhibitors purchased 271,003 net square feet of exhibitor space — which the organization said was a 5% increase since the last time the meeting was held in Chicago.
AMA POINT OF VIEW ON LDTS: More commentary from Tuesday’s ADLM Session on lab-developed tests: Geoff Hollett, PhD, a senior policy analyst representing the American Medical Association, emphasized how the new FDA rule will undermine clinicians’ ability to provide care. “FDA’s rule was developed at lightning speed with minimal input from the public,” Hollett added. He highlighted the uncertainty surrounding the final rule, stating that with uncertainty comes abstention: “Practices will close, effective tests will not be offered, and patient care will get worse because of fear of noncompliance.”
“FDA’s rule was developed at lightning speed with minimal input from the public,” – Greg Hollett, American Medical Association
Representing the Children’s Hospital Association, Meghan Delaney, DO, MPH, commented on the vital role of LDTs in pediatric care, emphasizing the devastating impact of the new FDA rule on this patient population. “There is no difference in how [FDA approved and laboratory developed] tests perform,” Delaney said. “They are accurate and provide clinical information for patients and physicians.” She also noted that the additional administrative burden and associated costs have serious implications for their ability to provide timely diagnostics for the nation’s children. Sarah Braswell, a caregiver and patient advocate, rounded out the presentations by illustrating the value of LDTs from a parent’s perspective. Sharing the story of her daughter, Olivia, Braswell detailed the critical role LDTs have played in ensuring the highest quality of care in diagnosing and managing Olivia’s Down Syndrome. Given that individuals with Down Syndrome are at an increased risk of developing health conditions such as cancer, Braswell regularly advocates for timely testing for Olivia, many of which are LDTs.
FIRST COLON CANCER BLOOD TEST APPROVED – Not part of ADLM officially, but corresponding with the meeting, a large development in liquid biopsy: The Food and Drug Administration approved Guardant Health’s blood test, Shield, to screen for colon cancer, offering, the company says, a promising alternative to boost low screening rates for the second-leading cause of cancer death in the U.S. The American Cancer Society estimates over 53,000 colorectal cancer deaths this year.
THE “NEW” NGS AND MICROBIOLOGY STANDARDS – When a product is already called ‘next generation’ it draws interest but leads to a problem – when can you have another next generation? When in the early 2000s, NGS came on the scene, it was an improvement over the slower systems. But now, NGS systems are not all one stripe, some have automation or targeting features that can increase their function.
THERMO TOUTS NGS FOR MICRO: Because of automation and metagenomic targeting, Thermo Fisher says NGS may become part of microbiology routine. “Standard microbiology testing approaches often depend on the recovery and culture of viable organisms, limiting their use.” The answer – automation and targets to take the work and risk off the user. Thermo says custom AmpliSeq-targeted NGS panels can be used with the Genexus Integrated Sequencer to deliver NGS test results in as little as 24 hours.
ACUTE PEDIATRIC KIDNEY TEST BOOSTED BY STUDY: Studies show that as many as one in four children are at risk of developing AKI during hospitalization, and this is associated with prolonged hospital stays, increased risk of in-hospital death, and future progression to chronic kidney disease. Boston, MA, and Coppenhagen-based BioPorto Diagnostics promoted their NGAL Test product and a clinical trial starting that is based on the test. ProNephro AKI (NGAL), BioPorto says, provides an additional data point for clinicians to identify patients aged 3 months through 21 years at risk of developing or having persistent, moderate-to-severe AKI within 48-72 hours after intensive care unit (ICU) admission. The U.S. Food and Drug Administration (FDA) has already cleared the test for assessing acute kidney injury (AKI) in hospitalized children (ages three months through 21 years). This makes NGAL Test the only product for this purpose right now.
The biomarker the test is based on, NGAL (neutrophil gelatinase-associated lipocalin) is a direct real-time marker of kidney cell damage and, the company says, can potentially detect AKI days earlier than traditionally used serum creatinine (SCr) functional test. BioPorto touted “Combining Biomarkers and Electronic Risk Scores to Predict AKI in Hospitalized Patients,” a clinical trial study actively recruiting participants. The study, accessible at https://clinicaltrials.gov/study/NCT05988658, features a detailed exploration of the role of NGAL as a biomarker in conjunction with electronic risk scores to predict the risk of AKI in hospitalized patients more accurately.
BEING ALGORITHM-WARY: Labs and AI have been touch and go, and ADLM sessions reflect this. Lab pros know there are benefits, but nobody sees downsides faster than the folks who are running tests and interpreting them. “Algorithms are not training in some fair universe, they train in our reality with all our warts and issues.” Mark Zaydman, MD, PhD said in an ADLM session “Ensuring Equity and Fairness in Machine Learning and Data Analytics.”
This talk provided a primer on algorithmic fairness, equipping laboratorians with the necessary tools to safely deploy algorithms for patient care. Zaydman introduced algorithmic fairness, discussed the uses and limitations of various approaches, and used the Obermeyer study to illustrate algorithmic bias. (In that study, it was shown that African American patients had to be sicker to receive the same healthcare resources from the algorithm than patients of other races). Weishen Pan, PhD, explained why machine-learning algorithms generate unfair outputs and presented his research on causal inference methods to identify drivers of algorithmic bias. Jenny Yang, MSc, BASC, focused on engineering fair algorithms at all stages of development, sharing examples from her research on COVID-19 prediction tools. Attendees left with an understanding of algorithmic bias, its roots, and tools for ensuring fairness, highlighting the importance of incorporating fairness into the criteria for successful algorithms in laboratory medicine.
NEW APPROACHES TO HIV PREVENTION: When it comes to prevention, better to have more options than one. If the only option is an oral medicine, that will help some but not all.
On Wednesday, Dr. Sharon Hillier, a professor at the University of Pittsburgh, explored the development of new products for HIV prevention, including those that can be used on demand and those that would minimize systemic exposure to antiretroviral drugs. Hillier highlighted the high efficacy of PrEP when used properly, but noted a significant lack of adherence, with only about 25% of participants maintaining consistent use after three months. She compared effective HIV prevention to a bridge, facilitating normal life without disruption, and emphasized that options like abstinence, condom use, and oral PrEP may be ineffective for some individuals.
Newer methods like injectable PrEP and drug-containing vaginal rings show promise, with supportive results from the PURPOSE 1 trial demonstrating no HIV infections among 2,134 women using the long-acting lenacapavir (LEN-LA) PrEP option. Hillier stressed the importance of providing diverse prevention options to better meet individual needs.
A milestone – EYE ON IVD NEWSLETTER has grown 7% in our subscriber base since ADLM 2024 started. If you are new, remember to pass along the word to those in the industry who might be interested. We will also be offering market intelligence tools shortly, we are at work on those as we speak. Upcoming market estimates in infectious disease IVD and lab-developed tests, contract manufacturing and general in vitro diagnostics are forthcoming.
