What We'll Be Looking Out For at #ADLM This Year

ADLM (formerly AACC) starts Sunday, Eye on IVD will be there to report and also to gather market info for our upcoming market research reports.

LDTs and the FDA LDT Rule Current Status: It will be interesting to see how the recent events involving the FDA's new rule on lab-developed tests will change the discussions at this association which has not been a fan of the rule.

The LDT rule has lost some of its footings with three blows to it: The resignation of a chief FDA regulatory officer, the Chevron deference loss in the recent Supreme Court ruling, and the recent admonishment by a House Appropriations Committee (Agriculture / FDA) that it will "drastically change" the infrastructure of American laboratories and they should not be enforcing the rule.

Nonetheless, the LDT is regulatory policy right now and for the moment at least, laboratories must comply ADLM conducted a survey to learn directly from labs whether the FDA rule’s exemptions will help or hurt their testing capabilities. The survey went out to clinical laboratories across the U.S. and received responses from 128 of them Despitef the rule’s exemptions, the majority of respondents said that they do not have the staff or resources to fulfill the FDA requirements that exemptlaboratory-developedd tests will still have to meet. And more than half of the labs that won’t be able to comply with these requirements anticipate discontinuing some of their exempt tests.

Mass Spec in IVD: 25 Vendors at ADLM will offer solutions related to mass spectrometry, including systems, lab tests, and parts manufacturing. Roche will unveil its Mass spectrometry-based solution, the future cobas? Mass Spec solution*, which is a total end-to-end solution for clinical mass spectrometry testing with the goal of seamless integration into the routine laboratory. Roche is not the only company with offerings including mass spectrometry.

Just bringing mass spectrometry to the laboratory is one thing, improving it so it can be more routine is another. Some vendors are focusing on automation and improvements. Waters, a traditional mass spectrometry company will be at ADLM with its MassTrak ACQUITY UPLC I-Class PLUS/Xevo TQ Absolute IVD System is a compact, sustainable analytical instrument that accurately quantifies trace analytes with absolute power. The company's Waters's MassXtract STARlet assay-ready workstation automates mass spectrometry sample preparation. The platform strategically enables both protein precipitation and solid phase extraction to offer greater functionality in a smaller footprint.

Sebia offers M-inSight, which is a personalized, targeted mass spectrometry assay, to detect with sensitivity the monoclonal protein (M-protein) secreted by the patient’s tumor cells in serum. The technology is based on clonotypic peptides mass spectrometry, which avoids the interference with the polyclonal background leading to an ultra-sensitive test.

Other companies with Mass Spec offerings include: Autobio Diagnostics Co., Ltd. bioMerieux, Hamilton Company, HORIBA, Immundiagnostik AG, Indigo BioAutomation, Landwind Medical, MassSpec Medical, MK Fluidic Systems, Moeller Medical GmbH, National Institute of Standards and Technology (NIST), OPTIMA Machinery Corporation (WI), Rapid Infection Diagnostics Inc, SCIENION US, SCIEX, Sebia, Shimadzu Scientific Instruments, Inc., Tellgen Corporation, Thermo Fisher Scientific, Virant Diagnostics.

Mosquito Control and TBI and Alzheimer's Testing: My personal targets will be anything infectious. However I find Co-Diagnostics's vector control mosquito surveillance test will be interesting. I'll also be looking out for neurology tests. Abbott and other vendors have these tests, it will be interesting how they position them or what they say about them.

An Average American Hospital Using Next-Generation Sequencing: Doylestown Hospital is a 247-bed hospital in Pennsylvania. It's not the kind of facility that one might associate with the use of sequencing, but all those associations should change - the role of this technology is different and I've seen informal surveys showing increasing use of NGS at community hospitals. Thermo Fisher Scientific will sponsor a talk at ADLM where Doylestown will present how it uses NGS in patient care. Dr. Allison Eck, director of pathology and Laboratory Medicine at Doylestown Health, will lead a presentation, Results of Bringing Rapid Amplicon-based Sequencing to Doylestown Hospital, explaining how her lab successfully brought NGS testing in-house to facilitate shorter turnaround times, drive down costs, and enable more efficient use of resources.

Cardiac Troponin, with a Human Touch - Abbott will host "The Highs and Lows of Cardiac Troponin: What Your High Sensitivity Assay is Measuring and What Might it be Missing?" High-sensitivity (hs) cardiac troponin assays have revolutionized the care of patients with suspected myocardial infarction (MI), enabling faster triage and more accurate diagnostic protocols. However, interpreting cardiac troponin results necessitates consideration of patient-specific and assay-specific factors. This expert-led session will address the analytical and clinical aspects of both high and low hs-cardiac troponin results, while also examining factors that could lead to potential misdiagnosis of MI.

Faster AST: AST results in hours - bioMérieux received recent US FDA 510(k) clearance for its AST System VITEK? REVEAL bioMérieux recently announced that its VITEK? REVEAL? AST System. The system reports results directly from positive blood cultures, has a very short (3-minute) prep time, and can handle multiple patient samples at one time in one shift.

Better B12 Testing? Randox announces Vitamin B12 Test Controls -Vitamin B12, or cobalamin, is a vital water-soluble vitamin that plays an essential role in myelination initiation and development, cellular energy, and fatty acid metabolism. Vitamin B12 deficiency can be the result of dietary insufficiency and malabsorption resulting from damage to the small intestine, often caused by conditions like Coeliac disease or Crohn’s disease, or via pernicious anemia – an autoimmune condition that results in an inability to absorb Vitamin B12. Randox presents Acusera Active Vitamin B12 Control Designed for use with in vitro diagnostic assays for the quantitative determination of HoloTC in human serum and plasma and is suitable for use on a variety of analyzers

This true third-party control is provided in a liquid ready-to-use format, reducing preparation time with an impressive 30-day open vial stability, helping to minimize waste. Like all Acusera controls, the Active B12 Control is supplied at consistent, clinically relevant levels to ensure the test system is challenged at the critical decision limits used to aid diagnosis. Furthermore, this control is provided with assayed target values for a range of analyzers which are available through our new SmartDocs portal.

Faster Test for Pediatric Kidney Injury: Area of innovation over the years. Ortho and other vendors looking for KI to receive the focus that sepsis has gotten over the years. BioPorto's ProNephroAKI (NGAL) which is designed to help doctors identify patients at risk of moderate-to-severe AKI in the intensive unit (ICU) setting. The test measures biomarker neutrophil gelatinase-associated lipocalin, or NGAL, a clinically validated marker of kidney cell damage that BioPorto says can detect AKI days earlier than the current standard of care, which is serum creatinine measurement.

CLIA-waived Sore Throat Test: bioMérieux received Special 510(k) clearance and a CLIA-wavier for its sore throat test. The test for 4 of the most common respiratory viruses (including influenzas) and Streptococcus A, from one throat swab, all at the same time. The company says the BIOFIRE? SPOTFIRE? R/ST Panel Mini is a unique multiplex PCR* test that detects 5 of the most common viral and bacterial causes of respiratory or sore throat infections1 in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected.

Liat at Last? While Abbott built increased business with POC respiratory, Roche has seemed to this observer to put greater corporate focus on large systems and oncology. This year, this might be changing a bit. Roche is putting an increased emphasis on its Cobas Liat and has a new combo assay. The cobas? liat system brings gold-standard PCR technology to the point of care, providing results within 20 minutes across a growing menu of assays, now including the cobas liat SARS-CoV-2, Influenza A/B & RSV assay** to test for four common respiratory viruses, all in within one test. The cobas? eplex system, a rapid syndromic molecular diagnostic solution, has been updated with new features across all aspects of the workflow process.

Keep watching here for more developments.