IVD Industry Battles AMR, Touts Biotin-Free Immunoassays and Smaller Footprints at the 2018 American Association for Clinical Chemistry Meeting

Press Release
Aug 2, 2018
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Rockville (MD), August 2, 2018 — Global in vitro diagnostic vendors and the laboratory professionals that make up their customers made the fight against anti-microbial resistance (AMR) a key focus of the American Association for Clinical Chemistry (AACC) meeting in Chicago, IL this week.

With easy-to-grasp names like Zika and Ebola, viruses tend to get more headlines. But a great global risk to human health has arrived from the overuse of antibiotics and the resulting, nameless, antibiotic-resistant bacteria. The use of antibiotics has reached the point where it is difficult to stay ahead of the mutation curve. Each year in the United States, methicillin-resistant Staphylococcus aureus (MRSA) is responsible for 80,000 infections and 11,000 deaths. Close to 250,000 people are hospitalized every year for a Clostridium difficile (C. difficile) infection, and 14,000 of them die.

"With payors scrutinizing the costs of labs in the U.S. and Europe in particular, it makes all the sense in the world that they would highlight an area where there is a cost to reducing testing, and that is anti-microbial resistance," said Bruce Carlson, Publisher of Kalorama Information which produces a regular market study on the IVD industry . Kalorama is at the Chicago meeting speaking with in vitro diagnostic vendors and has been noting significant developments.

As an example, Becton Dickinson displayed the company's BD Veritor PLUS immunoassay test for respiratory diseases in the center of the overprescription issue. Orion Diagnostics touted its compact QuikRead go CRP test, a two-minute liver inflammation biomarker test that can assess the efficacy of antimicrobial therapy and the course of infection. Roche Diagnostics highlighted their Liat systems that can quickly assess flu or strep, and thus reduce unnecessary treatment.

For bioMerieux, faster blood cultures and improved IT is the company’s answer to AMR. The company, a member of the AMR Industry Alliance, displayed its BacT/Alert Virtuo at the meeting. BacT/Alert Virtuo is an advanced, automated blood culture system incorporating improved automation and an enhanced detection algorithm to shorten time to detection. BioMerieux's system allows the operator to merely place the sample in tray and the system reads labels, processes and sorts. These are techniques used on chemistry and immunoassay systems, adapted to microbiology. The company says the time saving features of the system can save three hours in the blood culture process, an important time period for a critically ill patient. The speed has not harmed accuracy apparently: A study last year in the Journal of Clinical Microbiology showed that the system earned results comparable to those produced by the long-established systems.

In addition, other developments were noted by Kalorama Information:

  • Biotin Resistance - Biotin supplements to promote healthy hair have become popular, but they also can interfere with some diagnostic results. While patients are advised to tell their doctor, this isn't always practical. This year's AACC saw vendors touting biotin free testing. Randox Laboratories uses a biotin-free Biochip Array Technology, which was highlighted at the meeting. Abbott and TOSOH also have biotin-free immunoassays promoted at the meeting. Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins and supplements.

  • Two Decades of CfDNA - Two decades has passed since the awareness of the existence of cell-free fetal DNA in the circulation of pregnant women. Since 2011, noninvasive prenatal screening of fetal chromosomal aneuploidies, such as Down syndrome, has been implemented for clinical use and supported by professional practice guidelines. Now each year, millions of women opt for this screening modality resulting in substantial reductions in the rates of amniocentesis. Beyond chromosome aneuploidy screening, cell-free fetal DNA testing approaches have been developed for the noninvasive assessment of fetal single gene diseases, fetal de novo mutations, and the monitoring of pregnancy-associated complications. Information from cell-free fetal DNA analysis continue to drive new insights into pregnancy physiology and pathologies.

  • Testing and Transgender Patients - Novel findings unveiled at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo show that gender-affirming hormone therapy markedly impacts the results of common laboratory tests for transgender patients. This study underscores the need for transgender-specific reference intervals to ensure this underserved population receives accurate diagnoses and effective treatments. A research team led by Jeff SoRelle, MD, of University of Texas Southwestern Medical Center in Dallas, investigated whether transgender patients on hormone therapy exhibit altered results for laboratory tests ordered during yearly check-ups. The study authors recorded lab values for a complete blood count, comprehensive metabolic panel, and lipid tests in 264 healthy transgender patients undergoing hormone therapy in transgender clinics from 2007 to 2017. Of these patients, 133 were taking estradiol to transition from male to female, and 89 were taking testosterone to transition from female to male. The scientists also gathered lab results for 149 transgender patients not undergoing hormone therapy to serve as a point of comparison. From this, the researchers determined that both transgender women and men taking hormones displayed altered values for measures of red blood cell, kidney, and liver health.

  • Paper-Sized C. diff. System - Meridian Biosciences highlighted its "size of a piece of paper" small footprint system, Alethia, featuring tests for C. diff., Group A Strep, Group B Strep, HSV 1&2, among other tests. The system uses LAMP molecular amplification technology which enables the smaller footprint.
  • AI-Fueled Test Development - Seoul, Korea-based Seegene highlighted their SGDDS digitalized development system for high multiplex real PCR. The company says the AI-based system integrated with Seegene's technology allows for the automatic design of sets of oligonucleotides for high multiplex real time PCR assays. The company claimed the system can take less than a month to develop customize tests where human development would take over a year.

  • Reducing Confusion on TSH Tests - Thyroid function tests such as hormone (TSH) and free thyroxine (fT4), are cornerstones for disease diagnosis and monitoring. But the tests are confounded by biological and diurnal variation, severe illness, non-pathological states such as pregnancy, and inter-assay variability. Professional guidelines for diagnosing and managing thyroid illnesses offer direction on best practices for the use and interpretation of TFTs, but the evidence-based applicability of the tests is hampered by the wide variability of results across commercial immunoassays. In a scientific session on Monday, Joely Straseski, PhD, and Ann Gronowski, PhD, discussed how normal pregnancy affects the physiology and functions of the thyroid gland in a scientific session.

  • Taking on AKI - Acute Kidney Failure affects 3.2 million patients in U.S. hospitals each year, and is a danger rivaling sepsis. Patients with AKI may need to avoid certain medicines and avoid MRI contrast agents, necessitating testing. This was the one of the focus on bioMerieux's exhibit as well as that as OrthoClinical diagnostics. Both companies presented the Nephrocheck line of small-footprint rapid AKI testing. At a talk during the CLinical Expo, Dr. Eric H. Gluck from Swedish Covenant Hospital in Chicago, IL demonstrated the use of PCT and Nephrocheck to benefit outcomes.

  • First-pass Accuracy Urinalysis - Sysmex displayed its first fully automated urine particle analyzer. The new analyzer reduces the need for manual slide review and delivers first-pass accuracy and unprecedented workflow efficiency. The UN series consists of three analyzer modules and is the first fully configurable urinalysis solution to offer expanded parameters. The innovative analyzer is awaiting U.S. Food and Drug Administration (FDA) clearance for sale in the U.S. Sysmex also unveiled an enhanced hematology system, the FDA-cleared XN-20 complete blood count (CBC) analyzer, a complementary system to its XN-10 with additional reagents.

Kalorama will publish its Worldwide Market for In Vitro Diagnostic Tests, now in eleven editions, on August 27th.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama’s website and are also available on www.marketresearch.com and www.profound.com.

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