Hematology is the study of peripheral blood and bone marrow cells in order to diagnose various diseases of the blood including leukemias, anemia and autoimmune diseases. Kalorama Information has covered hematology for decades in its report The Worldwide Market for In Vitro Diagnostic Tests https://kaloramainformation.com/product/the-world-market-for-in-vitro-diagnostic-tests-12th-edition/

The basis of hematology testing is the complete blood count (CBC) that provides information on blood components: hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, platelets. The CBC is run as part of the normal work up in an annual health exam and for every inpatient. A drop of blood is placed on a microscope slide and stained. The slide is then examined under a microscope and the cells are analyzed.

Hematology will remain the second-largest volume of global IVD procedures, with the number of tests increasing 5.3% per year to nearly 6.7 billion in 2024. Growth in related IVD product sales during the same timeframe will expand 5.5% annually to over $5.6 billion.

The menu of hematology tests includes: CBC + 5-Part Differential (or 3-part Differential), Manual Differential/Review, Hematocrit, Hemoglobin (Automated, Manual), Sedimentation Rate, Reticulocyte Count, white blood cell (WBC) count, platelet count and analysis, and red blood cell count (RBC).

There is continued discussion as to the need for a full 5-part differential versus a 3-part differential. White blood cells, or leukocytes, are the immune system’s primary defensive against infection and disease. Therefore, measuring the level of white blood cells in blood enables clinicians to easily detect and monitor various conditions.

The 3-part provides a count of WBC types: granulocytes, monocytes and lymphocytes. The 5-part provides a more advanced WBC count of neutrophils, lymphocytes, monocytes, eosinophils and basophils.

Each WBC serves a different function, which is why most laboratories prefer to count for all of them. Lymphocytes attack specific viruses and bacteria, neutrophils combat bacteria; eosinophils target parasites and certain infections; monocytes respond to inflammation and replenish white blood cells in bodily tissue; and basophils, the rarest type, attack certain parasites. All high-volume systems provide at least a 5-part and many smaller instruments do as well.

However, depending on the facility’s level of expertise and budget a 3-part differential may fulfill its need. In fact, vendors are still marketing 3-part instruments with sophisticated sample management enhancements.

Today and over the past 50 years, the CBC has made an enormous impact on patient care. A CBC is run on every hospitalized patient and it is a vital part of a yearly annual checkup. The information clinicians derive from the CBC is used in the evaluation of just about every medical condition.

Since the late 1990s hematology cell counting progressed from impedance-based technology (the basis of the Coulter Principle) by borrowing from flow cytometry. Incorporation of laser excitation and fluorescence detection into the hematology analyzer has grown the instruments’ cell discrimination abilities to include blood cell components that required labor intensive and inexact manual methods. This one significant addition also created automated flow cytometers for the hematology laboratory.

Hematology analyzer product differentiation is accomplished by adding new parameters to a basic instrument—such as platelet counting, reticulocyte counting and CD4/CD8 analysis. The second approach is expansion into body fluids other than blood. The third avenue for differentiation is in automation strategies that include integration onto a core lab automation track, the addition of an automated slide maker and stainer, cell imaging technology and bioinformatic software. These strategies have already been put in place by all of the players.

Thus, hematology vendors have perfected high-end hematology analyzers to perform a number of specialized tests that are now available on-demand and almost instantaneously. Using the cell staining and counting capabilities of high-end hematology analyzers allows labs to automate fluid analyses such as CSF. Abbott Diagnostics, Beckman Coulter/Danaher, Siemens Healthineers and Horiba offer specialized platelet, red blood cell and white blood cell analysis and automatic slide makers/stainers. This feature decreases the number of differential slides that have to be made to only those samples with really abnormal cells.

POC Professional Hematology Testing
The total worldwide volume of POC professional hematology testing procedures conducted is predicted to expand 4.4% annually to 424 million in 2024. Uses in general health screening and the diagnosis and monitoring of blood-related disorders during hospital stays, emergency room visits, and physicians’ consultations will account for growth. The availability of complete blood counts on high-throughput clinical chemistry systems will moderate a faster rise in procedure volume.
Hematology is the study of peripheral blood and bone marrow cells in order to diagnose various diseases of the blood including leukemias, anemia, and autoimmune diseases. The basis of hematology testing is the complete blood count (CBC) that provides information on the blood components hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, platelets. The CBC is performed as a component of annual physical examinations and pre-hospital admission testing. Samples that exhibit abnormal levels of any blood component undergo a microscopic examination of cell contents known as a blood cell differential procedure.

Other POC professional hematology procedures include hemoglobin and hematocrit, tests. Hemoglobin is a protein in red blood cells that carries oxygen to organs and tissues and transports carbon dioxide from organs and tissues back to the lungs. A low level of this substance is a symptom of anemia. An excessive level of hemoglobin indicates that the patient may be afflicted with the blood disorder polycythemia vera.
A hematocrit test measures the proportion of red blood cells in the blood. Red blood cells carry oxygen throughout the body. Deficiencies in these cells is associated with a number of conditions, including anemia, vitamin or mineral deficiencies, and blood loss. A higher than normal hematocrit ratio is manifest in patients with dehydration, polycythemia vera, and heart and lung diseases.

A number of hand-held and benchtop analyzers are available for POC professional hematology procedures. Among the producers of these products are Beckman Coulter, Diatron, GlysBy Diagnostics, HemoCue (Radiometer/Danaher), Horiba, Roche, and Sysmex.

Molecular vendors met in Baltimore at the Association for Molecular Pathology meeting in Baltimore Wednesday for pre-convention corporate workshops and presentations. Not surprisingly, some news was made. Several vendors presented new solutions to chip away at result times. Thermo Fisher Scientific launched its Ion Torrent Genexus System, an integrated next-generation sequencing (NGS) platform featuring an automated specimen-to-report workflow that delivers results in a single day.

The company said its turnkey solution makes it realistic in the future that local hospitals could adopt NGS testing. It’s common now for hospitals to use a single-gene test, or outsource their complex genomic profiling to a reference lab, and that can take several weeks and require larger sample inputs, Thermo says. Larger sample input can lead to more quantity not sufficient (QNS) reports, meaning results are inconclusive.

“We can envision a time when patients at local hospitals will have faster access to comprehensive test results that can guide more effective, targeted therapy selection and improved health outcomes.” said Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific.

Other developments include:

· Sequencing giant Illumina used the AMP meeting to announce the launch of TruSight™ Oncology 500 ctDNA (TSO 500 ctDNA), Illumina’s first liquid biopsy solution for detecting cancer biomarkers. The company said TruSIght provides labs the flexibility to analyze both tissue and liquid biopsy samples to uncover biomarkers using liquid biopsy where tissue samples are limited or unavailable, or to complement to tissue results by detecting biomarkers in circulating tumor DNA. The company also announced a high throughput system 500 Oncology High-Throughput, that can run up to 192 tissue samples on the NovaSeq 6000

· Carlsbad, CA-based ChromaCode, a target enrichment company announced the launch of its Multi-Drug Resistance (MDR) Panel. The system combines proprietary data science algorithms with widely-used, low-cost chemistries to enhance the multiplexing levels of common real-time and digital PCR instruments for detection of 5-50 targets in a single reaction. The company also detailed the performance of its HPDCR Tick-Borne Pathogen (TBP) Panel.

· Qiagen announced its simultaneous DNA/RNA Multimodal Panels, QIAseq, for comprehensive solid and liquid tumor profiling. The company said the product is the only solution to extract, enrich and sequence DNA variants and RNA fusions and assess gene expression in a single workflow from a single sample within a single day, where typically workflow is 2-3 days. The system uses an input as low as 10 ng of total nucleic acid, which conserves samples and reduces sample-induced bias present in other systems.

· Paragon Genomics announced several products including its CleanPlex® Hereditary Cancer Panel V2. The company said the product facilitates same-Day risk assessment of multiple hereditary cancers with reduced sample input, ease-of-use improvements and a 3-hour workflow. · Purigen Biosystems announced the launch of its small benchtop Ionic™ Purification System system, which utilizes the company’s core isotachophoresis (ITP) technology to extract, purify, and concentrate nucleic acids from biological samples in one hour with less than three minutes of hands-on time per sample.

· Menarini Silicon Biosystems debuted its new VRNxT™ volume reduction instrument for rare-cell and single-cell analysis. VRNxT removes manual pipetting steps. No specific skill sets or training are required for operation, thereby delivering user-independent results with high reproducibility and success, with 99% of single cells retained after volume reduction.

· Biocartis highlighted five opinion-leader studies that boosted its Idylla system, its real-time PCR based molecular diagnostics system. The company said the respective Idylla™ studies showed a strong performance of Idylla™ assays (RUO) compared to other methods including IHC2 and NGS3 in terms of concordance4, ease of use, workflow automation and turnaround times. For instance: Memorial Sloan Kettering Cancer Center researched the rapid assessment of EGFR, KRAS and BRAF mutations and MSI status on Idylla and found the system demonstrated excellent reproducibility as well as 100% concordance with reference methods, while a University of Alabama study concluded that the Idylla KRAS Mutation Assay could be an alternative method to rescue samples that appeared inadequate for a larger NGS-based panel, with the added benefit of a fast two-hour turnaround time.

· Asuragen highlighted user experiences with its new AmplideX® PCR/CE SMN1/2 Plus Kit for the quantification of SMN1 exon 7 copy number from whole blood and buccal samples. The company also featured its QuantideX® qPCR BCR-ABL IS Kit, QuantideX® qPCR BCR-ABL minor Kits and its NGS portfolio.

As molecular pathologists, pharmaceutical companies and in vitro diagnostic vendors gather in Baltimore MD for the upcoming Association for Molecular Pathology (AMP) in Baltimore, MD. corporate workshops have been announced.  The workshops indicate the direction the industry is going, with new molecular technologies such as mass spec and NGS replacing traditional ones in some cases.   Roche, Abbott Diagnostics, Qiagen, Thermo Fisher, Quidel, and Beckman Coulter are among IVD vendors that will exhibit at the meeting and run workshops and presentations.

The molecular diagnostics market is estimated at 8.7 billion, per our most recent report on molecular diagnostics:

Molecular pathology vendor workshops that have been announced include:

Next-Generation Sequencing:  News of the recent proposed expansion of Medicare coverage for next-generation sequencing testing should be good news for vendors.  (https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=296).  Many vendors will present on the topic – Qiagen will focus on the key bottle neck of clinical NGS test interpretation – with a seminar about reducing interpretation times by 85%.  Twist Bioscience will present: “Leading the Way in Target Enrichment.  Beckman Coulter Life Science will host “Implementation of Automated Comprehensive NGS Panel at a Community Cancer Center”  presented by Dr. Qi Wei, Assistant Professor Department of Biomedical Informatics at Vanderbilt University.

Other workshops related to NGS include Asuragen’s which will be highlighting its NGS-in-a-Box solution for DNA and RNA variants.  Arc Bio will focus on NGS-based metagenomics for micro labs; and Bio-Rad will be demonstrating orthogonal methods for validation and confirmation of NGS.   Archer Dx will focus on blood cancers.  The company’s panels can characterize  fusions, CNV and other variants. Karius will discuss its test which the company says can identify microbial-free DNA from plasma in patients with severe infection.

Mass Spectrometry: Agena Bioscience will feature “Low Cost, High Sensitivity: The Advantages of MALDI-TOF for Liquid Biopsy and Solid Tumor Profiling.”  The company’s MassARRAY system detects genetic variation directly by label-free mass spectrometry.  Its highly sensitive, multiplexed UltraSEEK technology, on the MassARRAY system can detect low levels of variants, which can be useful for analysis of somatic tumors.

SMN1/2:  Survival Motor Nueron protein is one of a group of proteins called the SMN complex, which is important for the maintenance of specialized nerve cells called motor neurons.   Many mutations in the SMN1 gene have been found to cause spinal muscular atrophy.  Asuragen will demonstrate  AmplideX PCR/CE SMN1/2 Plus Kit, which the company says offers rapid turnaround time, and automated results reporting software, the assay provides a simple and scalable SMN1 solution for all laboratories.

BCR-ABL monitoring:  Each year 1.0-1.5 newly diagnosed Chronic Myelogenous Leukemia (CML) patients are identified per 100,000 individuals.   CML prevalence is estimated to increase at an annual rate of 4%, and the number of individuals living with this disease will double by 2030.  CML is treated with a TKI called imatinib that targets the BCR-ABL fusion protein but assessing treatment efficacy for CML requires a molecular diagnostic.   Asuragen will demonstrate their FDA-cleared assay for highly sensitive BCR-ABL monitoring and Cepheid  will show its Xpert BCR-ABL Ultra test which automates the entire test process in one cartridge.

Liquid Biopsy: Roche will be demonstrating his Pan Liquid Biopsy Testing AVENIO ctDNA Clinical Research Story: Surveillance & Monitoring  All four mutation classes (SNVs, indels, fusions and CNVs) in a single DNA workflow with exceptional sensitivity and specificity.  Exactly-matched tissue and ctDNA panels (same genes, gene regions and hybrid-capture workflow) for true concordance.   The company says the test reports in 5 days.     Illumina’s new oncology menu for for NovaSeq 6000 System, which the company says offers high-throughput testing for liquid biopsy will be presented in another workshop, one of several hosted by the sequencing giant.

POC: Point of care has transitioned to molecular in the last five years; corporate workshops on this topic include Quidel’s on POC testing for influenza, and Roche’s look at centralization and decentralization trends in diagnostic testing.

Carbapenem Resistance: (CRE) or carbapenemase-producing Enterobacteriaceae (CPE) are Gram-negative bacteria that are resistant to the carbapenem class of antibiotics, considered the drugs of last resort for such infections. Meredian Bioscience will hosting a seminar on “Carbapenem Resistance Solutions for a Clear and Present Public Health Threat”    The company’s Revogene Carba C assay provides healthcare systems with a diagnostic solution to enable early detection and management of CRE.

LabPulse.com and Kalorama Information will be covering the meeting and providing highlights of important vendor and scientific announcements.

As molecular testing vendors meet this month in Baltimore for the Association for Molecular Pathology (AMP) 2019 meeting, market research firm Kalorama Information, specialist in in vitro diagnostics markets, estimates that tests aiding the detection and treatment of disease at the molecular level are the fastest-growing test category in all diagnostics. And the firm says the global market is estimated to be $8.7 billion in 2019.

This is according to the firm’s latest report, “The Worldwide Market for In Vitro Diagnostics Tests, 12th Edition.”  Kalorama Information’s report is based on a detailed study of corporate financials, medical journals and statistics, and vendor interviews.  The report comes out once a year.

To put that in perspective, Kalorama says the molecular diagnostics market is larger than the economies of many countries. For instance, the market exceeds the individual GDPs of the Kyrgyz Republic at 8 billion or Fiji at $5 billion, or the smallest independent GDP in the world, the tiny 9-island nation of Tuvalu at $48 millions.  More molecular diagnostic instruments and reagents will be sold this year than the GDP of Bermuda, Kosovo, and Sierra Leone, as well as those of 44 other nations, per World Bank statistics: https://databank.worldbank.org/data/download/GDP.pdf.

Why the popularity of molecular approaches? “It comes down to infectious disease,” said Bruce Carlson, publisher of Kalorama Information. “That’s been the primary sales area for molecular.  Molecular provides the speed and accuracy so that treatment can be initiated in a proper fashion for these conditions.”

Kalorama’s report says that infectious disease diagnostics represent the largest market within IVD accounting for about 51% of the global molecular diagnostics market.  Over 15 million office visits in the U.S. alone are for infectious disease-related cases, per CDC stats. (https://www.cdc.gov/nchs/fastats/infectious-disease.htm)  And the type of equipment and their applications keep growing, meaning more sales and higher pricing.

“Molecular used to be confined to the lab, but now you can see molecular testing for flu or Strep at a CVS or Walgreens, with minimal operator experience needed.” said Carlson.

Molecular diagnostics will move beyond infectious disease in the future, according to Kalorama’s report.  Cancer pathology is a major application area.   Other growth segments carrier tests, and transplant diagnostics. A detailed analysis of each of these application segments is presented in the respective segment in Kalorama’s report.

Major vendors include Roche, Danaher, Abbott, Bio-Rad, bioMerieux, Thermo Fisher, and others.

—–

Country data for perspective only.  Kalorama notes the following: Molecular Diagnostics Market 8.7 billion Kyrgyz Republic (8 billion), Kosovo (7.9 billion), Tajikistan (7.5 billion), Malawi (7 billion), Isle of Man (6.5 billion) Monaco (6.4 billion), Liechtenstein (6.2 billion), Guam (5.8 billion), Fiji (5.5 billion), Montenegro (5.4 billion), Mauritania (5.3 billion), Togo (5.3 billion), Maldives (5.2 billion), Somalia (4.7 billion), Eswatini (4.7 billion), Barbados (4.6 billion), Sierra Leone (4.0 billion), Guyana (3.6 billion), Cayman Islands (3.5 billion), Suriname (3.4 billion), Liberia (3.2 billion), Andorra (3.2 billion), Curaçao (3.1 billion), Burundi (3.0 billion), South Sudan (3.0 billion), Lesotho (2.7 billion), Greenland (2.7 billion), Aruba (2.7 billion), Faroe Islands (2.6 billion), Timor-Leste (2.5 billion), Bhutan (2.5 billion), Central African Republic (2.3 billion), Cabo Verde (1.9 billion), Djibouti (1.9 billion), Belize (1.9 billion) St. Lucia (1.8 billion), San Marino (1.6 billion), Gambia(1.6 billion), Antigua and Barbuda (1.6 billion), Northern Mariana Islands (1.5 billion), Seychelles (1.5 billion), Guinea-Bissau (1.4 billion), Grenada (1.2 billion), Comoros (1.2 billion), St. Kitts and Nevis (1.0 billion), Turks and Caicos Islands (1.0 billion), Vanuatu (.88 billion), Samoa (.86 billion)  St. Vincent and the Grenadines (.81 billion), American Samoa (.63 billion), Dominica (.5 billion), Tonga (.45 billion) São Tomé and Principe (.422 billion), Micronesia, Fed. Sts. (.345 billion)

 

Kalorama Information, along with representatives from parent company Science and Medicine Group, will be present at the Association for Molecular Pathology (AMP) meeting in Baltimore Maryland.  We will be covering the meeting for Lab Pulse.com, Kalorama Information and Instrument Business Outlook.

Seminars of particular interest to Kalorama Information:

  • Practical Approaches to Centralizing (or Decentralizing) Molecular Testing

  • CRISPR-CAS: Sessions including “Getting More from your MiSeq with DASH and FLASH” and “Assessing Unintended Off-Target Mutations”  

  • NIPT Requires Greater Oversight and Regulation, According to NDC Report

  • Picking a LIMS System

  • DNA Methylation and Machine Learning in Molecular Pathology for Diagnosis and Clinical Management

  • Liquid Biopsy in Infection & Cancer

  • The Future of the AMP v. Myriad Decision: Exploring Potential Impacts on Multigene Panel Testing and Patient Care
  • Medscape’s Expert Insights into Identifying and Treating TRK Fusion Solid Tumors in Adults and Children

Things we’ll be looking out for at AMP:

Guidelines on Companion Dx: We’ll listen for further discussion and new commentary on the use of evidence-based guidelines for pharmacogenomic tests. Last month, AMP opined that pharmacogenomic tests in clinical practice should be accessible for all healthcare providers, regardless of whether they have training in medical genetics or pharmacogenomics, and that reports should include the interpretation of the findings, significance of the results and limitations of the test. Pharmacogenomic information is already included in the prescribing information of hundreds of drugs approved by the U.S. Food and Drug Administration (FDA). Tests must have a well-established clinical validity. Read more in LabPulse.com: https://www.labpulse.com/index.aspx?sec=sup&sub=ivd&pag=dis&ItemID=800340.

NGS Sample Prep: Next-generation sequencing sample prep generated $1.8 billion in revenue in 2018 according to a report from Kalorama partner SDI. Sample prep encompasses nucleic acid extraction from biological materials, fragmentation of nucleic acids into smaller pieces and the preparation of sequencing libraries. We expect new product and product modification announcements. Beckman Coulter, Illumina and Fluidigm are among companies in this market.  nRichDX will be showcasing its a high-yield sample prep platform called Revolution System in Booth #2655.

Molecular Diagnostic Innovations: Nanostring‘s (booth 2933) nCounter Analysis System offers a cost-effective way to easily profile hundreds of gene transcripts, copy number variations, or miRNAs simultaneously with high sensitivity and precision. The system is comprised of a fully automated prep station, a digital analyzer, the CodeSet (barcodes) and all of the reagents and consumables needed to perform the analysis. The system has been designed to be easy to use and features a step-by-step guide to perform the analysis on a touch screen. The company will provide a technical update on the utility of the Hyb & Seq platform in clinical applications at the meeting, per a recent earnings call.   NeuMoDx will display its 96 Molecular System (2859) which the company says is capable of automated extraction and isolation of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. Arc Bio (booth 2951) will demonstrate its assay, the Galileo™ Transplant, which provides a turn-key workflow that enables end-users to easily introduce metagenomic NGS methods into their laboratory. The company says Transplant allows simultaneous detection and quantification of 397 viral strains from a single sample with next day results. Promega (booth #3035) will be providing solutions for use in molecular research, including presentations on past, present and future advances in testing for cancers exhibiting microsatellite instability (MSI) and screening for mismatch repair deficiency in the era of immunotherapy. The company will also present a workshop on the validation of a Novel Diagnostic Test for NASH.  Agena Biosciences (booth 3023) will exhibit at the meeting; the company offers both MassARRAY products and services.  The company’s products include the MassARRAY System plus ready-made panels that include blood typing panels, cancer panels, cystic fibrosis panel, pharmacogenetic panels, and sample identification and qualification panels, and custom panels.  Perkin Elmer  will also exhibit; its LabChipGX Touch nucleic acid analyzer provides complete analysis of genomic material in about 30 seconds, which the company says eliminates the nucleic acid quantitation workflow bottleneck.

Illumina workshops and Illumina-Qiagen Deal: The sequencing giant will host several workshops at the meeting, indicative of the company’s strategic direction, including:  New Oncology Menu: Enhanced Capabilities to Enable Comprehensive Genomic Profiling; Stakeholders Perspectives on Molecular Medicine: A Panel Discussion; Comprehensive Genomic Profiling Is Becoming a New Standard of Care in Oncology; and Enabling Comprehensive Genomic Profiling from FFPE & Liquid Biopsy Samples on a Single High-Throughput Sequencing Platform. We’ll look out for any additional information on the recent strategic partnership with Qiagen. (Recently, Qiagen and Illumina signed a 15-year strategic partnership on IVD tests that will take advantage of their respective strengths in companion diagnostics and sequencing systems.)

DTC: We’ll be on the lookout for any discussion of policy around direct-to-consumer testing: Earlier in the year AMP urged the FDA to halt its recent crackdown on laboratory developed tests (LDTs) and other pharmacogenomics (PGx) tests that reference specific drugs or drug classes unless approved by the agency.

Awards: Per LabPulse.com (https://www.labpulse.com/index.aspx?sec=sup&sub=gen&pag=dis&ItemID=800383), AMP will honor the following recipients of awards in molecular diagnostics:

  • Russell Higuchi, PhD, an R&D fellow at Cepheid, has won the Award for Excellence in Molecular Diagnostics. Higuchi is a molecular biologist who invented the first method and instrument patents for real-time polymerase chain reaction (PCR), the AMP noted in a statement. He also wrote the first papers on ancient DNA and the use of PCR in forensic science. Higuchi is a former executive of Roche Molecular Systems. He is set to deliver a keynote lecture on the use of DNA at the AMP meeting.
  • Karl Voelkerding, medical director of genomics and bioinformatics at ARUP Laboratories and professor of pathology at the University of Utah, has won the Jeffrey A. Kant Leadership Award. Voelkerding is being recognized for educational and practical leadership at the AMP. His positions with the organization include past president and program chair of the organization’s Infectious Diseases Subdivision.
  • Rami Mahfouz, professor of pathology and laboratory medicine at the American University of Beirut, has won the AMP Meritorious Service Award. Mahfouz was a key driver in the development and launch of the International Affairs Working Group, now called the International Affairs Committee, at the AMP. Mahfouz is being recognized for developing ties with organizations internationally and increasing the number of international attendees at meetings.

To set up an appointment to speak with the Kalorama team at AMP this year, please contact bruce.carlson@kaloramainformation.com.

 

 

The global volume of in vitro diagnostic (IVD) procedures has reached over 68 billion and is forecast to increase 3.4% annually to 81.0 billion in 2024, according to Kalorama’s new report on procedure volumes. These statistics are important for business planning, particularly for new products. The same timeframe will see worldwide sales of IVD products expanding 4.3% per year to over $85.2 billion.

IVD Procedure Volumes, 2019 and 2024

The United States will account for the largest volume of IVD procedures implemented worldwide. The U.S. will maintain a high, diverse level of tests based on its advanced medical delivery system, high healthcare spending intensity, and widespread health insurance coverage of the population. Moreover, its volume of IVD procedures will rise as patient care strategies place an increasing emphasis on early disease detection.

Per capita IVD procedures will remain high in Australia, Canada, Western Europe, Japan, South Korea, and other developed economies based on advanced, widely accessible medical communities and the universal or near universal coverage of residents for medical benefits. However, in most countries, the pursuit of stricter cost containment strategies by government health insurance plans will moderate overall growth in patient testing volume.

The volume of IVD procedures will rise at a fast pace throughout the developing world as countries upgrade and expand medical delivery systems. Reflecting population size and improving availability and accessibility of healthcare services, China and India will perform the largest number of tests. Because of cost constraints and imbalances in healthcare resources, IVD procedures in the developing countries will remain concentrated in basic assays and health screens.

Kalorama’s report provides information on several different segments of the in vitro diagnostics market. Kalorama’s report can be found at: https://kaloramainformation.com/product/ivd-test-procedure-volumes-2019-2024/

This is a positive development for next-generation sequencing’s clinical future, not only in diagnostic assessment of disease but also in therapy selection. But this is still about future development, and we’ll watch the products that the collaboration produces. We’ll also watch what the competition does — partnerships oft beget other partnerships.”

KALORAMA as quoted in Lab Pulse.com

October 8, 2019 — Qiagen and Illumina have signed a 15-year strategic partnership on IVD tests that will take advantage of their respective strengths in companion diagnostics and sequencing systems. The news came as Qiagen reported disappointing preliminary earnings for the third quarter and the departure of longtime CEO Peer Schatz.

Per the deal, announced on October 7, Qiagen gets nonexclusive rights to develop and commercialize IVD kits with Illumina’s MiSeqDx and NextSeq 550Dx systems. Qiagen may also expand the agreement to include new diagnostic systems developed by Illumina. Furthermore, the partnership may involve the development of companion diagnostics for Illumina’s TruSight Oncology genomic profiling assays for immunotherapy.

In a statement, the companies said the partnership will broaden the use of and patient access to IVD kits based on next-generation sequencing (NGS), including companion diagnostics. While the partners aim to start with oncology IVD kits, they envision expanding the collaboration to a range of other therapeutic areas, including cardiology and infectious disease.

The partnership makes sense given that Qiagen has been successful in developing companion diagnostics and is the key to relationships with pharmaceutical companies, while Illumina leads in sequencing systems, commented Bruce Carlson, publisher of market research firm Kalorama Information, a sister company of LabPulse.com. Not even the large companies can do it alone in today’s diagnostic world due to the complexity of molecular approaches, he added.

“This is a positive development for next-generation sequencing’s clinical future, not only in diagnostic assessment of disease but also in therapy selection,” Carlson said. “But this is still about future development, and we’ll watch the products that the collaboration produces. We’ll also watch what the competition does — partnerships oft beget other partnerships.”

Sales fall short, CEO steps down

The alliance with Illumina is one of a number of shake-ups at Qiagen. On October 7, the company announced disappointing preliminary sales results for the third quarter.

“For the third quarter of 2019, Qiagen currently expects preliminary total net sales growth of about 3% at constant exchange rates (CER) compared to the outlook for about 4-5% CER growth, and mainly due to significantly weaker-than-expected developments in China,” the company said in a statement.

Qiagen said it will focus development on the collaboration with Illumina and expand its portfolio of next-generation sequencing consumables that may be used with any sequencer. The company will discontinue its own development of NGS instruments, but it will continue to provide customer support for its GeneReader NGS system for smaller gene panels. Qiagen is also overhauling its manufacturing organization, resulting in a restructuring charge for the third quarter.

Also on October 7, Qiagen announced that Peer Schatz resigned from his position as CEO and chairman of the management board after 27 years with the company, though he will continue to serve in an advisory capacity. In a statement, Schatz said he is looking forward to new opportunities and challenges outside of Qiagen.

The company’s head of molecular diagnostics, Thierry Bernard, is stepping up to the role of interim CEO and will work jointly with Roland Sackers, Qiagen’s chief financial officer. Meanwhile, the company will look for someone to fill the role permanently.

Announcing a new product from Kalorama Information, Part of the Science and Medicine Group.  The  Kalorama Clinical Masterfile.

For the best business results, clinical diagnostics marketers need knowledge about several elements:

  • What products do my customers currently have?
  • What types of products? Clinical Chemistry, Micro, Molecular, Immunoassays, Hematology?
  • How old are those systems?  Is it likely they would seek replacement?
  • How is my competition doing?
  • How can I verify customer data that my sales staff provides?
  • What is their budget?
  • Who is in charge of buying these systems?

The Kalorama Clinical Masterfile is designed to help answer these questions.  It is the most comprehensive database of the installed base of clinical laboratory equipment in the U.S.  It is based on an ongoing survey of more than 5,300 facilities continuously updates data on more than 41,000 analyzers including manufacturer, model, number installed, year installed and department location.

The information is continuously gathered by phone and online reporting system with pathologists and lab managers at U.S. CLIA labs.  Every major modality is covered including chemistry, coagulation, hematology, immunoassay, integrated systems, microbiology, and molecular diagnostics.

The Masterfile is based on an ongoing survey of more than 5,300 facilities continuously updates data on more than 41,000 analyzers including manufacturer, model, number installed, year installed and department location.

Key demographics such as address, population served, budget and points-of-contact. The product is sold on a 12 month license, with quarterly updates included.  More information is available at: https://kaloramainformation.com/kalorama-clinical-masterfiledefinitive-information-on-u-s-clinical-diagnostics-instruments/

Each facility’s record in the MasterFile contains: 
  • 1. Facility Information
    IMV Master ID, AHA (American Hospital Association) ID, Medicare Provider (CMS) ID, Facility Name, Facility Address, Facility Phone Number (General),    Last Interview Date
  • 2. Key Demographics
    Population Served, Healthcare Spend (specific to Laboratory) ($), Spend Index
  • 3. Modalities / Areas CoveredChemistry, Coagulation, Hematology, Immunoassay, Integrated Systems, Microbiology, Molecular Diagnostics
  • 4. Installed Equipment
    Manufacturer, Model + Name / Number, Year Installed
    Department Location
  • 5. Contact Fields
    Name, Title, Institution ID (note that Client ID number can be added, if applicable)

See a Demo and Discuss the Clinical Masterfile:  

 Jonathan S. West
Business Development Director
Office: 1-703-778-3080 x 33
Mobile: 305.281.4720

Kalorama Information, a part of Science and Medicine Group, has announced that it has published its 25th report since the acquisition of the company by Science and Medicine Group. Since November, the firm has reported on food safety testing, infectious disease, Latin American Markets, molecular diagnostics and many other markets.

“Experts in sequencing, liquid biopsy, mass spectrometry are now available to us, as is an extensive network of clinical instrument placements and survey capabilities that can provide insights.”

Science and Medicine Group (then called Bioinformatics, Inc.) purchased Kalorama Information on November 1st, 2018. Previously the division was owned by MarketResearch.com

“Kalorama Information has been enhanced by the synergies present in an environment with healthcare and test instrument publishing partners,” said Bruce Carlson, Publisher of Kalorama Information and Senior Vice President of Publications for Science and Medicine Group. “Experts in sequencing, liquid biopsy, mass spectrometry are now available to us, as is an extensive network of clinical instrument placements and survey capabilities that can provide insights.”

Upcoming reports include a complete survey of laboratories using sequencing conducted by an expert with 2 decades of experience in biotech market research, a survey of clinical diagnostics customers relating customer experience and preferences. In August, the firm will publish its 12th Edition of the World Market for In Vitro Diagnostics.

“Our reports are quite different from the factory market research publishers that publish on cars this week, healthcare next week. Kalorama are based on real industry knowledge, experts put to the task, a focus on vendor actions versus academic modeling of industries.”

Kalorama’s website is available at www.kaloramainformation.com

As reported on LabPulse.com (Sign up at http:www.labpulse.com)

— Providers of proficiency testing for CLIA tests are becoming increasingly concerned about the lack of external quality control and oversight of CLIA-waived test kits, as the number of waived kits continues to expand. Some 1,400 waived test kits are now on the market, compared with 30 three decades ago.

Test kits that are waived from CLIA oversight are considered to be straightforward enough that they may be performed easily. But sometimes procedural mistakes occur when untrained clinical lab personnel work without the benefit of external quality assurance testing, and errors may not get picked up until the damage has been done.

Nearly three decades have passed since the U.S. Centers for Medicare and Medicaid Services (CMS) last updated CLIA regulations. Back then, only nine test methodologies, or test kits, were waived, but today, more than 1,400 test kits have been waived. Some test methodologies have become more complex and sophisticated over the years, but CLIA program regulations, which have not been updated for many years, have not taken into account newer test methodologies.

A test, or analyte, itself is not waived, but a methodology or test kit can be waived for CLIA oversight by the U.S. Food and Drug Administration (FDA). In February, CMS proposed adding 29 new analytes and deleting some existing tests in updated CLIA proficiency testing rules. Comments for the proposed changes are due on June 4.

While the proposed update addresses analyte regulation, it does not address waived test kits, which concerns proficiency testing organizations. Test kits are CLIA-waived because they are minimally technical. They use methodologies that are so simple and accurate that the likelihood of erroneous results is negligible. They use unprocessed specimens — whole blood or oral fluid — and pose no reasonable risk of harm to the patient if performed incorrectly. Some have been cleared by the FDA for home use.

Always room for error

“Waived testing is considered to be straightforward and uncomplicated enough that it may be performed by anyone able to read and follow the instructions on the testing kit’s package insert,” explained Christine Myers, senior associate with the medical lab evaluation program at the American College of Physicians, which offers a CMS-approved proficiency testing program.

“There are times, however, that procedural mistakes will happen when untrained personnel are running clinical laboratory tests without the benefit of external quality assurance testing, such as proficiency testing,” Myers said. “These errors can go on indefinitely unless something brings these mistakes to light, and this is usually only after a patient’s health has been negatively affected.”

For example, she noted that errors could lead to the misdiagnosis of an infectious disease or an unneeded increase or decrease in medication amounts to control glucose levels, based on flawed glucometer or hemoglobin A1c results.

“These types of errors may be caught when a laboratory participates in proficiency testing because testing compares test kit results against other labs using the same or similar testing methods,” Myers explained.

The main concern of proficiency testers is that without some type of external quality assurance testing, errors can go undetected for days or weeks before a serious situation brings problems to light. Moreover, two years or more can lapse between outside inspections of a laboratory performing waived testing in-house. If a lab is only doing waived testing, it may never be inspected by an outside agency — decisions on a patient’s diagnosis and treatment might be made based on flawed testing, and negative outcomes would result.

Alternatives to proficiency testing

Waived test kits can be submitted for proficiency testing. However, if proficiency testing is not a financial option for a lab, then the lab might consider performing split testing, in which a select number of patients are tested in-house and a duplicate sample is sent for testing at a reference or neighboring lab that participates and is successful with its own proficiency testing program, Myers explained. This would require additional work on the waived lab’s part as it would need to ensure that the testing is performed by a CLIA-licensed lab using the same or similar methods.

“The overall point is to offer quality tests and test kits with results that keep patients safe.”

— Christine Schimpf, American Academy of Family Physicians

Waived testing was supposed to include methodologies that were so simple that they would render reliable results, even if tested by people with no formal laboratory training, said Christine Schimpf, manager of proficiency testing at the American Academy of Family Physicians (AAFP). But the issue is that the methodologies have become more complicated — labs have quality control as well as checks and balances in place so that they do not get erroneous results, but errors still do occur, Myers said.

For example, many problems occur when test performers take shortcuts or don’t perform the test according to the manufacturer instructions, and they end up with results that are not as reliable as they should be, Myers added.

AAFP’s Proficiency Testing Program has client laboratories that use only waived test kits. Yet these labs enroll and participate in proficiency testing so that they would know how well the test kits and the labs’ staff have been performing. Schimpf is concerned that certain waived tests are not regulated and that incorrect results could affect patient safety. Waived test kits do not require daily quality control. These kits and tests only require quality control and oversight on each new lot of material or each time a new test kit is opened.

“Everything in the test kit is supposed to be in good shape. But problems could occur if a box of kits is left in the sun or if they are placed in a freezer by accident and they’re frozen,” she said, explaining that all these possibilities are in play. “You wouldn’t think that people would make those mistakes. But they do happen,” Schimpf noted.

Other problems occur when test results are incorrectly interpreted or when results are incorrectly entered into the patient’s report. Schimpf also expressed concerns that the proposed CMS rule does not address waived test kits, only regulated analytes.

“The overall point is to offer quality tests and test kits with results that keep patients safe,” Schimpf said.