This Week In Diagnostics

Clinical trial initiated for Trisomy 21 test
Aria Diagnostics (formerly Tandem Diagnostics) says that it is initiating a multicenter clinical trial that compares its non-invasive prenatal test with the standard first-trimester screening test (serum screening and nuchal translucency ultrasound alone and in combination) to detect Trisomy 21, which is associated with Down syndrome. Aria’s test, which is currently in development, uses a directed, non-invasive approach to cell-free DNA (cfDNA) analysis in maternal blood for evaluation of common fetal trisomies linked to genetic disorders. In addition, the NEXT (Non-Invasive Chromosomal Examination of Trisomy) study will help define for healthcare providers the optimal clinical testing practice for first trimester testing. Researchers are enrolling 25,000 women, ages 18 years or older, who are pregnant with one fetus and planning a hospital delivery. Blood samples will be collected between 10 and 14 weeks, and those receiving the standard first-trimester screening will also receive a nuchal translucency measurement performed via ultrasound. Unlike previous clinical trials involving cell-free DNA analysis, the complete pregnancy will be followed, including newborn medical records following birth.

Hologic to purchase Barcoded Magnetic Beads
Applied BioCode reports that it has signed a license and supply agreement with Hologic that allows them to purchase the company’s Barcoded Magnetic Beads (BMB) with digital multiplex capabilities. Hologic says that it plans to use the BMBs in conjunction with its Invader® chemistry to create nucleic acid based tests for the agriculture market.

Health Discovery and NeoGenomics collaborate
Health Discovery (OTCBB: HDVY) and NeoGenomics (OTCBB: NGNM) say that they have entered into a licensing agreement for the development of laboratory developed tests (LDT’s) in the field of hematopoietic and solid tumor cancers excluding breast cancer, which was previously licensed to Quest Diagnostics (NYSE:DGX) and Smart Personalized Medicine and excluding cancer of the retina, which was previously committed to Retinalyze, LLC. HDC will retain all rights to in-vitro diagnostic test kit development in cancer. NeoGenomics has paid $1 million in cash and issued 1,360,000 common shares to HDC in upfront licensing fees. In addition, NeoGenomics will make milestone payments, in cash or stock, based on sublicensing revenue and revenue generated from products and services developed as a result of the collaboration.

In Brief…
Agilent Technologies and Integrated Diagnostics say that they have struck a strategic partnership to develop assays that detect major human diseases at very early stages to improve treatment outcomes. The partnership will develop high-throughput automated workflows to include sample preparation and LC MS/MS analysis. The technology opens the possibility of screening for several hundred biomarkers in a single assay, in a very high-throughput and quantitative fashion, according to Agilent.

Exagen Diagnostics has announced the launch of its Avise SLE, which aids in the diagnosis of lupus. Avise SLE is a 5-marker panel that includes testing of ANA, dsDNA, Avise MCV, EC4d and BC4d. The Avise SLE diagnostic differentiates itself by using cell-bound complements because of their increased performance over soluble complements.

Dako reports that it will develop a companion diagnostic test for an Amgen cancer drug candidate targeted for a rare and deadly cancer.

The G2 Molecular Diagnostics Conference will be held in Boston April 17-19, 2012. Details: www.mdxconference.com-Peter Winter