Cardiac Status line includes four FDA-cleared tests that can be used at the point-of-care to determine elevations of cardiac markers, diagnose acute coronary syndrome (ACS) as indicated by chest pain
Nanogen has completed the acquisition of the rapid cardiac immunoassay test business from Spectral Diagnostics.
The deal expands Nanogen's portfolio of complementary diagnostics to include Spectral's Cardiac Status and Decision Point product lines, the i-Lynx reader, related intellectual property and manufacturing capabilities.
Nanogen now has a fully integrated point-of-care group with resources and capabilities in research, product development, manufacturing, and sales and marketing with a worldwide distribution network to compete in the $1.5 billion worldwide point-of-care market.
The total consideration for the transaction was C$9 million, comprising C$5.65 million in cash and C$3.35 million in Nanogen common shares.
"This acquisition provides Nanogen a solid position in the cardiovascular point-of-care market in advance of our congestive heart failure test receiving regulatory clearance.
"It was another opportunity to broaden our portfolio of rapid diagnostic tests, without research and development risk, and with opportunities to increase both the menu of producs and existing customer base," said Howard Birndorf, chairman and chief executive officer of Nanogen.
"We anticipate a smooth and rapid integration of Spectral's sales and manufacturing functions and a positive contribution to our near-term financial results and long-term market plans".
"With the addition of these cardiac tests, Nanogen has the necessary product line to compete in the cardiovascular point-of-care testing market," said David Ludvigson, president and chief operating officer.
"Our point-of-care group will continue to focus on FDA approval of a quantitative congestive heart failure diagnostic test and the development and launch of other complementary tests.
"We plan to leverage the existing customer network, the acquired manufacturing capability and the other products in our development pipeline to build market share".
Spectral reported nearly C$7 million in product revenues during 2005 from the Cardiac Status tests and i-Lynx readers.
The Cardiac Status line includes four FDA-cleared tests that can be used at the point-of-care to determine elevations of cardiac markers, providing an aid to physicians to assess and diagnose acute coronary syndrome (ACS) as indicated by chest pain.
The product line includes: Cardiac Status myoglobin, troponin I and CK/MB tandem 3 in 1 test to rule-in or rule-out ACS; Cardiac Status Troponin I, the single most critical marker to determine acute myocardial infarction (AMI); Cardiac Status myoglobin/troponin I to aid in the diagnosis of AMI.
The i-Lynx is a hand-held reader designed to capture and analyse the results of the Cardiac Status products as well as other rapid tests such as tests for cardiovascular disease, pregnancy and infectious diseases.
The portable electronic unit offers connectivity to customers' existing laboratory data management systems to help facilitate patient record keeping and billing functions.
The DecisionPoint product line is the same series of cardiac marker assays as the Status line designed for international markets, with CE marking.
The newly acquired rapid test business also includes the capability to offer private label brands to customers.
Several distributors offer the DecisionPoint products outside of the USA.
Cardinal Health distributes the Cardiac Status line and i-Lynx reader in the USA.
Approximately 50 of Spectral's employees, including those in manufacturing as well as a US and Canadian sales force, have joined Nanogen's point-of-care group in Toronto.