• Abbott (Des Plaines, Illinois) received a supplemental premarket approval from the FDA for its recently introduced RealTime HIV-1 viral load test. The approval allows Abbott to market a number of enhancements to the test, including a new design feature that will give laboratories the flexibility to perform HIV-1 viral load tests with smaller amounts (0.6 mL) of blood plasma. Abbott markets the m2000 system and a menu of tests throughout the world as part of a strategic alliance with Celera (Rockville, Maryland). The RealTime test, based on real-time polymerase chain reaction (PCR) technology, is the most sensitive HIV-1 viral load test available and the only test of its kind validated to detect and quantitate (precisely measure) the common strains of HIV-1 as well as all known genetic variations of the virus, including group O, group N, and non-B subtypes. The assay has a broad range, capable of quantitating HIV-1 in plasma down to as few as 40 RNA copies per mL, surpassing the standard of care in diagnostic sensitivity of 50 copies per mL. The test targets the highly conserved pol integrase region of the HIV-1 genome, giving the test its ability to detect and measure all known genetic variations of the virus.

• Invitrogen (Carlsbad, California) reported the launch of a new disposable device to simplify manual passaging, the process of dividing human embryonic stem cell (hESC) colonies. The tool, Stempro EZPassage, can reduce the time required for this crucial step in stem cell research, improve the uniformity and consistency of manual passaging and decrease the amount of training required for newcomers to the field. The ability to self renew and continually divide is a main characteristic of embryonic stem cells. Cells replicate in culture, form colonies, and eventually outgrow the dish in which they were placed. Researchers must then “passage” the cells to a new dish to allow them to continue growing. Current manual and enzymatic passaging processes are labor-intensive, can take more than 20 minutes, and result in passaged colonies of non-uniform size. By contrast, the passaging process with Stempro EZ Passage can take less than a minute, and the resulting stem cell sub-colonies are uniform. In addition, unlike traditional methods, no extensive training is required for using the Stempro EZ Passage. Invitrogen is a provider of essential life science technologies for research, production and diagnostics.

• Vyteris (Fair Lawn, New Jersey) reported the commercial availability of LidoSite to the 40 million American patients in physician offices who are needle-averse or even needle-phobic. With close to one billion blood draws taken a year in the U.S., according to a study by market research firm TVG, it is estimated that each year about 40 million American patients experienced “high discomfort” with blood draws due to needle pain. An overwhelming majority of the surveyed patients who experienced “high discomfort” — 65% indicated they intended to use or ask for LidoSite at their next blood draw — representing an initial potential U.S. market for LidoSite of 26 million patients annually for this segment alone. LidoSite is the first active transdermal patch approved by the FDA to deal with pain associated with blood draws (venipuncture) IV (intravenous) cannulations and laser ablation of superficial skin lesions. The device uses the process of iontophoresis to carry a combination of the local anesthetic lidocaine and vasoconstrictor epinephrine, which localizes the anesthetic effect, from a patch through the skin layer and into the underlying tissue by way of a mild electrical current. LidoSite is composed of a heart-shaped controller that houses a microprocessor regulating dosing of medication, intervals and duration of dosing and is good for up to 99 patch applications. Vyteris’ active transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy.