Qiagen Gets FDA Warning Letter for Molecular Dx Products
The US Food and Drug Administration has sent a letter to Qiagen warning it that certain of its molecular diagnostics currently manufactured in Hamburg, Germany, do not have regulatory approval for sale in the US.
In an Oct. 2 letter to Qiagen CEO Peer Schatz that was posted on the agency’s website this week, the FDA said six diagnostic products manufactured at the Hamburg site are improperly marketed and require regulatory review by the agency. On its web site, Qiagen stresses that the products — tests for herpes virus, lime disease, parvovirus, Chlamydia, and malaria — are designed for use in CLIA labs and therefore do not require FDA oversight.
The FDA, on the other hand, claims that because the tests are packaged with instructions they are subject to agency review.
The products cited by the FDA letter include the artus CMV PCR, C. Trachomatis PCR, C. Trachomatis Plus PCR, Parvo B19 PCR, Borrelia PCR, and Malaria PCR analyte specific reagents.
According to a Qiagen spokesman, only two of the assays have been sold in the US, and their sales are “very immaterial” to the firm. He said the assays are based on older designs from artus, a molecular diagnostics manufacturer that Qiagen acquired last year for around $40 million (see BioCommerce Week 6/2/2005).
The spokesman said that as part of the integration of artus, Qiagen “has already completed or initiated ensuring compliance” of the ASRs.
In its letter, the FDA said it “has concluded that you market these products as ASRs for sale directly to clinical laboratories and not as components intended to be included as part of a finished, packaged, and labeled device as defined in 21 CFR 820.3(c).
“Our review has determined that these reagents are medical devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body,” the agency concluded.
The FDA goes on to say that the products “are not ASRs under 21 C.F.R. 864.4020 and require FDA premarket review prior to being marketed.”
The agency also noted that the tests “are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce these devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
“You should take prompt action to correct the violation(s) addressed in this letter,” the FDA concluded in the letter. “Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed.
The Qiagen spokesman also stressed that the FDA’s letter implied “no issue with product quality,” and the ASRs manufactured at the Hamburg facility were produced using a complaint quality system.
FTC Approves Thermo-Fisher Merger; Fisher to Divest Genevac Business
Thermo Electron said this week that the US Federal Trade Commission has approved its $10.6 billion merger with Fisher Scientific International.
Thermo said the FTC has approved a consent order requiring the divestiture of Fisher's $17-million Genevac business and that it has granted the companies "early termination" of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
Fisher announced its plan to divest a product line in August, but did not disclose which of its subsidiaries would be affected.
Thermo said that no further regulatory review is required in the US to close the merger.
In Europe, the deadline for the European Commission to rule on the merger has been extended to Nov. 9. Thermo said that the planned divestiture of the Genevac business should “resolve any issues raised by the European Commission regarding the merger.”
Assuming the EC clears the transaction on Nov. 9, Thermo and Fisher plan to close the merger on that date.
Genevac is a vacuum pump manufacturer founded in 1990. Apogent Technologies acquired Genevac in 2000, and Apogent then merged with Fisher Scientific in 2004.
According to its website, Genevac employs around 85 people, and most are based at the company’s manufacturing, R&D, and marketing headquarters in Ipswich, UK.
Genevac also has a US subsidiary based in Valley Cottage, NY.
The Thermo-Fisher merger, which was announced in May, is expected to creat a life sciences behemoth with $9 billion in annual revenues, 7,500 sales people, and 350,000 customers worldwide (see BioCommerce Week 5/10/2006).
Bio-Rad Acquires Blackhawk Biosystems
Bio-Rad Laboratories this week said that it has closed its acquisition of Blackhawk Biosystems, a privately held maker of quality-control products for infectious disease testing.
Bio-Rad CEO Norman Schwartz said he expects this acquisition will help his company expand its online quality control and inter-laboratory peer group comparison.
Financial terms of the acquisition were not disclosed.
In the past year Bio-Rad also purchased ProteOptics and inked an agreement to acquire Ciphergen’s proteomic tools business, including the company’s SELDI platform, for $20 million in cash (see BioCommerce Week 8/16/2006).
GE Healthcare Q3 Revenues Rise 9 Percent
GE Healthcare last week said that third-quarter revenues climbed 9 percent as earnings increased 19 percent.
For the quarter ended Sept. 30, GE Healthcare generated $3.9 billion in revenues, up from $3.6 billion during the same quarter in 2005.
GE Healthcare's earnings for the quarter increased to $700 million from $589 million in the third quarter of 2005.
GE's total revenues for the quarter were $40.9 billion, up 12 percent from $36.4 billion during the same period last year.
GE did not break out its research and development expenses for the Healthcare segment.
As of Sept. 30, GE reported $59.4 billion in cash and marketable securities.
Thermo Electron, InforSense Sign Protein ID Software Pact
Thermo Electron signed a three-year OEM agreement to integrate its protein identification software with InforSense’s informatics framework, InforSense said last week.
The InforSense KDE platform will be integrated into Thermo Electron’s BioWorks package for proteomics data analysis.
Financial details were not disclosed.
Bruker BioSpin Sells First NMR System in US to MiamiUniv.
Bruker BioSpin last week said that Miami University is the first US customer for its Avance II 850 US2 NMR system, which will be delivered in 2007.
Miami University will use the 850 MHz NMR alongside a Bruker AXS Proteum X-ray protein crystallography system to study protein structures and complexes, ligand binding thermodynamics, and the metabonomics of biofluids.
Both systems will be used primarily by Michael Kennedy, whose research focuses on protein structure/function investigations in human disease.
Financial terms of the agreement were not disclosed.
Agencourt to Supply NuGen with RNA Purification Product
Beckman Coulter subsidiary Agencourt Bioscience will deliver its RNA purification product to NuGen Technologies as part of a newly signed OEM and supply agreement, the firms said this week.
NuGen said it plans to use Agencourt’s RNAClean in its WT-Ovation RNA amplification system.
Sue Pandey, vice president of commercial operations for NuGen, said her company likes Agencourt’s product because “it provides high recovery and can be easily automated in 96- and 384-well formats.”
No financial details of the deal were disclosed.
Enzo Biochem’s Q4 Revenues Drop 8.7 Percent; Licenses RNA Amplification Technology for Gene Expression Applications
Enzo Biochem last week reported an 8.7-percent decline in revenues atop a widened net loss for its fourth fiscal quarter.
For the quarter ended July 31, Enzo posted revenues of $9.9 million, down from $10.9 million in the year-ago period.
The company’s quarterly net loss more than doubled to $4.5 million from $2 million in the fourth quarter of 2005.
Enzo attributed the swelling net loss to a $900,000 increase in expenses, including a $500,000 increase in R&D expenses. The balance of the spending increase went toward litigation expenses and selling, general, and administrative expenses, the company said.
In its 10-K report filed with the US Securities and Exchange Commission, the company said that it would recognize $2 million from a recent settlement with Sigma-Aldrich in its first fiscal quarter for 2007, ending Oct. 31.
Enzo did not disclose its R&D spending for the quarter.
As of July 31, Enzo had cash, cash equivalents, and marketable securities of $69.9 million.
Enzo also announced last week that it has acquired a license from LBS Technologies to an RNA amplification technology for gene expression analysis.
The non-PCR based amplification process "allows researchers to increase amplification from relatively small RNA samples in gene expression studies," the company said in a statement.
The technology "is expected to impact favorably on usage and sales of our proprietary array amplification kits," Carl Balezentis, president of Enzo Life Sciences, said.
Enzo's license includes rights to six US Patents: Nos. 5,021,335; 5,168,038; 5,545,522; 5,716,785; 5,891,636; and 6,291,170.
The patent portfolio covers methods for amplifying the level of RNA in cells "to amounts that can produce gene expression patterns in microarrays and other applications," according to the Enzo statement.
Enzo said that the linear amplification technology offers benefits over exponential techniques, such as RT-PCR, because it maintains the relative ratios of the starting RNA population, "thereby allowing for more accurate expression profile studies."