New Clinical testing segments to watch out for in 2018

Multi-Target Liquid Biopsy, Genetic Health Testing, Syndromic Testing, Microbial Imbalances

Advancements in technology and clinical medicine will have significant influence on IVD market. Liquid biopsy-based companion diagnostics; direct-to-consumer (DTC) genetic health testing ; detecting microbial imbalances; Infectious disease pathogen DNA testing and a number of totally disparate phenomena have come together to shape the future IVD industry.

Based on the market research, Kalorama Information, a division of, has published a white paper titled 5 IVD Market Trends to Watch in 2018.


According to the white paper the following trends should be on the radar of all progressive IVD companies.

Liquid Biopsy and Multi-Target Liquid Biopsy

Non-invasive testing particularly for cancer diagnostics will continue to feature as one of the most promising trends of 2018. While companies like Qiagen are betting big on its industry-leading portfolio of liquid biopsy solutions addressing all major technologies; others are finding novel ways to automate the process. According to the Kalorama report, US based PAXgene technology now 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.

In India, MedGenome, a genomics based research and diagnostics company launched liquid biopsy based Oncotrack a non-invasive screening test in March 2017. The test developed entirely by MedGenome, is the only one to be validated in India and verified from samples of cancer patients from across the country. The test screens the samples by analysing cell-free DNA that is isolated from the patients’ blood.  Using high end sequencing technology, the screening process identifies specific gene mutations that are linked with Melanoma, Lung and Colon cancers. The test facilitates detection of mutation where there is difficulty of obtaining biopsy or in the event of a damaged biopsy material and non-availability of tissue biopsy. This offers Oncologists the power to look for actionable alterations in a patient’s treatment, management, without having to do an invasive biopsy or where biopsy is not an option.

Around the same time, CORE Diagnostics a clinical laboratory chain partnered with Silicon Valley-based CellMax Life to introduce CellMax Life’s genetic cancer risk test and ctDNA-based liquid biopsy throughout India. CellMax-LBx Liquid Biopsy: A non-invasive ctDNA blood test to improve cancer treatment management, monitoring treatment response, and screen for recurrence – in real time. This test analyzes a comprehensive profile of 73 genes from circulating tumor DNA (ctDNA). Circulating tumor DNA are small DNA fragments shed by the tumor. Tumor genes may mutate over time, either as the cancer grows, or the treatment suppresses the cancer.

Market for Direct-to-Consumer Genetic Health Testing

The global direct-to-consumer (DTC) genetic health testing market totaled $99 million in 2017, according to Kalorama Information. With average 25.6% growth, the market will grow to $310 million in 2022 which is a result of a paradigm shift among consumers who are seeking greater control over their own healthcare.

Recently the Indian personal genomics and molecular diagnostics company Mapmygenome India Ltd inked a pact with Waynesboro, VA based ThinkGenetic, a unique platform offering resources for patients on genetic conditions. ThinkGenetic regularly receives inquiries from users worldwide with their questions or concerns about living with genetic disorders. If appropriate for answering a question received from a user from India, ThinkGenetic will provide the user with a trusted referral to board certified genetic counselors at Mapmygenome.

Detecting microbial imbalances

The role of gut microbiome as part of disease processes is an idea worth exploring. On a similar note, researchers are studying imbalance in the normal microbiome environment in humans to link it to a number of diseases including: diabetes, obesity, autoimmune, cancer, diarrhea, and mental disorders. 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.

According to the Kalorama Information report, thousands of species of microbes—bacteria, viruses, fungi, and protozoa—inhabit every internal and external surface of the human body. “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,” noted the report. The report further said that researchers were studying 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 report asserted that a number of companies have developed assays for the study of the microbiome and there is a proliferation of microbiome related therapeutics, but these are still in the early phase of development.

Syndromic Testing

Accurate detection of pathogens and antibiotic resistance is of utmost importance while treating infections in patients. However, most companies produce tests to detect a single pathogen, or an antibiotic resistance gene. But what if a patient presents with general symptoms of an infection and the doctor could screen for a number of pathogens at once. According to Kalorama Information report syndromic panels are being developed in the wake of such infections which includes 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,

The FilmArray panel is available in India. Infections due to multidrug resistant (MDR) gram negative organisms particularly those producing extended spectrum β lactamases (ESBLs) are of major concern worldwide. A recent study from Department of Critical Care , Sir Ganga Ram Hospital found that classically ‘ Hospital ‘ strains of bacteria which were drug resistant with high mortality are now spreading in community too. The distinction between community-acquired and hospital-acquired infections is becoming increasingly blurred. The main reasons for this are…

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