Invitrogen Gains FDA Premarket Approval for HER2 Test
Invitrogen said this week that it has received US Food and Drug Administration premarket approval for its SPOT-Light HER2 CISH kit, which can be used to assess whether breast cancer patients should be treated with Genentech’s Herceptin (trastuzumab).
Invitrogen said that this is the first premarket approval that it has received from the FDA.
The SPOT-Light kit is based on chromogenic in situ hybridization, or CISH, which the company said offers a number of advantages over currently available HER2 tests based on immunohistochemistry or fluorescent in situ hybridization.
CISH test results are obtained using a standard bright-field microscope, while FISH tests use a fluorescent microscope, which “frequently requires that the analysis is done at a reference lab,” the company said. Invitrogen added that HER2 CISH test results are “quantifiable,” as opposed to IHC interpretation, which is subjective.
Because the HER2 CISH kit does not require specialized equipment, “any histology lab can now assess amplification of the HER2 gene while simultaneously examining tissue morphology," said August Sick, vice president and general manager of Invitrogen's Cellular Analysis Business, in a statement.
Jeffrey Ross, chair of the department of pathology and laboratory medicine at Albany Medical College, said in a statement that the CISH method has shown a “high concordance” with FISH-based assays for the identification of HER2 gene amplification.
“When used with other clinical information and laboratory tests, this test can provide healthcare professionals with additional insight on treatment decisions for patients with breast cancer,” said Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, in a statement.
The FDA said that it based its approval of the test on a study using tumor samples from patients with breast cancer in the US and Finland. "These studies confirmed that the test was effective in determining how many HER2 genes were in these patients," the agency said.
Invitrogen said it will begin offering the HER2 CISH kit in the US in mid-August.
Solvay Raises Bid for Innogenetics; Gen-Probe Folds
Solvay Pharmaceuticals this week increased its bid to acquire Belgian molecular diagnostics firm Innogenetics to €6.50 per share from an initial offer that it made in April of €5.75 per share.
Gen-Probe, which made a counteroffer of €6.10 per share in early June, said this week that it does not intend to increase its offer.
Solvay said that the transaction value of its offer is €200.7 million ($316 million) for 100 percent of Innogenetics’ outstanding shares. This represents a 74 percent premium to Innogenetics’ closing price on April 24, the day before Solvay made its initial offer.
Innogenetics trades on the Euronext Brussels exchange.
Solvay said it expects the acquisition to close in the second half of 2008, pending approval by Belgium's regulatory authorities and Innogenetics’ board.
In a statement, Hank Nordhoff, Gen-Probe's chairman and CEO, said that the company believes “the disciplined analytical process we used to value Innogenetics resulted in a full and fair offer, and a higher bid therefore does not make financial sense for us."
Affy to Distribute Asuragen's IVT Reagent Kits for Molecular Diagnostics
Affymetrix will market Asuragen’s in vitro transcription reagent kits for use with its diagnostic microarray platform, the companies said this week.
Under the terms of the agreement, Asuragen will develop and manufacture IVT reagent kits configured for use with Affy’s GeneChip System 3000Dx, a diagnostic microarray platform that has gained 510(k) clearance from the US Food and Drug Administration and the CE mark from the European Union.
Kevin King, president of Affymetrix, said in a statement that the kit will “strengthen our growing diagnostic product portfolio."
NIH Tweaks Collaboration, Education, and Genetic Test Translation Program
The National Institutes of Health is making some funding and other adjustments to a pilot program focused on helping researchers translate genetic tests from the lab to the clinic by promoting collaborations between scientists, clinicians, laboratories, and disease-specific advocacy groups.
Among the changes, the NIH has added funding to compensate researchers for the time investment needed to apply.
Run by the NIH’s Office of Rare Diseases, the Collaboration, Education, and Genetic Test Translation, or CETT, Program is aimed at supporting researchers who are developing a new gene or assay technology into a clinical diagnostic test that can be used to diagnose and even manage a disease.
The CETT Program also hopes to give researchers focused on rare diseases help in forming a relationship with a lab and patient advocate groups.
NIH said in a program announcement last week that it expects the program to help these scientists focus on research, and not on clinical care or service, and to enhance the knowledge base that is obtained from the collection and storage of clinical data. The program also should help scientists identify new subjects from expanded access to clinical testing and documented findings, and help them provide results to research participants and their families.
Because NIH has realized that building the collaborations needed to apply involves work that previously was uncompensated, all applications for CETT funding received after June 1 qualify for $3,000 in funding to support collaboration development.
NIH also has doubled the funding it gives to applicants for the CETT program from $1,000 to $2,000 for all who have applied after June 1, and it now only requires two versions of educational materials instead of three. Each application received after June 1 also qualifies for $5,000 to support the translation and clinical consultation activities spent by the research member of each CETT Program application.
More information about the changes in the CETT program can be found here.