CombiMatrix Molecular Diagnostics Receives CLIA Certification
CombiMatrix Molecular Diagnostics has received CLIA certification to operate as a clinical laboratory, the company said last week.
Matt Watson, CEO of CMDX, said his company had been working to establish processes and procedures that would meet quality control and quality assurance standards in line with CLIA since the company was founded in May 2005 (see BAN 5/11/2005).
CMDX is a wholly owned subsidiary of CombiMatrix, which is a unit of Acacia Research.
The company plans to launch its first service using its own array comparative genomic hybridization technology to diagnose constitutional changes in patients later this month (see BAN 3/28/2006).
Separately, software supplier Infotrieve said this week that CMDX has adopted its Electronic Laboratory Notebook for the management of scientific protocols, data collection and data sharing.
The Infotrieve/ELN is an enterprise-wide electronic laboratory notebook software solution designed to collect, store, analyze, and share data among biologists, Infotrieve said.
Almac Diagnostics Licenses Rosetta's Resolver System
Almac Diagnostics has licensed Rosetta Biosoftware's Resolver system to help it develop microarray-based approaches for diagnosing cancer and predicting therapeutic outcomes, the companies said last week.
The company will also use the technology "in the provision of comprehensive gene expression analysis services" Almac offers to academic, biotech, and pharmaceutical customers.
Almac, formerly ArraDx, is a member of Affymetrix's Powered by Affymetrix diagnostics program, which enables independent companies to develop diagnostics based on Affy's GeneChip platform (see BAN 1/10/2006).
The Rosetta Resolver system is developed and supported by Rosetta Biosoftware and is distributed exclusively by Agilent Technologies.
Solexa to Phase Out MPSS Activities This Year
Solexa plans to discontinue its activities involving Lynx's legacy Massively Parallel Signature Sequencing technology this year, Solexa said in an SEC filing last week. Solexa also said it is renegotiating with MPSS customers to provide them with services based on the company's Sequencing-by-Synthesis chemistry.
This is the first time that Solexa has been specific about when it plans to phase out the MPSS technology it inherited from Lynx. Last May, Solexa CEO John West told BioArray News that the company would continue to offer MPSS through the launch of the SBS-Cluster analysis system, and that it would encourage MPSS customers to switch over time. At that time, Solexa did not provide a timeline on the change (see BAN 5/25/2005).
ExonHit, BioMérieux Move Forward in Breast Cancer Dx Project
ExonHit Therapeutics and bioMérieux said last week that they have made progress in their plans to develop a blood-based in vitro diagnostic for early-stage breast cancer, and that they have initiated a multi-center study involving 1,000 women to validate their biomarkers.
According to bioMérieux and ExonHit, the company's used ExonHit's splice variant microarrays to identify and validate biomarkers associated with early stage breast cancer. The companies said that their data shows that the panel of genetic signatures can distinguish healthy women from those with early-stage breast cancer. ExonHit and bioMérieux pointed to a specific study where a total of 54 genes were able to correctly classify, with accuracy of 87 percent, a group of 92 women, where 55 had breast cancer and 37 did not.
The companies said that their work could lead to the development of diagnostic tests that will enable the early detection of breast cancer from blood and could enable clinicians to make a better therapeutic decision more quickly.
The ExonHit and bioMérieux collaboration in breast cancer diagnostics was initiated in 2003. Four more diagnostic areas were added in 2005 when the companies signed a second, six-year deal (see BAN 10/19/2005).
Nanogen Receives FDA Clearance for Congestive Heart Failure Test
Nanogen said last week that it has won 510(k) clearance from the US Food and Drug Administration to sell its test for congestive heart failure
The diagnostic, called StatusFirst CHF NT-proBNP EDTA plasma test, is used to diagnose individuals suspected of having the condition. It is the first 510(k) clearance for Nanogen.
Nanogen said it will continue developing its StatusFirst CHF test that evaluates whole blood samples with an eye for FDA clearance.
The cleared test is the result of a joint effort by Nanogen and Princeton BioMeditech. The companies co-developed the test and PBM will manufacture the product under contract with Nanogen, it said. The test is sold in conjunction with the DXpress reader, a qualitative and quantitative instrument supplied by PBM.
NIH Awards UPenn $3.2M for Musculoskeletal Disorders Center
The University of Pennsylvania School of Medicine has been awarded a five-year, $3.2 million grant from the National Institutes of Health to create the Penn Center for Musculoskeletal Disorders, UPenn said last week.
According to UPenn, the new center is one of five such centers nationally and has been founded to support three critical, innovative research Cores to enhance musculoskeletal research, including a microarray core, which UPenn said will enable investigation of musculoskeletal disorders on the genetic level through RNA transcript profiling.
A structure-function biomechanics core, which will develop and utilize a wide range of functional, mechanical, and structural assays of musculoskeletal tissue injury and repair, as well as a small animal imaging core, which will develop and use extensive imaging techniques to detect, evaluate, and treat problems of musculoskeletal injury and repair, are also planned.