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Lab21, Decode Genetics, Scienta Health, GeneNews, Gene Express, NeoGenomics, US Food and Drug Administration, Simulations Plus, Transgenomic, Rosetta Genomics, MD Anderson Cancer Center

Lab21 to Distribute DeCode Tests in UK, Ireland
Lab21 said this week that it will offer five of Decode Genetics’ tests in the UK and in Ireland, and it will have the rights to offer new tests that are not yet on the market.
The agreement allows the Cambridge, UK-based Lab21 to offer Decode’s tests for type 2 diabetes, myocardial infarction, atrial fibrillation, prostate cancer, and glaucoma, as well as an upcoming test for the risk of estrogen-positive breast cancer and “a pipeline” of other tests Decode has in development.
Lab21 also offers tests from Myriad Genetics and PGxHealth, including tests for various cancers and for cardiovascular disease. The company said that all the Decode tests it has agreed to market have “full regulatory approval.”
Financial terms of the agreement were not released.

Toronto Health Clinic to Offer GeneNews' Colorectal Cancer Test
Scienta Health, a Toronto-based health clinic, will offer GeneNews’ colorectal cancer risk-assessment test to its patients, GeneNews said this week.
Scienta will offer ColonSentry to its clients as an “optional component” in their annual health assessments, Toronto-based GeneNews said.
Elaine Chin, chief medical officer and co-founder of Scienta Health, said in a statement that ColonSentry “provides a more accurate and reliable basis for recommending colonoscopies than demographic benchmarks or the less sophisticated occult blood stool test.”
Heiner Dreismann, interim CEO and lead director of GeneNews, said that the partnership with Scienta is an example of “one component” of the company’s commercialization strategy for ColonSentry. “In the coming months, we expect to roll out our test in additional regions in Canada and target private health insurers to include our test under their healthcare offerings,” he said.

Gene Express, NeoGenomics Ink Licensing, Validation Agreements
Gene Express said this week that it has signed three agreements with NeoGenomics Laboratories covering licensing, commercialization, and FDA validation of its gene expression and reverse transcription PCR technologies.
Under the terms of the agreements, NeoGenomics will license Gene Express’s Standardized Expression Measurement Center, or SEM Center, and Standardized Reverse Transcription Polymerase Chain Reaction, or StarRT-PCR, technology.
NeoGenomics also gains the rights to commercialize Gene Express’s diagnostic tests, to validate future Gene Express technology to fulfill FDA requirements, and to use the company’s StaRT-PCR technology for its own commercial activities.
NeoGenomics will also help Gene Express validate its own tests for lung cancer risk and BCR/ABL gene expression.
Gene Express said it plans to complete the clinical validation and submission for FDA approval for the lung cancer test in the fourth quarter of 2008, and it plans to start clinical trials for the BCR/ABL test in the first quarter of 2009.
NeoGenomics is a clinical reference lab focused on cancer genetics diagnostic testing, and it has operations in Fort Myers, Fla., and in Irvine, Calif.
Financial terms of the agreements were not released.

FDA Licenses ADMET Predictor from Simulations Plus
Simulations Plus said last week that the US Food and Drug Administration has licensed its ADMET Predictor software for use in its Cardiovascular and Renal Products division.
ADMET Predictor predicts approximately 80 properties of molecules, including physicochemical, biopharmaceutical, metabolism, toxicity, and some activity properties, based on their molecular structure.
Financial terms of the agreement were not disclosed.

Transgenomic Posts Flat Sales in Q2
Transgenomic last week reported nearly flat revenues in the second quarter of 2008, and its profit dropped 55 percent in the quarter compared with the year-ago period.
The Omaha, Neb.-based genetic test provider said that it brought in revenues of $6.2 million for the three-month period ended June 30, roughly the same number it recorded in the second quarter of 2007.
The company said its third consecutive quarter of profitability came from stable instrument and consumables sales and growth in its Molecular Clinical Reference Library and from its Pharmacogenomics Services Laboratory business.
Specifically, Transgenomic said it saw a 52 percent increase in net sales from its lab services business, and a decrease of 7 percent in its instrument-related sales.
Transgenomic President and CEO Craig Tuttle said the company continues to build customer validation of its discovery and detection services, and it is working to increase sales from its reference lab and its pharmacogenomics business with drug makers. Tuttle also said that the company is seeking new collaborations in Phase III clinical trials that could bring in more revenue.
Transgenomic posted a profit of $101,000, compared to a net profit of $226,000 million in the second quarter of 2007. Last year’s second quarter included a $937,500 gain on the sale of an investment in equity securities, which was partially offset by restructuring charges of $624,000 related to the closing of a production facility in England and an administrative office in France, the firm said
The firm’s R&D spending rose to $560,000 from $492,000, while its SG&A costs were flat at $3.1 million.
Transgenomic finished the quarter with $5.7 million in cash and cash equivalents.

Decode Nearly Doubles Revenues in Q2
Decode Genetics reported last week that its second-quarter revenues nearly doubled to $15 million from $7.6 million year over year.
The Reykjavik, Iceland-based biopharmaceutical and molecular diagnostics firm noted in a statement that it also has $15.1 million in deferred revenue that will be recognized over future reporting periods.
Decode’s net loss increased 13.6 percent to $18.4 million from $16.2 million. The quarter includes $1.2 million in non-operating expense tied to a revaluation of the firm’s non-current auction rate security investments. Decode also had taken charges in each of the previous two quarters related to the auction-rate securities.
The company’s R&D spending was cut 44.8 percent to $8 million from $14.5 million year over year, while its SG&A expenses edged up 4.4 percent to $7.1 million from $6.8 million.
Decode finished the quarter with $23.7 million in cash, cash equivalents, and current investments.
“As we ramp up our sales efforts in diagnostics and decodeMe, our discovery engine is providing us with a steady stream of intellectual property and content for new tests that leverage the same product development infrastructure,” Kari Stefansson, CEO of Decode, said in a statement.

MD Anderson to Perform Clinical Validation Study for Rosetta Genomics' CUP Test
Rosetta Genomics said this week that the University of Texas MD Anderson Cancer Center will perform a clinical validation study for its microRNA-based test designed to locate the primary site of cancers of unknown primary origin.
The study will include 100 patients who are diagnosed with CUP and who meet other eligibility criteria. The company said it plans to submit its test for regulatory approval sometime before the end of this year.
Amir Avniel, president and CEO of Rosetta Genomics, said in a statement that validation studies such as this are “an integral part of the commercialization roadmap for our diagnostic tests, as we advance them towards use in a clinical setting.”
CUP cancers account for between three and five percent of all cancers, and they have a median survival of between six and ten months.
Around 70,000 patients in the US each year receive a CUP diagnosis, usually after undergoing “a wide range of tests … which often fail to identify the origin of the cancer,” the company said.
Gauri Varadhachary, an MD Anderson oncologist, said that a microRNA-based CUP assay “may present an alternative to current diagnostic practices.”
Varadhachary said that the study will attempt to validate the assay and compare its performance to other currently available CUP tests.

Filed under

The Scan

Germline-Targeting HIV Vaccine Shows Promise in Phase I Trial

A National Institutes of Health-led team reports in Science that a broadly neutralizing antibody HIV vaccine induced bnAb precursors in 97 percent of those given the vaccine.

Study Uncovers Genetic Mutation in Childhood Glaucoma

A study in the Journal of Clinical Investigation ties a heterozygous missense variant in thrombospondin 1 to childhood glaucoma.

Gene Co-Expression Database for Humans, Model Organisms Gets Update

GeneFriends has been updated to include gene and transcript co-expression networks based on RNA-seq data from 46,475 human and 34,322 mouse samples, a new paper in Nucleic Acids Research says.

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.