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GenoLogics Opens New Office, Increases Headcount to Handle Growing Customer Base

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NEW YORK (GenomeWeb) – GenoLogics is expanding its business in response to the current demand for its flagship product, Clarity LIMS, a laboratory information management system that's designed for use in life science research and clinical environments.

The privately held company recently opened a new office in Redwood City, Calif., and hopes to hire 15 individuals in 2015 to fill multiple positions in software development, support, product management, and operations. The added staff will bring the company's total headcount to 65 employees, up from 50 as of last year, and will enable the company to better support its growing customer base.

According to CEO Michael Ball, GenoLogics doubled its client list in 2014, with record sales coming in from customers in Europe. It claims to have doubled its revenues for the year as well. Its roster of customers includes early-stage molecular diagnostics companies and hospital laboratories that are starting to offer next-generation sequencing-based diagnostic tests and panels as part of their repertoires and are seeking lab infrastructure that enable them to manage and track samples per regulatory requirements and provide accurate results, Ball told GenomeWeb.

He attributes the growth in the company's business to increasing use of next-generation sequencing in clinical applications and the growing recognition of the role of lab infrastructure in enabling diagnostics providers to meet regulatory requirements and produce consistent results. Labs working in research contexts may be able to cobble together workable internal systems or make do with spreadsheets, but those sorts of homegrown solutions aren't sufficient for regulated environments, he noted. "You can't afford to give incorrect results, so you need a good LIMS to make sure that you've tracked everything from patient sample received into the lab right through a physician report at the end."

GenoLogics had those clinical clients in mind when it launched Clarity LIMS in 2012. The company, which historically had developed LIMS for the research market, was hoping to tap into the then nascent market for NGS-based clinical applications and tests. It reworked its research-centric solution to include features that would help labs seeking to meet the more stringent demands of CLIA-regulated environments.

Features in that first iteration of the solution included a newly designed interface, and tools to plan experiments, track and manage samples as they moved through relevant lab workflows, and to automatically transfer data from instruments to analysis pipelines. In tailoring the solution for clinical use, GenoLogics made sure that Clarity could still support research-oriented use cases if need be, Ball noted. Customer labs typically run research projects alongside clinical ones "and so having a software platform that can work both on the research side and ... be reconfigure[d] for new tests [on] the clinical side where it's completely locked in and never changes ... is actually one of the key requirements of this market," and one that many existing solutions do not address, he said.

At the time of the first Clarity release, Ball said, most labs developing clinical next-generation sequencing applications were focused on ensuring that their test procedures and workflows primarily met CLIA regulations. But in the intervening years, the company has seen labs increasingly move into other highly regulated environments where they are required to meet more stringent requirements, such as the US Food and Drug Administration's 21 CFR regulations or regulations set by the International Organization for Standardization, according to Ball. 

Clarity has evolved to meet those needs as well as now including features such as electronic signatures and formal audit trail reporting. GenoLogics has established a straightforward procedure for validating software in clinical labs and it offers to help labs navigate the validation process, Ball said.

GenoLogics has begun offering Clarity on the cloud, in addition to providing an on-premise option that has proved quite popular even among customers in the clinical arena, who make up about half of the company's cloud-based clientele. "We certainly see our share of groups that are not ready to go to the cloud as it relates to clinical customers, but we are also seeing a large cohort of customers who understand [that the] level of security and compliance that can be achieved in the cloud, [can be the same] as they could achieve on site and sometimes even higher," he said.

Given its popularity and the benefits to customers of running the solution remotely, enhancing the cloud-based version of Clarity will be a major focus for GenoLogics this year, according to Ball.

"We think it's an easier implementation for customers. It eliminates requirements for IT resources ... and it takes a lot of the day-to-day management off the plate of the labs who just want to focus on running tasks and not on computer software," he said.

The company will also work on improving its reporting capabilities to better address the different reporting requirements that labs have, he said.  Furthermore, it will look to establish additional partnerships with software and hardware vendors, similar to the one it has with Illumina, to ensure that its LIMS integrates easily with their infrastructure as well. It hopes to announce some of these newer arrangements later this year, Ball said.

Since it launched the software, GenoLogics has sold its LIMS to clients such as Genomic Health, the Peter MacCallum Cancer Center, Personalis, the Science for Life Laboratory, GenomeDx, and Illumina's CLIA lab. GenoLogics also has on ongoing arrangement with Illumina to support workflows and integrations for multiple sequencing instruments including the HiSeqX Ten

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