Top 5 News Stories in IVD - February 2017

Top 5 News Stories in IVD - February 2017

Among the top news stories in IVD this month, Roche moves into the hematology market with a European product launch, new options come to market for prenatal and newborn screening, and the FDA approves the first commercial Zika test for whole blood samples. Also, scientists design a 1-cent lab-on-a-chip and evidence builds for the power of breath tests to detect a variety of diseases.   Kalorama's most recent IVD report is the Market for Molecular Diagnostics. 

Molecular market nears $7 Billion

The market for molecular diagnostic testing reached $6.7 billion, according to Kalorama Information in a newly released report.   The market is driven by the increasing threat of infectious disease and cancer and the development of new products.  Kalorama Information is a New York City-based publisher of healthcare market research information.  The firm recently published its seventh edition of its study on molecular diagnostics, The World Market for Molecular Diagnostics, 7th Edition.

Growth is in infectious disease.  Accuracy, speed make these technologies ideal for meeting what is a growing threat. Time to results for real-time PCR and isothermal amplification are crucial for several infectious disease testing applications including respiratory testing, hospital-acquired infections, bloodstream infections, and molecular point-of-care tests. Superior sensitivity and non-invasive sampling will make qPCR and next-generation sequencing the future methods of choice for cancer testing and prenatal screening. Despite competitive displacement in cytogenetics, new cancer tests and blood culture tests, in situ hybridization will retain application markets in cancer testing and comprise 47% of the total molecular diagnostics market for cancer in 2021.

 Roche enters the hematology market

Roche announced in late January the launch of the cobas m 551 hematology analyzer in countries accepting the CE Mark.

The analyzer uses digital cell imaging and morphology analysis to automate one of the few labor-intensive tasks left in hematology, the manual review of blood slides and differentials.

While traditional hematology analyzers count and differentiate blood cells by indirect methods such as electrical impedance or flow cytometry, the cobas m 551 analyzer examines cells directly. The instrument places a single layer of cells on a slide (requiring just 30 uL of blood), stains them and makes a digital image of each cell. Its Bloodhound technology then counts, analyzes morphology and classifies every cell in the viewing area, resulting in a complete blood count and five-part differential and reticulocyte count. Hematologists can look at digital images of each cell directly, in many cases making microscopy unnecessary.

When Roche unveiled the cobas m 551 in 2015, it was entering a lucrative market with few competitors. The leading company in digital cell imaging for clinical hematology, CellaVision, had achieved average annual growth of approximately 18% in North America from 2010 to 2015 with its DM1200 and DM9600 cell imaging systems.  With this release, Roche is poised to challenge not just CellaVision, but also top hematology instrument vendors such as Sysmex, Beckman Coulter, Siemens, and Abbott, because the Roche analyzer handles the entire core lab hematology workflow.

 Roche plans to file for FDA approval to bring the cobas m 551 to the United States at an unspecified future date, a spokesman said this week.

New options for newborn and prenatal screening

The FDA this month announced it would permit marketing of the SEEKER screening platform, manufactured by Baebies Inc. of Durham, North Carolina, for detecting of a group of rare inherited metabolic disorders in newborns.

 The system - an instrument and reagent kit - measures enzymes in a dried blood spot collected from the newborn’s heel. If it detects reduced levels of any of four enzymes responsible for eliminating waste from body cells, the baby may have a lysosomal storage disorder.

The four enzymes it detects correspond to four related disorders, Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher and Fabry. These disorders can cause organ damage, neurological disability or death if not detected and treated early.  While at least 10 states mandate newborn screening for lysosomal storage disorder, this is the first FDA-authorized device marketed specifically for this purpose.  Meanwhile, Illumina announced at the end of January that an updated version of its VeriSeq NIPT Analysis Software received a CE Mark and is available to clinical laboratories in the European Union.

Illumina’s noninvasive prenatal testing software analyzes sequencing data from cell-free fetal DNA isolated from a mother’s peripheral blood. It generates a score that can help detect an abnormal number of copies of chromosomes 21, 18, 13, X or Y, signs of Down syndrome or other birth defects.  The updated VeriSeq NIPT Analysis Software accommodates larger batches, 48 samples rather than 16.   Illumina is now working through the requirements for an FDA submission to bring the software to the United States, a spokeswoman said this week.

FDA authorizes first Zika test for whole blood

Abbott announced this month that its RealTime Zika assay has been authorized by the U.S. Food and Drug Administration for emergency use on whole blood samples, when collected alongside a patient-matched serum or plasma sample.

 While the Centers for Disease Control and Prevention's Trioplex Real-time RT-PCR assay can detect Zika in whole blood, Abbott’s RealTime Zika assay is the first commercial test FDA has authorized for this use.  Zika virus RNA can be detected in serum, plasma and urine during acute infection, up to 14 days following onset of symptoms. In whole blood, Zika virus RNA may be present for up to two months.

Scientists develop a lab-on-a chip costing only a penny

 A report in the Proceedings of the National Academy of Sciences released online Feb. 6 describes how Stanford University researchers made a lab-on-a-chip device that can be manufactured for only $0.01 using nanoparticles, microfluidics and an ink-jet printer.

 The device has two parts, a reusable electronic apparatus and a disposable biochip. Both parts can be manufactured simply, with software and a printer, and without the need for a clean room. Rather than labeling analytes, another labor-intensive manufacturing step, it uses electric fields to move cells and molecules. A device can be made in about 20 minutes.  The device can also be easily reconfigured to accommodate analytes of various sizes, from blood cells to bacteria to DNA molecules.

The authors envision the device as a way to provide point-of-care diagnosis for malaria, tuberculosis, cancer and HIV to developing and resource-poor nations, and also to improve access to diagnostics in the developed world.