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Sapio Sciences Announces Exemplar Dx LIMS for Laboratories in the burgeoning MDx Market

Posted: January 31, 2012

Sapio Sciences is pleased to announce the immediate availability of Exemplar Dx LIMS. This release is the result of Sapio's extensive experience in implementing LIMS at leading MDx companies. Exemplar Dx LIMS addresses MDx company's operational needs in a single, integrated solution.

The MDx Market

The molecular diagnostics market is experiencing rapid growth largely due to advances in genetics/ genomics/proteomics technologies over the last decade that have enabled significant discoveries to be made in predictive biology. Many commercial companies are emerging with new tests in combination with proprietary algorithms to make useful predictions for patients, such as which drug to take for a particular cancer. In order to commercialize these tests, a Molecular Dx company will typically establish a lab for sample processing and assessment. For US based labs to conform to regulations, the entire process from sample receipt to sample processing needs to be compliant with CLIA regulations.

MDx Company Requirements

Molecular Dx labs have a diverse set of information technology needs that span well beyond what is traditionally thought of as "Lab Information Management". All or some of the following are often needed:

  • An ordering system for physicians to enter test requests
  • Collection Kit Management
  • Pathology Lab Interfaces
  • Sample Management/Lab Workflow Tracking - Electronic Lab Notebook
  • Instrument Integrations for Lab Automation
  • Assay Data Management
  • Custom Algorithm Implementation
  • Automated Diagnostic Report Creation with E-signature
  • Medical Billing
  • HL7 Support, CLIA compliance, validated

Exemplar Dx LIMS addresses each of these needs while allowing for configuration\customization to meet each companies specific requirements.

MDx Test Reimbursement

MDx companies need to handle the collection and processing of payment information for their tests. The payment processing is typically done with a third party provider who specializes in billing for these new tests. As insurance companies and Medicare are still becoming familiar with molecular tests, having a billing provider who is experienced in working with these agencies is critically important to getting proper reimbursement.

Sapio is pleased to announce that as part of the Exemplar Dx LIMS offering that we have selected GGB Medical Management as our preferred billing provider. Exemplar Dx LIMS has a pre-built, automated integration between Exemplar and GGB's information systems that ensures proper and timely data transfer. "GGB has extensive experience handling the billing needs of the MDx market, which requires a deep understanding of the evolving regulations to ensure proper processing and reimbursement in a timely fashion.", says Rob Gerstien, president GGB, "We have already worked with Sapio and their Exemplar product for MDx products at a leading MDx company and found their team and technology to be top tier.  We are enthused to be partnering with them and to be providing a comprehensive solution for the growing molecular diagnostics market."

"The Exemplar Dx LIMS product release is the culmination of years of experience working with leading MDx companies who are bringing their new tests to market. Now, for the first time, MDx companies can get a single solution that addresses everything from the original test request through its processing and results delivery to the test requestor in a fully electronic, automated pipeline." says Kevin Cramer, VP of Sales and Marketing at Sapio.

Kevin continues, "We are also excited to be formalizing our relationship with GGB who we have worked with previously and found their technology platform straightforward to integrate with Exemplar for automated information transfer. Just as important is that GGB has demonstrated expertise in getting reimbursement for their clients, which can be challenging with these new molecular based tests."

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