Dienstag, 5. Mai 2015

The automation gap. A guide to smooth and suistanable automation in the nucleic acid testing market.

From small Laboratories running nucleic acid extraction protocols to the cutting edge Next Generation Sequencing assays; enzymes, primers, modified nucleotides and secret buffers represent a high percentage of the total cost per sample. This article will not discuss about the high margins companies apply to those products or the profits they earn (specially in the IVD regulated market), but focus on how these companies and specially they users can benefit from open platform automation to reduce costs in the long term.

Big diagnostic companies such as Roche, Beckman Coulter, Siemens, Becton Dickinson or Illumina are now presenting their own automation platforms to fulfill de demands of the high throughput clinical users in the nucleic acid testing market. These vast systems are not cheap and only works with their own kits and reagents. Reagents forced to have increased prices because they have to pay the development, manufacturing and maintenance of both the kit and the huge system that performs the assay.

On the other hand, small companies do not have the resources to develop that can’t develop their own closed system but are more versatile to develop and improve new assays to fulfill specific needs faster. Brands like Biomerieux, GenDX, Kapa Biosystems, Seegene or New England Biolabs represents some of the players in this side of the market.

So how the gap is closed between these close systems that bring ease of use but at high costs, and their alternatives kits that are available on the market but with no automation?

The answer is to set some standards to smooth Open Platform Lab Automation (OPLA)

Companies like Hamilton Robotics, Tecan or again Beckman Coulter offer these OPLA systems that virtually can fit any protocol you might think about (if you have the money and the know-how). The difference is that these platforms do not become obsolete once the kit or the technology become old. These robots automated the 1st DNA extraction kits, and can still automate the latest version of the library prep for NGS and no doubt will automate whatever the future brings to the lab, so OPLA systems reduce the hardware cost and the amount of waste produced in the long term.

So… why we are not doing it?… here are some reasons and some thoughts….

One main handicap when it comes to automate kits in open platforms is that usually they’re not mend to be automated and lack some basic features or even the know-how.

The points discussed below might seem simple but all of them are essential to achieve a a proper automation with less efort, and at this point size does not matter, all small and big companies can easily adapt their kits to work with an OPLA systems and benefit for them.

1-Labware uniformity:

There are literally dozens of tubes formats ranging from 0,2 to 2ml working volume. Labware definition is usually a problem when writing the scripts to automate a protocol, so try to package the different reagents in the fewer amount of tube types. For example, try to package all controls, enzymes and high-valuable reagents of all your kits in the same tube format. And make sure this labware is common enough to fit any liquid handler without major problems. Also consider that both description and barcode labeling are desired to fit in the tube side.

2-Reduce human intervention

This is one of the driving arguments why people want to automate their highly expensive assays. Humans may fail or simply they are not reproducible enough while robots perform the same task always the same way (might be slower, might be even less efficient, but robustness comes built-in). Reducing human intervention is easy to achieve by barcoding every labware so the robot can check itself that the reagent has been placed properly and even trace the lot number for future audit trails.

Most robots achieve the greatest efficiency when working with 8 channels, so try to present the reagents in SBS reservoirs where all channels can work simultaneously, this avoids the user to pour the reagent in the reservoir manually and limits reduces errors.

These SBS reservoirs can be efficiently cooled on deck, and sealed afterwards to ensure proper performance across different assays and reducing death volumes on the long term.

3-Increase volumes.

Robots lack eyes, and they can face some struggle when trying to aspirate 100ul from a tube that contains exactly 105ul and needs to multidispense 10ul on each well). Of course companies will be reluctant to increase the amount of precious reagent they put to their vials, but on the long term perspective an automated solution will decrease the amount of replacement kits given away because “mysterious reasons” when something goes wrong on the manual way and the there is no proper proof of what may gone wrong. Robots write down everything they do and it’s easy to track down and solve problems.

Also ease of use and automation will surely open the doors to mid and high throughput users, meaning more sells with less troubles.

4-Ensure a proper support.

None of the above points is useful without this one. Supporting the costumers have to be always a main focus on these companies, as mentioned above there are only few companies able to provide worldwide open automation platforms and its support. The know-how to support these platforms can come from many sites.

In a market worth billions of dollars, the benefits of hiring and proper training of own employees in the “dark arts” of liquid handling programming will soon overcome the initial investment.

Another option are that the users themselves grow the network to support each other, in a world where Linux has been developed only with the effort of none-profitable contributors, the potential of a well-organized OPLA users able to share their know-how, methods and experiences for no money it is plausible.

Probably the best way to go will be a common organization such as SILA consortium, where kit providers, robot manufacturers AND USERS can discuss the pros and cons of the idea behind this article. Meanwhile, if you are a kit or reagent manufacturer, try to follow the points mentioned above to offer an easy way to liquid handling automation.

The automation gap. A guide to smooth and suistanable automation in the nucleic acid testing market.

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