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

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Second, our system is designed to allow laboratories to consolidate their highest volume of FDA-approved and -cleared tests, as well as all their LDTs, on a single moderately complex instrument. Customers tell us this is of great value to them.

Stevenson (BioFire): Our standard line is fast, easy, comprehensive, and allows labs quickly and easily to test for a comprehensive set of pathogens.

Dr. Tabb (DiaSorin Molecular): First, we are committed to growing our menu. We have a system that has a small footprint, and we are committed to bringing up more assays that can be run on it. Second, we have unique flexibility. By changing a disk within the same system and the same software, our system can run the full gamut from the most highly complex LDT (that the user has to validate) or the most easy-to-use CLIA moderate-complexity IVD that is FDA cleared.

What molecular testing market changes does your company foresee, if any?
Dr. Moore (Roche): Two things driving market dynamics are consolidation and decentralization, going on in parallel. This means if there is a patient intervention that can achieve good outcomes by quick action, testing necessarily gravitates closer to the patient and out of the lab. That is the decentralization pull.

At the same time outpatient-based screening and monitoring tests are being consolidated to improve efficiencies. Certainly within laboratories, there are efforts to choose a single platform to accomplish much of the core molecular testing, whether FDA approved or LDT. There are now options to consolidate that testing.

Stevenson (BioFire): The continued adoption of syndromic testing is a trend. Now about 1,500 hospitals in the U.S. are doing syndromic testing; that number has grown 20 to 30 percent every year. Our compound annual growth rate over the past five years has been about 98 percent a year. We anticipate growth will continue. Hospitals and health systems increasingly understand the value of rapid syndromic testing.

Dr. Tabb (DiaSorin Molecular): We have noticed that despite lingering questions about whether the FDA will eventually regulate LDTs, concern seems to have stabilized for now. Labs still want to develop their own LDTs and need components, like primer pairs, to support that. Especially in lower-volume esoteric testing, as in infectious diseases, companies will not bring that type of testing all the way through the FDA process. It is much too burdensome and expensive.

What is your company hearing from its customers, in terms of laboratory needs and wants?
Dr. Moore (Roche): We see that labs, microbiology labs in particular, are going through significant transformation and incorporation of innovation. But how can those molecular micro labs get true sensitivity results back to the health care providers so they know a patient is not just infected with this bacterium that is resistant to XYZ drug but also exactly what they can treat with? Labs tell us that’s what doctors want to know.

So far, this is a need that is not quite being met. It is an area we are pursuing heavily with a technology called Smarticles, which will provide molecular phenotyping. Smarticles will be able to identify a bacterium and determine what it is most sensitive to from an antibiotic standpoint. It is an automated technology we are maturing and will bring out on an instrument called VivoDx, a new benchtop analyzer to be used within the microbiology lab. (Smarticles is in development and not yet available.)

Additionally, we continue to bring out a healthy pipeline of IVD tests to expand the menu on existing platforms so labs can continue to consolidate testing. However, there seems to be additional appetite from our customers to do LDT applications, and customers’ interest drives our investments in our products.

Stevenson (BioFire): We hear from labs that they are continually challenged to do more with reduced resources. Budgets and lab workforces are shrinking, but oddly enough health care institutions are still asking for faster turnaround times, more accurate tests, and better services. Technology is helping by making it possible to provide faster, more comprehensive testing services. Our customers want cutting-edge molecular technology to offer improvements over culture in terms of sensitivity and specificity.

Dr. Tabb (DiaSorin Molecular): In general we’ve seen a continual drive for molecular diagnostics. People want those specialized targets, and they keep increasing their molecular menu offering. The switch from culture-based methods to molecular is still happening. We hear, “Give me more molecular.”

We are listening to our customers about problems they have in the lab, such as pathogens that are difficult to culture, and trying to bring products to the market that will help them accordingly. We plan to continue to offer more primer pairs to support our customers’ LDT efforts, and keep our IVD pipeline as hot as possible.

Finally, the big thing customers continue to ask for is more automation, often with onboard extraction. Labs are cognizant of technician injury, risk points, and efficiencies in the lab, and automation delivers on all counts. We are exploring how to offer more automated solutions in the various situations where they are needed. If customers need it, we will find a way to provide it.