SAN DIEGO—In a move meant to provide better access togenetic testing for the market as a whole, privately held InvivoscribeTechnologies Inc. has launched Genection Inc., a personalized molecularmedicine company. Genection will offer physicians a dedicated online platformfor global access to the clinically actionable genetic test menu, includingroutine and esoteric genetic tests, pharmacogenomics, cancer somatic mutationtesting and exome and whole-genome sequencing.
Genection is intended to ease and improve both access togenetic tests and communication about the process among all involved parties.The company's web application offers HIPAA-compliant patient data managementfor physicians and health organizations, providing a secure method forclinicians to share test results and genetic information with other healthcareproviders.
"In order to make personalized molecular medicine a clinicalreality, new platforms need to be developed for the delivery of healthcare.Genection's mission seeks to accelerate this adoption process," Dr. BradleyPatay, chief medical officer at Genection, said in a press release. "Thecombination of CLIA-validated genetic testing, whole-exome or whole-genomesequencing and broad targeted assays, along with critical bioinformatics,analytic tools and interpretative guidelines will contribute to timelydefinitive diagnoses for patients with rare, unexplained diseases or complexdiseases; in essence, this integration will speed delivery of genomic testresults and improve patient care."
The new company's model is not payor driven, which willallow physicians access to genetic tests that may be unavailable orinaccessible through their patients' care plans and healthcare institutions. Inaddition to the genetic test offering, Genection will also provide onlineordering, advanced bioinformatics and linking of multiple CLIA- andCAP-accredited laboratories for reporting, interpretation and integratedservices offerings.
Suzanne Graham, senior manager of business development forGenection, noted in a press release that the company's initial CLIA- and CAP-accreditedlaboratory partners include "ARUP Laboratories, Foundation Medicine, CypherGenomics, the Laboratory for Personalized Molecular Medicine (LabPMM) in theU.S., as well as its ISO15189-compliant laboratory (LabPMM GmbH) inMartinsried, Germany." The company also has relationships with sequencingproviders such as Illumina and Ambry Genetics and a consortium of geneticcounselors.
"Genection is a valuable tool in the personalized molecularmedicine landscape. Clinicians spend too much of their time identifying andordering clinically relevant genetic tests, while struggling to keep abreast ofthe flood of clinical information around new biomarkers," said Patay in astatement. "In addition to the broad selection of genetic tests available toorder through their service, Genection offers one of the most relevant newgenomic testing services next-generation sequencing used to detect drivermutations in cancer."
Genome sequencing costs have been dropping steadily inrecent years, Genection notes on its website, and highlights three primaryareas in which personalized molecular testing is particularly advantageous:carrier testing for individuals looking to become pregnant, cancer treatmentsand drug treatments. Genection provides carrier testing for conditions such ascystic fibrosis, sickle cell anemia and Tay-Sachs disease, all of which can betested for before pregnancy. Cancer testing can identify patients' specificcancer types to enable more effective treatment, and pharmacogenomics—genetictesting to determine the efficacy of a drug and predict potentially fatalreactions—can save lives, as Genection notes that "adverse drug response is thesixth most common cause of death in the United States."
In addition to its genetic test offering, Genection is alsoa gateway for the Together We Cure initiative, a global program that allowspatients with acute myeloid leukemia and their physicians to share clinicalinformation. As Genection explains on its website, "Together We Cure is thefirst initiative that provides a global portal promoting and providing accessto comprehensive molecular testing of each patient's cancer in order toaccelerate our knowledge and progress towards finding a cure." The informationis shared in a HIPAA-compliant, anonymous manner.
Genection is a privately held company owned by InvivoscribeTechnologies. Invivoscribe's founder, chairman and CEO, Dr. Jeffrey E. Miller,will serve as Genection's president.
Invivoscribe licenses AML test from Takara Bio
SAN DIEGO—Invivoscribe Technologies Inc. also announced inDecember that it has entered into an agreement with Takara Bio Inc. of Otsu,Shiga, Japan, under which it has been granted a series of licenses tofacilitate and conduct patent covered tests for the presence of internal tandemduplication (ITD) mutations in the FLT3 gene.
FLT3-ITD mutations constitute an important known marker forrefractory acute myeloid leukemia (AML). These mutations are detected inapproximately one third of AML patients and correlate with poor prognoses.
Clinical development of drugs effective for patients havingthe FLT3-ITD mutation are in clinical trials worldwide. By testing for thepresence of FLT3-ITD mutations, patients who are qualified for administrationof FLT3-targeted drugs can be identified, resulting in more accurate andclinically effective treatment.
In 2006, Takara Bio granted Invivoscribe an exclusiveworldwide license (excluding Japan) to use the patent covering detection methodof FLT3-ITD mutations. Under the new agreement, Invivoscribe obtains severallicenses, including an exclusive license to produce and sell in-vitro diagnostic products for FLT3-ITD detection in Japan;a sole license to produce and sell research reagent products for FLT3-ITD detectionin Japan (now with Takara); and a license to directly provide testing servicesfor FLT3-ITD detection.