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Bio-Rad, FDA, Chicago Community Trust, Applied Biosystems, Stanford, University of Miami, Becton Dickinson, Clontech

Bio-Rad Gets FDA Nod for Automated Immunoassay Platform and Rapid HIV Antibody Detection Assay

Bio-Rad Laboratories received two FDA clearances in early January, getting agency approval to market its BioPlex 2200 automated immunoassay platform, and a rapid test to detect HIV antibodies.

The BioPlex 2200 system, which was introduced at the American Association of Clinical Chemistry meeting in July and will roll out early this year, is an automated bead-based multiplexing clinical diagnostics technology and informatics product that can produce up 2,200 results per hour and can analyze multiple disease states from single-patient samples. The system will initially include a panel of assays targeting autoimmune diagnostics, the company said in a statement.

“This unique system will improve the quality of patient testing, decrease turnaround time and eliminate the traditionally labor-intensive processes involved in specialty diagnostics, John Goetz, vice president of Bio-Rad’s Clinical Diagnostics Group,” said in a statement.

Additionally, the FDA’s Center for Biologics Evaluation and Research approved Bio-Rad’s premarket approval application for its Multispot HIV-1/HIV-2 Rapid Test, an assay for the detection of HIV-1 and HIV-2 antibodies in human plasma and serum. The assay is not approved for use in screening blood, plasma, cell, or tissue donors, however. Additionally, Bio-Rad will have six months to conduct additional tests against potentially interfering substances, the FDA said in a statement.

Bio-Rad said it expects to make the test available this month.

In preparing for the approval and the roll-out of the BioPlex platform, Bio-Rad increased its research and development budget 15 percent to $26.6 million, the company said in an SEC filing. Development tasks included the creation of diagnostic test panels, and software data-management product offerings for its quality-control product line.

The is developing BioPlex assays in the areas of serology, infectious disease, cardiology, and toxicology.

Chicago-Based Proteomics/Bioinformatics Project Receives $1.95 Million in Funding

The Searle Funds at the Chicago Community Trust have awarded $1.5 million to the Chicago Biomedical Consortium for a proteomics/bioinformatics demonstration project, the University of Illinois at Chicago, the University of Chicago, and Northwestern University said this week.

The universities have also agreed to contribute an additional $150,000 each to the project.

According to the universities, the proteomics/bioinformatics project is the CBC’s first initiative, and will join “experimentalists, instrumentalists, and informaticians to apply new technology and new analytical techniques to addressing the basic questions of proteomics.”

Researchers working under the project will have access to a Fourier transform mass spectrometer, the universities noted. The FTMS is expected to be in place by the summer, but before then research teams and computational resources will be established to analyze the large amounts of data expected to come out of the proteomics/bioinformatics effort.

The universities noted that the FTMS would be available to all researchers throughout the Chicago area, not just those at the UIC, the University of Chicago, and Northwestern University.

ABI Expands Biomarker Collaboration With Stanford, University of Miami

Applied Biosystems has expanded an ongoing collaboration with researchers at Stanford University and the University of Miami to further study lymphoma biomarkers, the company said this week.

In the new studies, the scientists will use ABI’s TaqMan Low Density Array, a microfluidic card for real-time PCR, to validate the predictive value of six gene-expression based markers associated with treatment response and survival in diffuse large B cell lymphoma, the most common form of non-Hodgkin’s lymphoma.

The initial study was published last April in an article in the New England Journal of Medicine entitled “Prediction of survival in diffuse large B-cell lymphoma based on the expression of six genes.” For this study, the researchers used a combination of microarrays, bioinformatics, real-time PCR, and TaqMan gene expression assays, ABI said.

Becton Dickinson Gets 510(k) FDA OK For BBL Chromagar Bacteria Testing Device ...

Becton Dickinson has received US FDA 510(k) approval for its BBL Chromagar device, which is designed to test for some strains of antibiotic-resistant Staphylococcus aureus bacteria. Becton said its test can identify methicillin-resistent staph bacteria within 24 hours.

... And says Clontech will be sold in Q2 or Q3; Buyer Remains Undisclosed

Becton Dickinson expects to complete the sale of its Clontech division in the second or third quarter..

“The process is moving ahead according to schedule,” Vince Forlenza, president of BD Biosciences, said at the JPMorgan Healthcare Conference, held here this week.

The buyer remains undisclosed.


The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.