Invivoscribe Technologies was founded in 1995.
Our founder, Dr. Jeff Miller, started exploring in vivo cDNA synthesis technologies and developed our first series of commercial reagents working on a single laboratory bench in the laboratories of Drs. Mitchell Kronenberg and Hilde Cheroutre, under a collaboration agreement with the La Jolla Institute for Allergy and Immunology (LIAI), then located on Science Center Drive in La Jolla, California.  Dr. Mitchell Kronenberg, Dr. Howard Grey (then President/Scientific Director), Dr. Stephen Wilson, and Charles A. (Skip) Carpowich, Jr., were the early supporters of our company.  Though we no longer have formal ties to LIAI and Invivoscribe and its subsidiaries have expanded into dedicated facilities in three countries, we continue to support of this excellent world-renowned research institute, and Drs. Mitchell Kronenberg (now President & Chief Scientific Officer) and Stephen Wilson are members of our Scientific Advisory Board and our Board of Directors.

We secured our first revenue stream developing, validating, and commercializing a series of standardized, PCR-based B-cell and T-cell clonality (Ig and TcR gene rearrangement) assays. These assays provided the resources necessary for the early growth of the company. Following release of the first of these gene rearrangment products, Invivoscribe became aware of a series of valid issued patents that were dominant in the area of gene rearrangement testing and the company moved quickly and secured world-wide exclusive rights to these patents. Our line of gene rearrangement and gene translocation assays was further expanded with the introduction of commercial versions of the tests developed by the EuroClonality/ BIOMED-2 Group (see below).

Collaboration with the EuroClonality/ BIOMED-2 Group

Almost a decade ago we formed an alliance with the EuroClonality/ BIOMED-2 Group around their outstanding work towards standardized clonality testing.  Their seminal study: BIOMED-2 Concerted Action BMH4-CT98-3936 as published [Leukemia (2003) 17, 2257-2317] was followed by a second study that built on their previous work [Leukemia (2007) 21, 201-237].  Invivoscribe has exclusive worldwide rights to commercialize clonality products developed by the BIOMED-2/EuroClonality Group. We are proud to be associated with this outstanding group of scientists and clinicians representing 47 institutions in seven European countries.

Founding of our French subsidiary

Invivoscribe Technologies, SARL, was founded in 2005 as a sales and distribution hub for our customers in Europe. Located in the coastal city of La Ciotat just east of Marseille, our office has a dedicated SARL staff that provides comprehensive sales support and limited technical support for our EU customers. The majority of our EU customers purchase CE-marked IVD products.

Licensing FLT3 & NPM1 biomarkers. Founding our Clinical Laboratory, LabPMM

In 2006 we obtained an exclusive world-wide license (ex-Japan) from Takara Biosciences to patents covering FLT3 mutation testing. The Laboratory for Personalized Molecular Medicine (LabPMM) a CLIA- and CAP-accredited international reference laboratory was founded in 2007 to provide access to testing for the FLT3 biomarker as well as other personalized molecular diagnostic tests. In 2009 we followed this strategic investment by obtaining a license to test for the NPM1 biomarker from Xenomics, Inc. (now Trovagene, Inc). LabPMM is the only reference laboratory licensed to perform testing for FLT3 and NPM1 mutations - the two most important prognostic biomarkers for karyotype normal AML. Current WHO guidelines include assessment of FLT3 mutation status as a "standard of care" in treatment of acute myeloid leukemia. LabPMM provides comprehensive FLT3 mutation testing, as well as testing for the NPM1 biomarker, and provides the only access to a standardized, IP-protected test that consistently determines FLT3 mutation status. FDA clearance of the first targeted therapy for AML that requires FLT3 mutation testing is expected as early as 2013, and we are currently working with pharma and the FDA toward regulatory clearance or approval of a FLT3 companion diagnostic.

Move from Partnership to Corporation

In 2008, our company undertook the next phase in our growth cycle: a move from a partnership to a corporation. This transition was made effective in October of 2008 when IVS Technologies, LLC became Invivoscribe Technologies, Inc.

Invivoscribe currently manufactures more than a thousand different products in our GMP facility in San Diego, CA. These products include general purpose reagents (e.g., PurePlus™ enzymes), as well as a comprehensive selection of PCR-based reagents and controls for gene rearrangement, chromosome translocation, and gene mutation testing.

Founding of our software company, LabFlow, LLC

Our subsidiary, LabFlow (labflowsoftware.com) was founded in 2009 to develop a comprehensive ERP software solution required to integrate our multiple inter-dependent but separate businesses. Our first fully integrated business package was launched and Invivoscribe Inc. started using the software for all business processes on February 1st 2010. Invivoscribe SARL started using it exclusively on January 1, 2011.  Both LabPMM LLC and LabPMM GmbH validated and started relying entirely on the software system on January 8, 2012.  LabFlow software was built upon Microsoft Dynamics NAV, but substantively expands its capabilities. Our software requires minimal customization, is scalable with minimal IT support, and is designed to integrate with LIS, LIMS, and business packages. This flexible and scalable software provides consolidated real-time financials and product tracking for our many business units.

Founding of our European clinical reference laboratory, LabPMM GmbH

In order to better serve pharma and the international community we are in the process of setting up a new reference laboratory, LabPMM GmbH, in district Planegg, in Martinsried, Germany. LabPMM GmbH was founded to be a replica of our clinical reference laboratory, LabPMM LLC.  For example, Standard Operating Procedures for all tests and business processes are identical, and employees at both sites will be hired, trained and supervised by the same personnel. Test reagents used in laboratories at both sites will be produced under GMP at our manufacturing facility in San Diego. Instrumentation, firmware and software will be as identical as is possible. Our goal is to set up a 'cloned' regional clinical laboratory for reference and clinical trials testing. LabPMM GmbH will be licensed and accredited to the ISO15189 standard and is expected to start accepting and testing its first clinical samples starting 1Q 2012.

Partnering with Novartis and other pharmaceutical companies to bring new drugs to market

In early 2011 IVS finalized a collaborative agreement with Novartis to develop, obtain regulatory approval, and commercialized a FLT3 companion diagnostic for their development compound, midostaurin, which is in phase III clinical trials.  IVS is currently negotiating a number of collaborations and business opportunities to in-license further IP and initiate development, validation and regulatory approval of companion diagnostics for drugs targeting biomarkers of therapeutic interest.

Extending our relationship with Monoquant Pty Ltd to bring new technologies to market

In late December 2010 Invivoscribe and Monoquant Pty Ltd finalized an exclusive license agreement that extends our decade-long relationship around molecular diagnostic testing and personalized molecular medicine in hematology-oncology.  We are very happy to be working with such a dedicated and accomplished team in Adelaide, Australia.

Invivoscribe and our subsidiaries remain focused on developing and commercializing products for personalized molecular diagnostics™, and personalized molecular medicine™ for use in the fields of hematology-oncology and hematopathology.