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OraSure gets FDA nod for emergency use of rapid Ebola test

OraSure Technologies snagged the FDA's Emergency Use Authorization for its rapid Ebola test, a couple of months after the company got $10.4 million from the U.S. Department of Health and Human Services to develop its product.

Foundation Medicine trips in Q2 with sluggish test reimbursement

Foundation Medicine has been riding a wave of good fortune this year, striking a deal with diagnostics heavyweight Roche to bolster its industry footprint and accelerate product development. But the company hit a rough patch in Q2, with slower-than-expected reimbursement for its tests and results that missed the Street's expectations.

Johns Hopkins researchers unveil low-cost smartphone test for chlamydia

As the diagnostics industry zeroes in on rapid point-of-care tests, a team of scientists from the Johns Hopkins University is developing an innovative smartphone diagnostic for chlamydia that could improve screening for the disease.

R-Biopharm to develop companion diagnostic for Apogenix's cancer candidate

R-Biopharm will develop a companion diagnostic for Apogenix's lead anticancer candidate under an agreement the two just signed.

Bio-Rad Labs grabs FDA approval for next-gen HIV test

Bio-Rad Laboratories snagged FDA approval for its next-generation HIV Ag-Ab test for early detection of the virus. The Hercules, CA-based company's BioPlex 2200 HIV Ag-Ab assay distinguishes between HIV-1 and HIV-2 markers in human blood samples, making it the first diagnostic approved by the agency that can differentiate the infections.


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FiercePharma Manufacturing

An Ohio company has gotten FDA approval for its epilepsy drug Spritam, which it claims is the first to use three-dimensional printing technology. Aprecia Pharmaceuticals says the 3D process produces a formulation of levetiracetam that rapidly disintegrates with a sip of liquid, making it easy to ingest for those who have trouble taking medication.


Northwestern University announced that it has received a five-year, $17.5 million grant from the National Institutes of Health to study an implantable drug delivery system for the prevention of HIV. It's the latest application of drug delivery to solve the classic medical problem of adherence by developing a device that releases medication in a continuous and controlled manner for up to one year.