• American Bio Medica (ABMC; Kinderhook, New York) said that it has begun the manufacturing of diagnostic test strips for Syphilis for Hema Diagnostic Systems (HDS; Miami Beach, Florida), a private manufacturer of rapid diagnostic tests for infectious diseases. HDS will incorporate the ABMC Syphilis test strip into HDS’ Rapid 1-2-3 Hema Express delivery system. The Express is a patent pending device that provides a simple, efficient and cost effective method that allows testing at the point of care. The express uses incorporating a simple, pre-marked series of lines on the sample pad, which is used to clearly identify when sufficient blood has been taken up onto the pad. This feature aids in eliminating guesswork and ensures reliable, repeatable test results. American Bio Medica makes accurate, cost-effective immunoassay diagnostic test kits, including point of collection tests for drugs of abuse.

• Illumina (San Diego) reported that scientists at the company have sequenced the genome of an anonymous African male (Yoruba from Ibadan, Nigeria), using the Genome Analyzer. Sequencing of this HapMap sample was conducted internally and marks the first human genome sequence generated exclusively with paired reads of 35 to 50 bases in length. Leveraging recent system improvements that increase the throughput and improve the accuracy of the Genome Analyzer, Illumina scientists were able to complete this project in a matter of weeks. More than 95% of production runs generated high-quality data with an average of over three billion bases (three Gb) per run. This achievement establishes the direct utility of Illumina’s sequencing technology for accurately sequencing large and complex genomes. Using paired reads primarily from 200 base pair (bp) insert size libraries, supplemented with reads from 2000 bp insert size libraries, Illumina scientists initially conducted 27 runs to generate over 75 Gb of DNA sequence and achieve more than 90 percent coverage of the genome. An initial analysis yielded over 3.7 million single nucleotide polymorphisms (SNPs), including more than one million novel SNPs. Illumina makes life-science tools and integrated systems for the large-scale analysis of genetic variation and biological function.

• T2 Biosystems (Cambridge, Massachusetts) reported research findings that support the advancement and development of nanoparticle-based, MR technology that offer rapid, portable diagnostic testing. This research, it said, demonstrates new methods of advancing and developing MR-based diagnostics that offer improved speed, accuracy and efficiency as well as portability to a broader range of settings including doctor’s offices, homes and hospitals. These findings show the feasibility of T2’s portable diagnostic system, building on prior published research studies demonstrating the ability of the nanoscale MR-based technology to detect target substances in diagnostic tests, including small molecules, single viral particles, bacteria and cancer biomarkers. T2 biosystems makes portable diagnostic products.

• Volcano (San Diego) reported FDA clearance of the s5-Revo and s5-FFR (fractional flow reserve) options. These two new product offerings now enable rotational IVUS and FFR to operate on the same integrated Volcano s5 imaging system as Volcano’s previous line of phased array IVUS catheters and functionality. For the first time, physicians can choose among three powerful diagnostic tools — all on the same integrated IVUS platform. Earlier generation consoles included only one of the three technologies now available on the s5. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. The Volcano s5 can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple digital IVUS, and pressure-based FFR guidewires) on a single platform. Volcano specializes in intravascular ultrasound and functional measurement technology.

• Welch Allyn (Skaneateles Falls, New York) reported introduction of its Digital MacroView Otoscope, a hand-held video otoscope with USB connected, plug-and-play capabilities that offers clear, live and still images of the ear canal and tympanic membrane—improving communication and patient compliance. The Digital MacroView Otoscope has the ability to focus the image for clear views, comes equipped with an insufflation port for pneumatic otoscopy, and works with all existing Welch Allyn 3.5V power sources.