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FDA Warns LabCorp About ‘Misbranding’ on OvaSure
 
The Laboratory Corporation of America is facing regulatory action from the US Food and Drug Agency for misbranding an ovarian cancer detection test it developed with researchers from Yale University.
 
The FDA issued a warning letter to LabCorp on Sept. 29 stating that LabCorp’s OvaSure test is “not within the scope of laboratory-developed tests over which the agency has traditionally exercised enforcement discretion.”
 
The warning letter follows an Aug. 7 letter in which the FDA's Office of In Vitro Device Evaluation and Safety requested to meet with LabCorp to discuss the utility of OvaSure, which was developed at Yale University and launched in June, after it learned that the test's performance characteristics were based on results of a study that does not represent the intended treatment population.
 
Based on information collected by the FDA and data provided by the company at a Sept. 5 meeting, OIVD said it has determined that OvaSure is a test “designed, developed, and validated by investigators at Yale University and not LabCorp.”
 
Particularly, the FDA’s investigation has found that the instructions for use and the performance characteristics for the test were developed by Yale investigators. Furthermore, the agency found that certain materials associated with the tests were manufactured by another entity. The specific test parts and the manufacturer’s identity are stricken from the publicly posted warning letter.
 
In clinical studies, Yale investigators used protein arrays to identify six candidate biomarkers to assess early-stage ovarian cancer in high-risk women, including leptin, prolactin, osteopontin, insulin-like growth factor II, macrophage inhibitory factory, and CA-125. These biomarkers were incorporated into a multiplex immunoassay.
 
In its warning letter, the FDA identifies OvaSure as a device under section 201(h) of the Food, Drug, and Cosmetic Act intended for diagnosing or treating disease, and therefore requiring marketing clearance or approval from the agency. “Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the agency determined, calling the device “adulterated” and “misbranded” as a result.
 
Eric Lindblom, LabCorp’s senior VP of investor and media relations, told ProteoMonitor’s sister publication GenomeWeb Daily News that while the company is “disappointed about receiving the warning letter,” discussions are ongoing over possible next steps. “LabCorp shares the FDA's determination to help assure that patients are protected,” he said.
 
Last year, the FDA released a draft guidance explaining that in vitro diagnostic multivariate index assays are medical devices. Before this guidance, laboratory-developed tests, such as the OvaSure, were considered homebrews and overseen by the Centers for Medicare and Medicaid's less stringent CLIA rules.
 
LabCorp has 15 working days from receipt of the warning letter to present to the FDA its plan to correct the violations identified by the agency.
 
--Turna Ray
 

 
Invitrogen Files with EC for Acquisition of ABI, Says Synergies to Reach $80M in Year 1
 
Invitrogen said this week it has filed a formal notification with the European Commission in connection to its pending acquisition of Applied Biosystems.
 
The EC has 25 business days to respond to the filing. Invitrogen said it still anticipates the deal to close in November pending shareholder approval and EC approval. Invitrogen and ABI have scheduled shareholder meetings for Oct. 16 to vote on the transaction.
 
Separately, Invitrogen raised the amount of synergies it expects to achieve in the first year of the merger to $80 million from $60 million, mostly attributable to cost savings.
 
It also said that it has achieved a “significant milestone” in integration plans for its merger with ABI, by finalizing the synergy targets. The company has identified specific actions and timing “to achieve the synergies for all functions within the new company,” it said in a statement.
 
Invitrogen also said that third-quarter revenues will grow in the mid-teens year-over-year, including “several” points of growth due to foreign currency exchange. The company will release its full third-quarter results on Oct. 21.
 
The following day, ABI will release results for the first quarter of its fiscal 2009, which started on July 1. The company said this week that it expects the results to be in line with guidance issued in July when it projected revenue growth comparable to the 5.2 percent growth it posted in the first quarter of 2008.
 

 
Cellzome Receives Grant on Collaborative Study of Inflammatory Arthritis
 
Cellzome last week said it has received a Medical Research Council Pilot Industry Collaboration grant to use its Kinobeads technology to profile the expressed kinome in early inflammatory arthritis.
 
The collaborators on the grant are Christopher Buckley and Karim Raza in the department of rheumatology and Medical Research Council Centre for Immune Regulation at the University of Birmingham Medical School in the UK.
 
The project brings together three “novel” elements, the company and universities said in a joint statement: a cohort of well-characterized patients with very early inflammatory arthritis; refined ultrasound guided joint aspiration and biopsy; and the Kinobeads technology, a mixed kinase-inhibitor matrix.
 
With the ability to directly study the signatures of the expressed kinome in the early stages of arthritis, Cellzome hopes it will point to new targets for early therapeutic intervention, said David Simmons, CSO of the company, in a statement.
 
The Pilot Industry Collaboration Award was established by the UK Medical Research Council and MRC Technology to “encourage” research collaborations between MRC-funded researchers and industry.
 
The award is for two years. A company officially declined to reveal the amount.
 

 
World Fusion Becomes Ariadne’s Distributor in Japan
 
Ariadne this week announced that World Fusion is its new exclusive distributor in Japan.
 
World Fusion will also serve as support center for Ariadne’s MedScan technology and Pathway Studio product line.
 
Financial terms of the deal were not disclosed.
 
In a statement, Ilya Mazo, president of Ariadne, said World Fusion has been reselling his company’s products in Japan for more than four years. “Now with Pathway Studio version 6, our new generation product … we expect World Fusion will expand to the academic market,” he said.
 

 
Bio-Rad Moves to Big Board
 
Bio-Rad Laboratories announced this week it plans to move its stock to the New York Stock Exchange from the American Stock Exchange.
 
The company said it anticipates that trading on the NYSE will begin on or about Oct. 24. Its shares will continue to list under two ticker symbols “Bio” for Class A common stock, and “Biob” for Class B common stock.
 
The company did not give a reason for the switch, but the NYSE is considered the world’s largest exchange based on market capitalization. In a statement, Norman Schwartz, president and CEO of Bio-Rad said that its shareholders “will benefit from the NYSE’s brand, reputation, and trading efficiencies.”
 

 
Arrayit, BioSystems to Develop Microarrays for Human Plasma Proteins
 
Integrated Media Holdings said this week its wholly owned subsidiary TeleChem International, doing business as Arrayit, has entered into an exclusive microarray agreement with French firm BioSystems International.
 
Under the terms of the agreement, BSI will supply monoclonal antibodies that identify proteins expressed in human plasma. Arrayit will use its proprietary microarray manufacturing technology to print the antibodies onto glass slides. Arrayit will also market the slides. The first microarrays will be available in the fourth quarter of 2008, Arrayit, based in Sunnyvale, Calif., said in a statement.
 
Each party will fund the R&D startup and eventually share revenues. No further financial details were released.
 

 
Power3 Anticipating Launch of Dx Tests
 
Power3 Medical Products this week said it is on the cusp of commercialization of its diagnostic tests for breast cancer, Alzheimer’s disease, and Parkinson’s disease, and expects revenues from sales and licensing of the tests this quarter.
 

The initial launch of the tests, BC SeraPro and NuroPro, is expected to be in Greece where Power3 and the University of Thessaly have been performing clinical validation of the company’s neurodegenerative tests, said Ira Goldknopf, president and CSO of Power3.

The Scan

Review of Approval Process

Stat News reports the Department for Health and Human Services' Office of the Inspector General is to investigate FDA's approval of Biogen's Alzheimer's disease drug.

Not Quite Right

A new analysis has found hundreds of studies with incorrect nucleotide sequences reported in their methods, according to Nature News.

CRISPR and mRNA Together

Time magazine reports on the use of mRNA to deliver CRISPR machinery.

Nature Papers Present Smartphone Platform for DNA Diagnosis of Malaria, Mouse Lines for Epigenomic Editing

In Nature this week: a low-cost tool to detect infectious diseases like malaria, and more.