Record-Breaking Meeting of IVD and Lab Industry Tackles Key Healthcare Issues

Record-Breaking Meeting of IVD and Lab Industry Tackles Key Healthcare Issues

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Following on the heels of ComicCon is a tough job for any meeting, but the superheros of the lab industry nonetheless met in San Diego right after that large and popular convention and hit the same city to tackle big problems in healthcare at the American Association for Clinical Chemistry meeting last week. Along with them, the top companies in the in vitro diagnostic market assembled to match.  At 21,300 attendees and nearly 800 exhibits, this was a record audience for AACC.  Exhibits and scientific sessions tackled some of the top concerns of the healthcare system including healthcare infections, opiod addition, results near-patient, gene editing, epidemics and other topics.  Kalorama had staff at the meeting and covered events.    In this article, we briefly review those products and trends.  For those seeking market information in detail on the IVD market, Kalorama has been covering the market for two decades.  Our main market study of the IVD market is The Worldwide Market for In Vitro Diagnostics.     The following developments were noted:

Opioid Addiction and IVD Testing

  According to a seminar held at AACC 2017, lab pathologists could play a critical role as 'physician consultant' when it comes to combating opioid abuse.  A new genetic test could potentially help stem the tide of the opioid epidemic by predicting which patients are at risk of abusing prescription opioids.   A team of researchers led by Sherman Chang, PhD, vice president of research and development at AutoGenomics, Inc. of Carlsbad California has found that 16 genetic mutations involved in brain reward pathways could potentially help identify patients at risk for addiction studies in scientific literature.  Another study by researchers at Prescient Medicine compared the frequency of identified mutations in 37 patients with prescription opioid or heroin addiction versus 30 age and gender matched individuals with no history of addiction.  The researchers also tested 138 additional patient samples with the genetic panel and algorithm.  From this, the test - called the Near score- was highly accurate, with a sensitivity of 97% and a specificity of 87%.

Thermo Fisher promoted its CEDIA Buprenorphine II Drugs of Abuse Assay.  The CEDIA Buprenorphine II assay is the only assay on the market that cross-reacts with all major metabolites minimizing the potential for false-negatives. The assay also has no significant cross-reactivity to other opioids including morphine and therefore, is suitable for testing urine samples from patients on slow-release morphine therapy.

 

CRISPR/ Cas9 

Gene editing was also a large focus at the meeting's first day.  Jennifer Doudna, PhD, a geneticist and a co-creator along with Emmanuelle Carpenter, PhD, of the CRISPR-Cas9 technology, delivered the Wallace H. Coulter Lectureship Award plenary on Sunday with her talk, “CRISPR Biology, Technology & Ethics: The Future of Genome Engineering.”   Doudna discussed her “molecular scalpel for genomes.” She intrigued the audience by reviewing the intricate bacterial CRISPR adaptive immune system and how her lab harnessed its power to edit genes.  She discussed the work that is ongoing aimed at making CRISPR more amenable to fighting disease.   CRISPR/Cas9 is a revolutionary approach that enables rapid, economical model generation through precise genome editing. Every day, new studies continue to leverage the potential of CRISPR to generate novel strategies for modeling diseases and assessing therapeutic intervention.  The tool is used in nature by bacteria to adapt to their environment.



Improving Influenza Detection

    In other news made at the meeting, researchers indicated they have discovered new methods that coul improve treatment for infectious diseases by enabling earlier detection of influenza outbreaks and   In an outbreak, earlier detection of influenza or any infectious disease activity could improve the ability of health agencies to respond appropriately.  Using data on test reimbursement from the CMS, a team led by Rex Astles, PhD, coordinator at the CDC Division of Laboratory Systems in Atlanta, investigated whether it was possible to detecting  influenza  outbreaks early.  The team designed an algorithm using Medicare outpatient claims from 2007-2012 to calculate predicted weekly volumes for flue tests and flue diagnoses increases in predicted volume that surpassed a certain standard deviation and that were followed by a similar drop in volume were categorized as influenza episodes.  The team compared detected flu episodes with those identified using positive rapid flu test volumes from the CDC National Respiratory and Enteric Virus Surveillance System (NREVSS)    The predictive models it was found, would have detected 64 (test model) and 60 (dx model) out of 67.  The test ordering model alone was slightly more predictive.  Such a prediction could be a signal that surveillance and testing of patient specimens to identify the strain could be initiated.  

Sepsis Testing, Acute Kidney Injury Testing, C. diff.

 The seriousness which the health care system is taking sepsis, a killer of 30 million Americans annual, was on display at the event with an increased focus on PCT testing.  PCT or procalcitonin test may be used, along with other tests and examinations, to help detect or rule out sepsis in a seriously ill person. It has primarily been used in people who seek care at emergency departments or who are admitted to intensive care units (ICUs) with signs and symptoms that may be due to sepsis.

  • Beckman Coulter announced PCT Results for their AU480/680/5800 chemistry analyzers. The company said the PCT assay offers laboratories the ability to provide sepsis testing through a simple chemistry menu addition.
  • Roche Diagnostics showcased its Elects BRAHMS PCT Assay which the company said was the only fully automated and integrated PCT solution in the United States.
  • Ortho Clinical Diagnostics announced a global sales partnership with BRAHMS GmbH, part of Thermo Fisher Scientific Inc., to develop the BRAHMS PCT (procalcitonin) assay for use on Ortho’s VITROS® Systems. The BRAHMS PCT assay is used in conjunction with other laboratory findings and clinical assessment to aid in several aspects of sepsis management. Ortho is currently developing the assay for use on Ortho’s VITROS® Immunodiagnostics and Integrated Systems for small-, mid- and high-volume clinical labs around the world.

  Sepsis was not the only disease tackled by vendors.    AKI, the sudden loss of kidney function, can develop without warning and potentially lead to kidney failure and death. The disease causes as many as two million deaths annually worldwide3. AKI is caused by renal stress contributed to by major surgery, drugs, toxins, serious infection, or chronic illness and trauma. Up to 50 percent of patients in intensive care develop some stage of AKI.  bioMerieux and BioPorto are among companies offering testing products in this area.  

  "AKI is where sepsis was 15 years ago," said Fernando Chaves, Ortho Clinical Diagnostics' global head of Clinical and Scientific Affairs, in an interview with Kalorama.  Chavez suggested most tests treat kidney disease too late, and that the testing for heart disease should be a model for AKI.    Testing is only as important as the results can get to the provider so as always  point of care (POC) systems was also an important focus.  Sekisui Diagnostics promoted its quantitative immunoassay product, its FastPack IP system, that the company says can take tests that once took days and perform them in 12 minutes.  Vitamin D, Testosterone, PSA, TSH and Alpha GST were among the tests on the system.  Roche continued to promote its cobas Liat, a PCR platform that is point of care and tests for flu, strep and RSV.  J Mitra and Company showcased its Advantage Malaria Card, a rapid visual antigen based test for detecting infection with P.falciparum (HRP-2) malaria parasite in whole blood, boasting results in 20 minutes. 

 Clostridium difficile (C. diff), a health care associated infection, was the target of IVD products from Luminex and Dia Sorin in different assay formats.  Vendor Ortho Clinical Diagnostics touted the establishment of its NephroCheck® test, on OCD's VITROS system, which the vendor said was the first fully automated risk assessment tool for predicting Acute Kidney Injury (AKI).    The test has received CE Mark clearance, signifying conformance to all EU regulations, and is now available for purchase and use on Ortho’s VITROS® Systems in Europe. 

 Novel and Improved Point of Care (POCT) Solutions

Near patient is always popular.  Get results to the patient’s bedside or the doctor’s office, and you’ll have a better physician consult and likely, a better outcome.  But the technology hasn’t always lived up to the promise.  Tests that take 60 or 90 minutes are getting outside the zone of being truly helpful – patients do not wish to wait in the doctor’s office for that period of time, and time is a factor in hospital care as well.    The goal of many products launched recently has been to reduce that time.  Kalorama Information covers Point of Care testing markets in its report Top 50 Companies in Point of Care Diagnostic Tests https://www.kaloramainformation.com/Companies-Point-Care-10828861/   Among the significant point of care developments:  Among many developments in POCT, Siemens Healthineers launched its Xprecia Stride Coagulation Analyzer.  The handheld testing fingerprick device has a large, intuitive touchscreen on the handle.   PT/INR testing is used for the monitoring of oral anticoagulation therapy (OAT) with warfarin.  The company says the unit provides lab accuracy and intergrates with EHR though Siemens-owned UniPOC Software. 

 

  •  The Spartan Cube, the world’s smallest DNA-testing device, is the fastest way to identify potential individuals for research studies based on their genetics. One-in-four people carry APOE genetic mutations that increase the risk of developing Alzheimer’s.  These genetic carriers can be ideal candidates for research, and the Cube can accelerate the identification of these individuals. For example, the Spartan Cube enables testing in doctors’ offices, walk-in clinics or even nursing homes. 

  • Orchard Software launched its Orchard Trellis, a POC testing information system that the company says simplifies the integration, administration, and management of point-of-care testing (POCT).   POCT results are integrated into the EHR, promoting fast access and making results available for population health management. Status of POCT sites (instruments, user certifications, QC, patient result statuses) can be quickly asessed via an information dashboard, and result evaluation rules functionality, Levey-Jennings QC graphs, and linearity reports are offered.

  • The epoc Blood Analysis system delivers blood gas and electrolyte results in about 30 seconds, according to the manufacturer.  Currently part of Alere, Siemens Healthineers recently announced its intention to buy the unit that owns epoc due to Alere's merger with Abbott.  Abbot's iStat blood gas POC system was also on display at the meeting.  

  • A palm sized dock and disposable assay speific test cassettes were a feature of Mesa Biotech's Accula System.  The San Diego-based company says its MDX-POC system will allow healthcare professionals to access actionable, laboratory-quality results at the POC in 30 minutes or less with greater sensitivity and specificity than many current infectious disease rapid immunodiagnostic tests. 

  • DiaSorin showcased the firm's Simplex C. difficile Direct Assay for marketing in the US.  The test runs on DiaSorin's Liaison MDX benchtop instrument, which provides clinically validated, real-time PCR results t about 15,000 C. difficile-related deaths occur in the US annually, and added that the bacteria is the most common microbial cause of US hospital-associated infections. The assay has been available outside the US since November.

  • Trinity Biotech promoted its Syphilis Health Check.  The company claims the product is the only CLIA waived rapid screening product for the disease. This product can be used as an initial screening test or in conjunction with a non-treponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. 

  • Sarstedt showcased its S-Monovette POC Collect Kit.  The system is an innovative, point of care collection system for venous sampling, designed to be easy to use but yet precise enough to avoid risking blood exposure.  

  • Roche Diagnostics CoaguCheck XS Plus System delivered CLIA-waived testing with enhanced connectivity.  Also on display was the company's cobas Liat,  an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus RNA in nasopharyngeal swab specimens  The test is intended for use as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV and is aimed at POLs and small clinics.

  • Alere Afinion's AS100 Analyzer can provide CLIA-Waived A1C results in 3 minutes and Albumin/Creatinine Ratio) results in 5 minutes.   The test is s used to screen people with chronic conditions, such as diabetes and high blood pressure (hypertension) that put them at an increased risk of developing kidney disease.

 

Antibiotic Use – the Role of IVD Testing in the Lab?  

Reducing antibiotic use in children.  Researchers from MeMed Diagnostics in Tirat Carmel Israel, evaluated the efficacy of their host-immune based ImmunoXpert assay in 233 pediatric patients who presented at the ER with fever.  To classify an infection as bacterial or viral, the assay measured the serum levels of three protein biomarkers: TRAIL, IP-10 and C-reactive protein.  The results were then compared to diagnoses made by a physician panel along with multiplex polymerase chain reaction.   ImmunoXpert correctly classified 90% of bacterial cases and 91% of viral cases.  The researchers said they received similar performance over a range of viruses and bacteria.  

Autism Testing

 Another session revealed research that could significantly improve treatment for Autism.   A team of researchers has demonstrated that children with autism spectrum disorder have  a unique composition of gut bacteria and urinary metabolites compared with unaffected children.   Although different forms of therapy can improve autism symptoms researchers have yet to uncover a comprehensive treatment solution.  It is difficult to diagnose before the second year of life.  An assay that detects autism earlier could lead to more effective therapeutic and medicinal interventions.  A research team led by Antonio Noto of the department of surgical sciences at the University of Cagliari in Cagliari, Italy set out to elucidate the role of metabolism and the gut microbiome in children with autism.  The team took samples from 21 autistic patients from 4-16 years old and 21 non-affected siblings from 4-17 years old.  Proton nuclear magnetic resonance spectroscopy was used to measure metabolites present.  and targeted sequencing was used to profile gut microorganisms.   The researchers found that urinary metabolites in autism spectrum disorder patients were markedly different from those in the non-affected siblings.  An imbalance in amino acid metabolism an increased levels of hippurate, glycine, creatine, tryptophan and D-threitol was detected, while decreased levels of glutamate, creatinine, lactate, valine, betaine and turine was detected.  An increased presence of Clostridium bacterial species was detected compared with the non-affected siblings.  The researchers believe this finding could suggest treatment and earlier intervention methods.  

   

 Middle East IVD Market

Long a target for IVD companies seeking emerging market growth, the Middle East will now have a laboratory association with global pull.  AACC announced on Monday that it will launch a new laboratory medicine conference and expedition next spring – AACC Middle East. AACC Middle East will showcase AACC’s globally-renowned education and scientific programs paired with a dynamic exposition in Abu Dhabi, United Arab Emirates (UAE), March 22-24, 2018. The scientific program will feature experts from the U.S. and the Middle East, sharing knowledge and innovation. Attendees will meet and network with experts in the field, and engage with their peers during the scientific program highlighting recent advances in laboratory medicine.  Kalorama's report on the Middle East IVD market can be found at https://www.kaloramainformation.com/IVD-Middle-East-10336235/.

 “Data Lakes” and Connected Labs

 Roche’s booth at AACC 2017 features a virtual reality tour that will demonstrate the company’s concept of connected lab . "The idea of a connected lab begins with an integrated core lab with connected automation.” said Jack Phillips, president and CEO of Roche Diagnostics Corporation in a press release.  “But it also involves linking instruments to data lakes, laboratories to physicians, and high-medical-value tests to clinical insights to help improve the way physicians manage their patients.”  A data lake is a storage repository that holds a vast amount of raw data in its native format and doesn't structure it and define how it will be structured, until the data is needed.  The company is the largest IVD company, according to Kalorama Information and competes in nearly every IVD sub market; while it is also demonstrating a new cobas e 801 high-volume immunoassay platform that Roche says provides nearly twice the throughput on the same footprint as its predecessor.

  

Infectious Disease Tests

 Diseases caused by infection are among the hardest challenges for healthcare, and require early and accurate detection for treatment to be optimized.  And according to IVD market researcher Kalorama Information, they are also among the largest and most competitive markets for IVD instruments, kits and reagents.   Kalorama Information noted the following developments : 

  • Clinical Chemistry Magazine's AACC 2017 issue focused on the Myanmar H1N1 flu outbreak, worse since 2009, which has claimed 10 lives, and also a new method for detecting 5 gram-negative bacteria using genoproteomic peptide marker analysis on a combined MS/LC system. 
  •   Ortho Clinical Diagnostics showcased the Vitros Immunodiagnostic Products human immunodeficiency virus (HIV) combo assay for use on the Vitros 3600 immunodiagnostic system.  In February, the company announced it had  submitted a premarket approval (PMA) application to FDA for the product. The company has also submitted PMA supplements for the Vitros HBeAg and Anti-HBe assays, for use on the Vitros 3600 immunodiagnostic system and Vitros 5600 integrated system. 

  •    New YFV Protein: Aalto Bio Reagents announced their first-to-market recombinant Yellow Fever Virus (YFV) protein at AACC in San Diego from 1st - 3rd August. Yellow Fever virus is a potentially fatal mosquito-borne flavivirus which is prevalent in tropical and subtropical locations in South America and Africa.  It is the next flavivirus threatening the population of Brazil, with local health officials reporting a sharp rise in cases this year.  The company, founded in 1978, Aalto Bio Reagents is a developer and provider of raw materials to the in- vitro diagnostics industry and to research laboratories globally.   Infectious disease is one of the most important markets for IVD, and Kalorama covers this extensively in its market study on this area.
  • Same Day Multiplex For TB, Sepsis, Meningitis, Others:  Seegene Inc. announced a  Random Access System.  The company says the system can provide order-to-report on the same day by simultaneously performing high multiplex real-time PCR testing on a single platform, regardless of specimen type or assays.  Rapid, accurate diagnosis and prompt treatment are especially critical for a successful treatment of infectious diseases such as tuberculosis, acute diarrhea, sepsis or meningitis.   The company said most existing MDx systems are unable to perform same-day reporting for same day treatment, because clinical laboratories typically perform testing after a sufficient number of specimens are collected. 

 All of Kalorama Information's diagnostic market research studies can be found here:  https://www.kaloramainformation.com/diagnostics-market-c1125/.