A Diagnostics & Imaging Week
XDx (Brisbane, California) has filed a registration statement with the Securities and Exchange Commission for a proposed IPO valued at up to $86.25 million, with the number of shares and pricing to be determined.
The company said it may use a portion of the proceeds to acquire or invest in complementary businesses, technologies, services or products.
XDx is a molecular diagnostics company developing noninvasive gene expression-based tests for monitoring transplant rejection and autoimmune diseases.
In January 2005 the company launched its first test, the AlloMap LTx molecular expression test, to monitor for acute cellular rejection in lung transplant recipients. It also is designing a clinical study to create a gene expression test to monitor for disease flares in patients affected by systemic lupus erythematosus.
It said it intends to pursue tests to monitor other immune-mediated conditions with unmet medical needs.
The company also makes the AlloMap HTx test, an objective, multi-gene molecular diagnostic test that measures the level of gene expression in a processed blood sample to help determine whether a heart transplant recipient is rejecting the transplanted heart. The company believes the use of its test, in conjunction with other clinical indicators, may help physicians and patients avoid unnecessary surveillance biopsies and may help physicians determine whether the dosage of potentially harmful immunosuppressive drugs could be reduced.
The company said in its filing that it has incurred substantial net losses since its inception, and expects to continue to incur additional losses in future years. For the years ended Dec. 31, 2004, 2005 and 2006 and the six months ended June 30, it had a net loss of $13 million, $16.6 million, $19.9 million and $11.8 million, respectively. From its inception through June 30, it has an accumulated a deficit of $78.4 million.
The company also noted the FDA recently issued draft guidance on certain laboratory-developed tests, (LDTs) that the agency has termed “In Vitro Diagnostic Multivariate Index Assays” or IVDMIAs. This draft guidance classifies LDTs that are dependent on an interpretation algorithm as medical devices. Because the AlloMap HTx test utilizes an interpretation algorithm, the company believes it is likely that its test will meet the definition of IVDMIA and, as a result, if the draft guidance is finalized, it is likely that the AlloMap HTx test and future company tests would become subject to FDA regulation as medical devices.
J.P. Morgan Securities and Morgan Stanley & Co. are acting as joint book-running managers, with Piper Jaffray & Co. and JMP Securities acting as co-managers.
XDx said it intends to apply to have its common stock approved for listing on the Nasdaq Global Market under the symbol XDXI.
In other financing activity:
• HistoRx (New Haven, Connecticut) reported that it has secured $6 million in a Series B private equity financing round, led by current investor Brook Venture Partners.
The company said it will use the funds to advance development and commercialization of its portfolio of tissue-based diagnostic products developed from the company’s patented Aqua biomarker analysis platform.
“These funds provide the resources necessary to move our product portfolio of diagnostic tests through later-stage development, FDA approval, and commercialization,” said Rana Gupta, CEO of HistoRx.
HistoRx partners with pharmaceutical and biotechnology companies to generate precise and cost-effective answers about the safety and effectiveness of targeted therapeutics in development for cancer and other diseases. These partnerships provide the foundation for the company to develop companion diagnostic tests that will be co-marketed with partners’ targeted therapeutics. HistoRx also pursues internal programs to develop diagnostics that will enable improved treatment decisions in cancer care.
In addition to Brook Venture Partners, participants in the financing included another Series A investor, Navigator Technology Ventures, as well as three new investors: The Roche Venture Fund, Commons Capital, and Maven Capital.