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Sequenom, ABI, Sigma-Aldrich, Millipore, Aruna, CombiMatrix, FDA, Roche, MDS Sciex, Waters, Abbott, Enzo Biochem

Sequenom’s Q4 Revenues Rise 80 Percent
Sequenom last week said fourth-quarter revenues increased 80 percent as R&D spending rose 33 percent and losses decreased 24 percent.
Total receipts for the three months ended Dec. 31, 2006, increased to $7.9 million from $4.4 million year over year. Sequenom said the jump in revenue was primarily driven by sales of its MassArray systems.
R&D spending increased to $4 million from $3 million year over year, due in part to “additional expenses associated with intellectual in-licensing and non-invasive prenatal diagnostic technology,” the company said.
Sequenom said losses declined to $5.3 million from $7 million in the year-ago period.
Sequenom said it had around $26.3 million in cash, cash equivalents, short-term investments, and restricted cash as of Dec. 31.
For 2007, the company said it expects annual revenues to grow to between $37 million and $39 million, or as much as 37 percent year over year. It also expects R&D costs to jump to between $16 million and $17 million, or as much as 42 percent over last year, and its net loss to swell to between $23 million and $25 million, or as much as 42 percent compared with 2006.

The company also said it expects to begin selling its non-invasive prenatal diagnostic for RhD incompatibility on RT-PCR as a home-brew test by the end of the second quarter. During the year, the firm expects to announce additional commercialization partnerships with CLIA-certified labs.

Sequenom said it is also currently developing the third version of its iPLEX assay, iPLEX III, which it plans to release by the end of the fourth quarter. The company said the platform will “reduce by half or more” the current $.035 cost per genotype for a typical study.

Finally, Sequenom said it expects to deliver by the end of the third quarter a proof-of-concept for intermediate-level fetal DNA enrichment, and a “commercially viable” product for fetal DNA enrichment for quantitative genomic tests such as CFTR or Tay-Sachs.


ABI Opens New Chinese Facilities, Collaborates with UK Veterinary Agency on Pathogen Detection Assays
Applied Biosystems has opened a new lab, office, and display space in Shanghai to support customers in the Asia-Pacific region, the company said this week.
ABI said the Asia Pacific Application Support Center is a 5,400 square foot facility that will house hardware for “biotech, health care, clinical research, forensic analysis and environmental and food safety testing.”
The center also aims to “enhance” collaborations with the Chinese government, including an association with the Ministry of Public Security, ABI said.
The company said the center will offer sample analysis, instrument and workflow demonstrations, training programs, and customer support services. ABI said it also intends to make the new facility available for scientific collaborations with research leaders in a variety of life sciences disciplines.
The firm said collaborations in China include a food safety and pesticide testing project; a forensic database with the Ministry of Public Security; donations of PCR instrumentation to the Chinese Center for Disease Control for SARS detection; and a collaboration with the China Proteome Project.
In a separate announcement last week, ABI said it plans to develop and market pathogen-detecting assay kits through a collaboration with the UK government’s Veterinary Laboratories Agency.
Under the agreement, ABI will build one test kit for avian influenza and one for Newcastle disease, ABI said. Both kits, which the company said are designed to help doctors detect bird-borne diseases, will be marketed widely in Europe, Asia, and Africa, but will not be available in the US.  
VLA will validate the assays, ABI said.
ABI said the VLA used the kits to confirm that the 2,600 turkeys that recently died in Suffolk, UK, were killed by the H5N1 strain of avian flu, and were subsequently used in a follow-up survey of the region’s population of wild birds.
Early detection allowed for a swift containment response in this case, the company said, adding that the goal of the collaboration is to make the assays available for “the same type of early warning detection in various countries.”
Financial terms of the agreement were not released.

Sigma-Aldrich Initiates $200M European Credit Facility
Sigma-Aldrich has initiated a $200 million credit facility in Europe that will mature in seven years, the company said this week.
The company said it will use the cash from the multi-currency revolving facility in its European operations for general purposes, including possible acquisitions.
Wells Fargo Bank, National Association, and the Bank of Tokyo-Mitsubishi UJF are co-leaders and bookrunners for a group of seven banks involved in the deal.

Millipore to Distribute Aruna’s Embryonic Neural Stem Cells
Millipore has licensed exclusive worldwide rights from Aruna Biomedical to market and distribute a line of human progenitor cells derived from NIH-registered human embryonic stem cells and media for neural research, the firms announced this week.
The stem cells will be sold under the ENStem brand name by Millipore and packaged in a kit with growth media and substrates. The partners anticipate the cells will be used for research in Alzheimer’s disease, spinal cord injury, and depression.
Financial terms of the deal were not disclosed.

CombiMatrix to Develop Autism Test Based on TCAG’s Biomarkers
CombiMatrix’s molecular diagnostics unit will create an array-based test using biomarkers linked to autism that were developed by the Center for Applied Genomics, the company said last week.
The company said it will use the markers through a partnership with TCAG in a constitutional genetic array test that will be used to screen for autism and “more than 50 disorders.”
One version of the test will be available sometime before the end of the month, and another version, to be created with TCAG, that uses the new autism indicators will be available at the end of the year, CombiMatrix said.    
Financial terms of the agreement were not released.

FDA to Review Roche PCR Test for HIV, Hepatitis in Donated Blood
The US Food and Drug Administration will review a Roche Diagnostics test designed to diagnose HIV and hepatitis infections in donated blood and plasma, Roche said last week.
The cobas TaqScreen MPX test is a real-time PCR-based single-multiplex assay that if approved would be used to detect HIV types 1 and 2 and hepatitis viruses C and B.
The tests would function on Roche’s cobas s 201 platform.

MDS Sciex’s Q4 Revenues Increase 1.5 Percent
MDS last week reported that first-quarter revenue for its Sciex division increased 1.5 percent, though organic receipts increased 4 percent.
Sciex’s total revenue for the three months ended Dec. 31, 2006, increased to $62 million from $61 million.
Driving revenue were the small molecule and applied markets and sales in Europe, MDS said.
MDS also said end-user revenue in the company’s joint ventures increased 10 percent.
R&D spending remained flat at $4 million.  
The company did not break out earnings or a balance sheet for the unit.
MDS is in the process of acquiring BCW Index firm Molecular Devices for $615 million (see BioCommerce Week 1/31/2007).

Waters Shares Rise on Upgrade
Shares in Waters closed up 4.9 percent, or $2.67, at $57.17 on Monday after being upgraded by an investment bank.
Earlier in the day, Robert W. Baird upgraded Waters’ stock to “outperform” from “neutral.”
The firm’s shares closed at $55.78 on Tuesday amid a broad sell-off in stocks on the US markets.

Court of Appeals Reinstates Injunction Against Abbott
Innogenetics last week said that a US federal appeals court has rejected a request by Abbott Laboratories to postpone an injunction prohibiting it from selling certain hepatitis C technology until the drug maker has had a chance to appeal the original verdict.

On Jan. 10, the US District Court for the Western District of Wisconsin permanently barred Abbott from selling, using, or exporting any products that infringe on Innogenetics’ US Patent No. 5,846,704, which covers a method of genotyping the hepatitis C virus.

Abbott filed an emergency motion to stay the injunction pending its appeal. On Jan. 19 the Federal Circuit temporarily stayed the injunction while it considered Abbott’s motion.
Last week, the US Court of Appeals for the Federal Circuit rejected the motion. The ruling reinstates the injunction against Abbott.
The decision “marks a positive first step in the appeal process and reinforces our belief that we will prevail in the court of appeals, just as we did at trial,” Innogenetics CEO Frank Morich said in a statement.
The ruling stems from a September 2005 suit Innogenetics filed against Abbott and Third Wave Technologies for allegedly infringing the ‘704 patent. While Third Wave and Innogenetics settled their suit, the court found that Abbott was infringing the IP, and the following year a jury unanimously said that the ‘704 patent was valid in all respects.
Last September, that jury unanimously found that Abbott’s infringement was willful and directed it to pay Innogenetics $7 million in damages.
On Jan. 4, the judge in this case dismissed Abbott’s requests for a new trial, affirmed the jury’s original finding, and approved the award of $7 million in damages.
However, the judge overturned the jury’s finding that Abbott’s infringement had been willful. On Jan. 10, the judge granted Innogenetics’ request to permanently bar Abbott from selling, using, or exporting any products that infringe on the ‘704 patent.
Innogenetics later filed an appeal to reinstate the jury’s willfulness finding, and Abbott appealed to stay the permanent injunction pending appeal.

Enzo Biochem Receives Favorable Judgment from USPTO in Nucleic Acid Case
Enzo Biochem last week said that the Board of Patents and Interferences of the US Patent and Trademark Office has judged in favor of its patent application for nucleic acid signal amplification over a pair of patents owned by Princeton University, after Princeton had conceded priority to Enzo.
According to Enzo, in an interference declared by the USPTO in August, Enzo was named the senior party and Princeton – which owns US Patent Nos. 4,882,269 and 5,424,188 – was named the junior party. Princeton had licensed the ‘269 patent to Chiron, which subsequently licensed it to Bayer Healthcare.
At the same time, the USPTO declared another interference involving the same technology, naming Enzo subsidiary Enzo Life Sciences the senior party against Chiron, the junior party, and Chiron’s US Patent No. 5,124,246, also licensed to Bayer. That interference is still pending, Enzo said.
“We believe this development further clarifies the historic accouint of which party first invented nucleic acid signal amplification technology,” Elazar Rabbani, Enzo’s chairmand and CEO, said in a statement.
The technology in question is the basis for several products in clinical diagnostics and life sciences marketed or licensed by several companies. Among these products are the Versant branched DNA assays sold by the diagnostics division of Bayer Healthcare, which was recently acquired by Siemens Medical Solutions.

The Scan

UK Pilot Study Suggests Digital Pathway May Expand BRCA Testing in Breast Cancer

A randomized pilot study in the Journal of Medical Genetics points to similar outcomes for breast cancer patients receiving germline BRCA testing through fully digital or partially digital testing pathways.

Survey Sees Genetic Literacy on the Rise, Though Further Education Needed

Survey participants appear to have higher genetic familiarity, knowledge, and skills compared to 2013, though 'room for improvement' remains, an AJHG paper finds.

Study Reveals Molecular, Clinical Features in Colorectal Cancer Cases Involving Multiple Primary Tumors

Researchers compare mismatch repair, microsatellite instability, and tumor mutation burden patterns in synchronous multiple- or single primary colorectal cancers.

FarGen Phase One Sequences Exomes of Nearly 500 From Faroe Islands

The analysis in the European Journal of Human Genetics finds few rare variants and limited geographic structure among Faroese individuals.