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A new connection with Genection
SAN DIEGO—In a move meant to provide better access to genetic testing for the market as a whole, privately held Invivoscribe Technologies Inc. has launched Genection Inc., a personalized molecular medicine company. Genection will offer physicians a dedicated online platform for global access to the clinically actionable genetic test menu, including routine and esoteric genetic tests, pharmacogenomics, cancer somatic mutation testing and exome and whole-genome sequencing.
Genection is intended to ease and improve both access to genetic tests and communication about the process among all involved parties. The company's web application offers HIPAA- compliant patient data management for physicians and health organizations, providing a secure method for clinicians to share test results and genetic information with other healthcare providers.
"In order to make personalized molecular medicine a clinical reality, new platforms need to be developed for the delivery of healthcare. Genection's mission seeks to accelerate this adoption process," Dr. Bradley Patay, chief medical officer at Genection, said in a press release. "The combination of CLIA-validated genetic testing, whole-exome or whole-genome sequencing and broad targeted assays, along with critical bioinformatics, analytic tools and interpretative guidelines will contribute to timely definitive diagnoses for patients with rare, unexplained diseases or complex diseases; in essence, this integration will speed delivery of genomic test results and improve patient care."
The new company's model is not payor driven, which will allow physicians access to genetic tests that may be unavailable or inaccessible through their patients' care plans and healthcare institutions. In addition to the genetic test offering, Genection will also provide online ordering, advanced bioinformatics and linking of multiple CLIA- and CAP-accredited laboratories for reporting, interpretation and integrated services offerings.
Suzanne Graham, senior manager of business development for Genection, noted in a press release that the company's initial CLIA- and CAP-accredited laboratory partners include "ARUP Laboratories, Foundation Medicine, Cypher Genomics, the Laboratory for Personalized Molecular Medicine (LabPMM) in the U.S., as well as its ISO15189-compliant laboratory (LabPMM GmbH) in Martinsried, Germany." The company also has relationships with sequencing providers such as Illumina and Ambry Genetics and a consortium of genetic counselors.
"Genection is a valuable tool in the personalized molecular medicine landscape. Clinicians spend too much of their time identifying and ordering clinically relevant genetic tests, while struggling to keep abreast of the flood of clinical information around new biomarkers," said Patay in a statement. "In addition to the broad selection of genetic tests available to order through their service, Genection offers one of the most relevant new genomic testing services next-generation sequencing used to detect driver mutations in cancer."
Genome sequencing costs have been dropping steadily in recent years, Genection notes on its website, and highlights three primary areas in which personalized molecular testing is particularly advantageous: carrier testing for individuals looking to become pregnant, cancer treatments and drug treatments. Genection provides carrier testing for conditions such as cystic fibrosis, sickle cell anemia and Tay-Sachs disease, all of which can be tested for before pregnancy. Cancer testing can identify patients' specific cancer types to enable more effective treatment, and pharmacogenomics—genetic testing to determine the efficacy of a drug and predict potentially fatal reactions—can save lives, as Genection notes that "adverse drug response is the sixth most common cause of death in the United States."
In addition to its genetic test offering, Genection is also a gateway for the Together We Cure initiative, a global program that allows patients with acute myeloid leukemia and their physicians to share clinical information. As Genection explains on its website, "Together We Cure is the first initiative that provides a global portal promoting and providing access to comprehensive molecular testing of each patient's cancer in order to accelerate our knowledge and progress towards finding a cure." The information is shared in a HIPAA-compliant, anonymous manner.
Genection is a privately held company owned by Invivoscribe Technologies. 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 in December 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 to facilitate and conduct patent covered tests for the presence of internal tandem duplication (ITD) mutations in the FLT3 gene.
FLT3-ITD mutations constitute an important known marker for refractory acute myeloid leukemia (AML). These mutations are detected in approximately one third of AML patients and correlate with poor prognoses.
Clinical development of drugs effective for patients having the FLT3-ITD mutation are in clinical trials worldwide. By testing for the presence of FLT3-ITD mutations, patients who are qualified for administration of FLT3-targeted drugs can be identified, resulting in more accurate and clinically effective treatment.
In 2006, Takara Bio granted Invivoscribe an exclusive worldwide license (excluding Japan) to use the patent covering detection method of FLT3-ITD mutations. Under the new agreement, Invivoscribe obtains several licenses, 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 detection in Japan (now with Takara); and a license to directly provide testing services for FLT3-ITD detection.