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Automated molecular platforms: 3 companies on what’s new and next

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October 2018—CAP TODAY’s updated guide to the automated molecular platform market begins on page 45. Thirty-four platforms are profiled, with one new one: Hologic’s Panther Fusion. Writer Valerie Neff Newitt talked with three of the 20 companies about what they introduced this year, what’s to come, and more. “This is a dynamic and competitive industry. We are always asked to go faster, and that is what we are trying to do in terms of development,” says Michelle Tabb, PhD, chief scientific officer, DiaSorin Molecular. Others seem to be doing the same.

What did your company introduce this year, and/or what can we expect to see from your company in 2019?
Bryan Moore, PhD, director of marketing, molecular diagnostics, Roche Diagnostics: We introduced contamination-proof, validated preanalytics in three versions (Cobas p 312, p 512, and p 612), with differing amounts of “horsepower,” now approved to be used upstream of molecular testing and even to be physically connected to our Cobas 6800 or 8800 system. Molecular has to handle a lot of sample types—swabs, urines, bronchoalveolar lavages, blood, and serum. Bringing automation into the lab to handle those and route them onto analyzers will be transformative for molecular labs.

In addition to having introduced a number of assays and reagents this year, we launched the Omni utility channel on the fully automated Cobas 6800 and 8800 systems. The Omni channel takes all the core reagents from our in vitro diagnostics, except primers and probes that a lab adds, into the cassette. Laboratory-developed tests can then be run in parallel on the same system as IVDs. Operationally this brings an incredible amount of automation to an LDT workflow on the same instrument on which routine molecular diagnostics are performed. This is a new approach to LDT testing, one that reduces manual steps.

We also introduced the next generation of our MagnaPure 24 system to automate the DNA or RNA extraction from various samples—tissue, blood, serum—for downstream lab-developed test applications.

On the software side, we have had continuous updates and improvements in connectivity. Labs want instruments to connect to their LIS and EMR, so they can pull patient information, set up work orders, and deliver results seamlessly, without manually transferring or typing anything in. Five years ago connectivity was still relatively new to molecular, but now every one of our Cobas 6800 and 8800 instruments is going into a connected system.

Wade Stevenson, senior vice president of global marketing, BioFire: For this year, we have submitted a pneumonia panel to the FDA that is under review. We are optimistic for a Q4 launch. Right now, the most common way to test for pneumonia can be slow and laborious. Our syndromic panel uses cutting-edge molecular biology to test for 26 common bacteria and viruses associated with pneumonia—18 bacteria, eight viruses—and seven antibiotic resistance markers. Having the resistance markers for pneumonia is unusual; we will be the first to offer that.

What makes the panel even better is that lab hands-on time is minimal. Sample prep and run setup time are down to about two minutes. The entire run takes about one hour. It will be game changing.

We expect this panel will have a huge impact on how lower respiratory tract infections are diagnosed and will change the way antibiotics are prescribed and how patients are managed. Because we can combine the most probable pathogens associated with a syndrome in a cost-effective manner, doctors won’t have to order a test for just one pathogen; instead they can order a test for that entire syndrome.

Michelle Tabb, PhD, chief scientific officer, DiaSorin Molecular: Within the past year we launched Simplexa HSV 1 and 2 Direct with expanded claims—the only FDA-cleared HSV molecular test for cerebrospinal fluid and claims for all swab types, cutaneous and mucocutaneous. It is the most comprehensive coverage for molecular HSV testing on the market. Labs receive swabs from different body sites, cutaneous and mucocutaneous—wherever you could get a herpes lesion. Now clinical studies have shown that our product works beautifully for all those swab types. We also have claims for all of the common transport media types that swabs show up in, so there are not a lot of limitations for the lab. Our customers wanted it, so we did it.

In 2019 we will launch an FDA-cleared product for detection of varicella zoster virus, which causes chickenpox and shingles. Shingles lesions can look a lot like HSV lesions. The VZV product will have the same kinds of sample claims as our HSV product (CSF as well as cutaneous and mucocutaneous swabs). We designed these products for use on a disk that runs up to eight samples at a time. If a lab gets an order to test both HSV and VZV, they can be run at the same time and on the same disk.

This year we attained CE marking for Simplexa Bordetella Direct. We expect to launch that with FDA clearance in the U.S. in 2019, along with the Simplexa Group B Strep Direct, if all goes as anticipated.

Because our system has user-defined, or open mode, it allows customers to develop LDTs. Toward that end, we offer a huge menu of primer pairs and have launched several new primer pairs this year. The first is Pneumocystis jirovecii, important because it is hard to culture this organism and it is a cause of pneumonia, especially in immune-compromised patients. Second, we have expanded our tick-borne bacterial detection offerings to include primer pairs for Anaplasma, Ehrlichia, and Babesia. We have seen an increase in tick-borne bacterial infections and co-infections in the U.S. and worldwide. These help our customers perform more sensitive detections using molecular means. It’s an important step forward.

We are also launching offerings for atypical pneumonia (not caused by Streptococcus pneumoniae) this year. The new primer pairs are for Chlamydophila pneumoniae and Mycoplasma pneumoniae and Legionella species, all of which will be available before the end of 2019. Those three together provide nice coverage of these other bacteria that are difficult to detect using culture or serology and are more easily detected using molecular means.

What is the one (or two) most important thing readers should know about your system(s)?
Dr. Moore (Roche): The first key point for the Cobas 6800/8800 system is it is self-contained for DNA extraction, PCR setup, and real-time PCR for IVDs and LDTs, yet it is a moderately complex system. When you eliminate human steps and automate with preanalytics and an analyzer, as we have done, you can achieve a moderately complex level of instrumentation, which enables the lab to be more flexible in how it uses its labor to run its systems.

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