FDA Asks Correlogic to Meet On Marketing of Ovarian Cancer Test
Steve Gutman, the director of the US Food and Drug Administration's Office of In Vitro Diagnostics, has asked Correlogic Systems to discuss the marketing of the company's test for predicting ovarian cancer, GenomeWeb News, SNPtech Pharmacogenomics Reporter’s sister publication, has learned.
In the letter to company president Peter Levine, which is dated Feb. 18, Gutman said the test is a device and may be subject to the agency's premarket review requirements. Click here to read the letter.
The test, called OvaCheck, was developed by Correlogic and scientists at the National Cancer Institute and the FDA, and is licensed to clinical lab giants Quest Diagnostics and LabCorp.
The letter comes on the heels of a similar one sent by Gutman’s office to Roche Diagnostics last summer. That letter ultimately caused Roche to scuttle its attempt to sell its AmpliChip cytochrome P450 array as an ASR in the United States [see 11/6/03 SNPtech Pharmacogenomics Reporter].
Transgenomic Sees Q4 Revenues Decline; Negotiates $2.75 Million Convertible Note
Transgenomic this week reported a 7-percent decline in fourth-quarter revenues amid lower R&D spending and narrowed net losses. The company also reported dwindling cash reserves.
Total revenue for the three months ended Dec. 31 contracted to $8.5 million from $9.2 million one year ago.
The company spent $2.2 million on R&D during the quarter, down 33 percent from $3.3 million in the fourth quarter of 2002.
As a result, fourth-quarter net loss, which included a goodwill impairment charge of $4.8 million, shrank to $8.5 million, or $.32 per share, from $9.3 million, or $.40 per share, in the fourth quarter of 2002. The Q4 2002 number included a $3.3 million charge. Transgenomic said it had around $1.2 million in cash, cash equivalents, and short-term investments as of Dec. 31.
CFO Michael Draper said that the company has abandoned its previous plans to improve its liquidity position, which involved a sale-and-leaseback transaction related to its Glasgow, Scotland, manufacturing facility.
Instead, the company will broaden a $7.5 million credit facility it established with Laurus Master Fund in December to include a three-year, $2.75 million convertible note. Draper said the arrangement "is preferable to the sale and leaseback options available" and "will be adequate to support our operations," based on current projections.
Lark Technologies Shareholders to Vote On Genaissance Acquisition April 1
Lark Technologies stockholders on April 1 will decide whether to agree to the proposed acquisition of their company by Genaissance Pharmaceuticals, the company said last week. New Haven, Conn.-based Genaissance announced its plan to acquire Lark, based in Houston, in December [see 1/1/04 SNPtech Pharmacogenomics Reporter].
OpGen, Detroit Lab to Study Brain Tumor DNA
OpGen will use its optical-mapping technology to help the Hermelin Brain Tumor Center study oligodendrogliomas, the groups said last week.
OpGen said it has begun an optical mapping study of the tumor that is aimed at helping researchers at Detroit-based Hermelin identify lesions in a tumor’s genome “to determine what is happening at the DNA level and how well a patient will respond to treatment.”
According to Oliver Bogler, an associate scientist at the Hermelin Center, deletions on chromosome 1p and 19q of the tumor “correlate strongly with response to a range of therapies,” and that “it is crucial to understand the nature of these rearrangements.”
“The fact that these deletions affect response to such different treatments, including various drug combinations and radiotherapy, indicates that something fundamental is going on here, and understanding these events could be crucial in developing new treatments for this, and possibly other lethal cancers,” Bogler said in a statement.
Paradigm Genetics Reports Strong Q4 Revenues, Narrowed Loss in Q4
Paradigm Genetics last week reported improved revenues and considerably narrowed losses for the fourth quarter of 2003.
Total receipts for the period ended Dec. 31 increased to $5.5 million from $1.9 million during the fourth quarter of 2002.
R&D expenses for the quarter increased to $6 million from $5.7 million in the year-ago period. Net losses, meantime, shrank to $2.2 million, or $.07 per share, from $9.3 million, or $.29 per share, year over year. As of Dec. 31, Paradigm had $10.2 million in cash, cash equivalents, and short-term investments.
TherImmune’s Receipts Help Buoy Gene Logic’s Q4 Revenue
Gene Logic last week reported an increase in total fourth-quarter revenue, but if the company hadn’t acquired TherImmune Research, its revenues would have fallen around $1 million.
Revenues for the three months ended Dec. 31 increased to $19.7 million from $14.8 million one year ago, largely on the shoulders of the $5.8 million generated by TherImmune Research, which Gene Logic acquired last April. Without the acquisition, Gene Logic’s revenue for the fourth quarter 2003 would have been $13.9 million compared with $14.8 million for the same period one year ago.
R&D costs decreased to $500,000 from $800,000 during the same quarter a year ago, while net loss decreased to $4.9 million, or $.16 per share, from $5.2 million, or $.19 per share, during the fourth quarter a year ago. As of Dec. 31, Gene Logic had approximately $111.8 million in cash, cash equivalents and marketable securities available-for-sale. This includes $48.7 million in cash and cash equivalents.
Separately, Gene Logic said that Boehringer Ingelheim has renewed its license to Gene Logic’s GeneExpress information services for several years.
Third Wave Posts Q4 Revenue Growth, Widened Net Loss
Third Wave Technologies this week reported increased revenues amid greater R&D spending and a widened net loss.
Total receipts for the period ended Dec. 31 increased to $9.7 million from $7.6 million during the same time a year ago.
R&D expenses also increased, to $3.8 million from $3.3 million during the year-ago period. As a result, fourth-quarter net loss grew to $1.6 million, or $.04 per share, from $500,000 million, or $.01 per share, during the same period in 2002. As of Dec. 31, the company had cash, cash equivalents, and short-term investments of $57.8 million.
Biotage (Once Pyrosequencing) Expects Strong Q4 Revenue Growth
Biotage, which changed its name from Pyrosequencing late last year, said it expects fourth-quarter 2003 sales to have increased and net loss to have narrowed.
Total receipts for the three-month period ended Dec. 31 jumped to 105 million Swedish kronor, or SEK ($14.5 million), from SEK34 million one year ago, the company said in an interim fourth-quarter earnings report. The report, which was not comprehensive, also said net loss would decrease to SEK 31 million from SEK44 million in the same period one year ago.
The new company was created when Pyrosequencing bought US-based Biotage [see 10/30/03 SNPtech Pharmacogenomics Reporter] in October 2003 for around $30 million.
Agencourt Biosciences Launches Genomics Research Training Program for Minorities
Agencourt Bioscience has established a post-baccalaureate training program for underrepresented minorities in genome sciences. The company launched the two-year program as part of a three-year, $28 million NHGRI Large-Scale Sequencing Center award it received last November. Applications will be accepted until March 15, and the program will begin in July.
CombiMatrix to Team With Case Western Researchers to Develop Alzheimer’s Dx …
Acacia Research group subsidiary CombiMatrix will collaborate with researchers at Case Western Reserve University to develop a diagnostic test for Alzheimer’s disease, the company said this week.
The university scientists, led by Mark Smith at the Department of Pathology, will use CombiMatrix’s CustomArray microarray platform in their research.
… As Company Posts Strong Q4 Revenue Growth, Wider Losses
Acacia Research unit CombiMatrix last week reported a surge in fourth-quarter revenue atop tighter R&D spending and a significantly narrowed net loss.
Total receipts for the period ended Dec. 31 jumped to $53,000 from $16,000 one year ago. From this, revenue from product sales increased to $27,000 from $9,000 year over year, and receipts from grants or contracts increased to $26,000 from $7,000.
The company’s recorded revenue does not include $1.4 million in cash payments from a partnership agreements with Toppan, which the company recorded as deferred revenue.
R&D spending in the fourth quarter fell to $1.9 million from $4 million year over year. As a result, net loss for the division dwindled to $4 million from $21.4 million for the same period last year. CombiMatrix said it had around $17.3 million cash, equivalents, and short-term investments as of Dec. 31.