Noninvasive metastatic cancer test firm raising Series A ahead of pilot clinical trial

Updated to include that the filing indicates only the initiation of fundraising, which will continue beyond the disclosed amount.

Other companies have developed blood tests to detect rare circulating tumor cells in patients with metastatic cancer, but a startup called IVDiagnostics Inc. is testing a system that does it in real time and in-vivo, eliminating the need for blood draw.

The company has already raised $86,000 and is continuing to raise funds for a pilot trial of its platform in breast cancer and nonsmall cell lung cancer patients in the third quarter of this year, followed by a pivotal trial in one of those cancer types with twice as many patients, according to CEO Frank Szczepanski.

The IVDxTx platform detects CTCs that are tagged with a nontoxic, fluorescent probe injected into the patient with a syringe. An optical scanner held over a peripheral vein for about 20 minutes “reads” those CTCs and collects data that is then processed by proprietary software, which generates a real-time report on CTC counts based on 1 liter of blood.


With improved sensitivity and specificity over standard blood tests, it will allow doctors to diagnose cancer more accurately, monitor the effectiveness treatment and predict disease recurrence after treatment, the company says.

Tumors with high percentages of nonlocalized metastases — like breast, colon, kidney, leukemia, lung, ovarian and pancreatic — are the targets of IVDiagnostics’ assays.  With additional R&D, the company could use this platform for noninvasive monitoring of other types of blood-borne diseases, it says.

Researchers have been developing different methods of detecting CTCs (using nanoparticles, photoacoustics and micromagnetics, for example) for a while now, and the U.S. Food and Drug Administration has approved some tests, like Veridex’s CellSearch system and GeneSearch Assay. But there will be continued opportunity for improvements in diagnostic testing as the global oncology market grows to an estimated $76.7 billion by 2014, according to life science consulting company Farmantra.

Founded in 2008, IVDiagnostics is located in Valparaiso, Indiana and has just opened a second office at Purdue Research Park of Northwest Indiana.

[Photo from IVDiagnostics]

No comments