• by Bruce Carlson
  • February 6 2018
  • IVD


5 IVD Market Trends to Watch in 2018

5 IVD Market Trends to Watch in 2018

Based on our research in 2017 and early 2018, we see these five clinical testing trends.  as the most likely to see further development in 2018.  

Liquid Biopsy and Multi-Target Liquid Biopsy


Non-invasive cancer testing will continue to trend in 2018.  Qiagen has been pioneering the use of liquid biopsy-based companion diagnostics as a less-invasive option to complement surgical biopsies for genomic profiling of cancers. Qiagen is expanding its industry-leading portfolio of liquid biopsy solutions addressing all major technologies: cell free DNA, exosomal analytes and circulating tumor cells. Qiagen's leading portfolio of liquid biopsy technologies also includes the QIAamp Circulating Nucleic Acid Kit, which is considered to be the gold standard sample technology for the processing of free circulating DNA and RNA, as well as the REPLI-g product line, which enables genomic analysis from single cells.

PAXgene technology offers automated solutions for the collection, stabilization and purification of circulating cell-free DNA from blood samples. It allows whole blood to be drawn and stored at cooled and ambient temperatures for up to seven days before samples are processed and tested for the presence of circulating cell-free DNA.

More Information Can Be Found in Kalorama Information's Liquid Biopsy Markets

At the J.P. Morgan healthcare conference, Guardant Health CEO Helmy Eltoukhy said during the liquid biopsy company's presentation that it plans to submit to the US Food and Drug Administration a liquid biopsy assay, Guardant360IVD, by the end of 2018.   The firm has also developed a liquid biopsy assay that analyzes more than 500 genes, GuardantOMNI, which it launched in the second half of 2017 and which has so far seen "higher than anticipated demand."  GuardantOMNI is the firm's second product after Guardant360, a liquid biopsy assay it launched in 2014 that analyzes 73 genes. 


The Consumer Rules


In some cases, the consumer is seeking out testing directly. The global direct-to-consumer (DTC) genetic health testing market totaled $99 million in 2017, according to our most recent report. . With average 25.6% growth, the market will grow to $310 million in 2022. Kalorama Information said growth of the direct-to-consumer genetic testing market is born out of a paradigm shift among consumers who are seeking greater control over their own healthcare. Kalorama did not include paternity testing in its number. The finding was made in the firms report. The Market for Direct-to-Consumer Genetic Health Testing http://www.kaloramainformation.com/Direct-Consumer-Genetic-Health-Testing-11370673/.
Ethical dilemmas are also a concern for the industry. This involves the interpretation and use of the genetic test results. To address this concern, many DTC genetic testing companies have employed onsite genetic counselors. Because this is a fledgling industry, there will be a number of growing pains before this industry is mainstream.

A growing segment in clinical laboratory testing is as a service provided by walk-in style clinics in pharmacies and retail food outlets. Retail clinics, also known as convenience clinics, have become a quickly growing segment of the U.S. health care marketplace. Retail patient service centers have grown in number since they first came on the scene in the mid-2000s. In 2010, there were 1,200 retail clinics operating in 32 states in the U.S., according to the Convenient Care Association (www.ccaclinics.org). Accenture Consulting estimates the number of U.S. retail health clinics would reach more than 2,800 in 2017 (www.accenture.com/us-en/insight-retail-health-clinics).
In 2016, total U.S. retail clinic sales are estimated at more than $1.4 billion, an increase of 20.3% per year from $518 million in 2010. Through 2020, sales are expected to continue expanding (Kalorama Information: Retail Clinics 2017: The Game-Changer in Healthcare).

More information Can Be Found in Kalorama Information's Retail Clinics Report

With the Theranos (Palo Alto, CA) debacle in 2016, the allure of retail clinic ventures had faded somewhat. But, in 2017, various news reports indicate that Quest Diagnostics (Quest) and Laboratory Corporation of America (LabCorp) have become more active and have been opening more patient service centers in grocery stores and retail pharmacies. In 2017, Quest has announced plans to open patient services centers with several retailers, particularly in the states of Texas and Florida. Similarly, LabCorp disclosed an agreement with Walgreens Boots Alliance. Walgreens and LabCorp announced a collaboration through which LabCorp will develop and operate patient service centers within select Walgreens stores. The centers, which will be co-branded "LabCorp at Walgreens," will offer LabCorp patient services in a secure, comfortable environment for specimen collection, located near the pharmacy area inside the store. Tests on specimens collected at the Walgreens locations will be performed through LabCorp's network of primary and specialty laboratories.

Quest has been a leader in the movement for consumer empowerment in healthcare. The company has been a strong advocate of the effort to provide patients with direct access to lab testing through its Sonora Quest Laboratories joint venture. Nearly three million patients track and access their lab results and health data through its myQuest by Care360 patient portal and mobile app. Other consumer offerings include Blueprint for Wellness, a growing wellness business, and Blueprint for Athletes, a direct-to-consumer biomarker monitoring service for amateur and professional athletes.  June 2017, Quest and Wal-Mart Stores announced they will open retail clinics. They will launch with a select number of locations (approximately 15) in Wal-Mart stores in Florida and Texas by the end of 2017. These co-branded sites will initially provide laboratory test services. Over time, offerings are expected to expand to include other basic healthcare services. This is in addition to Quest’s collaboration with Safeway grocery stores.   Seven LabCorp at Walgreens locations will begin seeing patients in 2017, with five patient service centers in Denver and one in Morrisville, North Carolina expected to open later in 2017. The initial Walgreens sites will be in addition to LabCorp's approximately 1,750 existing patient service centers, providing even more options for patients to access LabCorp's menu of over 4,800 tests, including offerings in important areas such as women's health, genomics, oncology and companion diagnostics.


Skipping the Pathogen: Syndromic Testing


Infectious disease tests most companies produce detect a single pathogen, or an antibiotic resistance gene. However, if a patient presents with general symptoms of a respiratory infection, or with symptoms of a gastrointestinal infection or some other type of infection, there are several different pathogens that may have caused the infection. This has led to the development of syndromic panels that include a panel of pathogens and often also resistance genes commonly found with the targeted type of syndromic infection.

 Examples include:

  • BioFire Diagnostics (a bioMérieux company) has commercialized the FilmArray platform. Four syndromic panels are currently available: Respiratory Panel, Meningitis/Encephilitis (ME) Panel, Gastrointestinal (GI) Panel, and Blood Culture Identificaiton (BCID) panel. BioFire Diagnostics also offers the FilmArray® Respiratory Panel EZ on the FilmArray® EZ Configuration platform. This is a CLIA waived test designed for point-of-care settings.
  • Curetis currently has developed the Unyvero Platform. Unyvero cartridges are available for three applications: (1) Unyvero HPN Pneumonia Cartridge - 19 resistance markers and 20 pathogens, (2) Unyvero i60 ITI Cartridge - For implant and tissue infections; For detection of up to 102 analytes, and (3) Unyvero BCU Cartridge - For blood culture; For detection of up to 103 analytes. In addition, an intra-abdominal infection application is in development. In the United States,
  • Curetis has conducted clinical trials and submitted to the FDA, seeking clearance of the Unyvero Platform and Lower Respiratory Tract Infection (LRT) Application Cartridge
  • GenMark Diagnostics has developed the ePlex® System. A respiratory panel is currently available.
    In addition to the single disease tests, Luminex is developing tests on the company’s VERIGENE platform. Luminex showcased the VERIGENE Respiratory Pathogen’s Flex Test at the San Diego AACC Annual Meeting in 2017. Luminex has also developed two gastrointestinal infection tests.

Microbiome


The continuous search for the etiology of diseases as part of the body’s systemic response to change has led to a consideration of the gut microbiome as part of disease processes. While still in the early phase of development a number of companies have developed assays for the study of the microbiome and there is a proliferation of microbiome related therapeutics.

Bacteria in the gut, mouth and plaque (biofilms) have been implicated in a number of diseases including: diabetes, obesity, autoimmune, cancer, diarrhea, and mental disorders. Thousands of species of microbes—bacteria, viruses, fungi, and protozoa—inhabit every internal and external surface of the human body. The microbiome’s complicated relationship with its human host is increasingly considered crucial to health. Imbalances in the microbiome’s diverse microbial communities, which interact constantly with cells in the human body, may contribute to chronic health conditions, including diabetes, asthma and allergies, obesity and the metabolic syndrome, digestive disorders including irritable bowel syndrome (IBS), and autoimmune disorders like multiple sclerosis and rheumatoid arthritis.

Researchers also evaluated specific diseases associated with disturbances in the microbiome, including gastrointestinal diseases such as Crohn’s disease, ulcerative colitis, irritable bowel syndromes, and obesity, as well as urogenital conditions, those that involve the reproductive system, and skin diseases like eczema, psoriasis, and acne, diabetes, autoimmune disorder, acute diarrhea, cancer, mental disorder, and others.

The following are developments of significance:

  • May 2016, the U.S. Office of Science and Technology Policy (OSTP) announced the formation of a National Microbiome Initiative (NMI), a collaboration of government agencies and private companies to research microbiomes across different ecosystems. The NMI will launch with an investment of more than $121 million from various federal agencies for 2016 and 2017, including $20 million from the National Institutes of Health, $16 million from the National Science Foundation, $10 million from the Department of Energy, $12.5 million from the National Aeronautics and Space Administration, and more than $15.9 million from the Department of Agriculture.
  • The University of Pittsburgh Schools of the Health Sciences and the University of Pittsburgh Medical Center announced they are taking part in the NMI by collaborating on a joint venture dedicated to better understanding the human microbiome. The university’s Center for Medicine and the Microbiome will bring clinicians and researchers together to explore how the microbiome affects health and disease, and to find new therapies for diseases affected by the microbiome. The center will receive more than $5 million from the university’s Department of Medicine, UPMC, UPMC Enterprises, the Pitt School of Dental Medicine, and uBiome, a microbial genomics company based in San Francisco, CA.  
  • November 2016, Bio-Rad Laboratories announced a partnership with Genetic Analysis whereby Bio-Rad received commercialization rights in certain undisclosed territories for Genetic Analysis' CE-marked GA-map technology to detect microbial imbalances, also known as gut dysbiosis.


Merging, Mixing, Matching in IVD: Still the Rule


A number of totally disparate phenomena have come together to paint the IVD industry with a fresh and refreshing coat of paint. Human genome research is providing areas of expansion for molecular testing. Decreases in life science funding in the U.S. has encouraged companies active in this space to migrate their technologies for clinical applications. The result is the entry of companies such as Illumina, Thermo Fisher Scientific, PerkinElmer and Affymetrix (now part of Thermo Fisher Scientific) to the diagnostics market. They have tweaked their research products to accommodate the needs of clinical lab medicine. These companies have made investments to become “clinical” companies.
These companies join expansion activity into new market segments by companies already involved in the IVD industry. The following is a sample of the initiatives that selected companies have taken to expand their product portfolio, particularly in molecular testing.