Top Infectious Diseases in the IVD Market - HIV

The following analysis is derived from Kalorama Information’s recently released global market research report: The Worldwide Market for Infectious Disease Diagnostic Tests.

This is the second in a series of five posts outlining the leading infectious diseases or disease groups in terms of IVD market sales.

At over $2 billion in IVD market revenue, diagnostic tests for human immunodeficiency virus (HIV) infections are found across segments, including immunoassays, molecular assays, and blood ...


POC IVD a Viable Business Model for Theranos

POC IVD a Viable Business Model for Theranos

Intrigue regarding stealthy diagnostics and lab testing company Theranos has given way to controversy as recent reports and allegations question the efficacy of the company’s core technology. Theranos recently disclosed that the fingerstick sampling method used in conjunction with its in-house developed IVD analyzer, referred to as ‘Edison’ in reports, is now limited to only one test, a FDA-approved laboratory developed test (LDT) for herpes simplex virus-1 (HSV-1). The reduced role of Theranos’...


Theranos Responds to Skeptics, Industry as Platform Remains Under Wraps (Update)

Theranos Responds to Skeptics, Industry as Platform Remains Under Wraps (Update)

Palo Alto, CA-based Theranos continues to make waves in the IVD industry. The most recent event is the release of a critical Wall Street Journal report including interviews with former employees. The Silicon Valley company has released a statement in response to claims in the report. Kalorama Information’s profile of the potentially disruptive clinical testing service company can be read here.

The extent of the Theranos platform’s capabilities remains uncertain; a former employee claimed in th...


Top Infectious Diseases in the IVD Market - Respiratory Tract Infections

Top Infectious Diseases in the IVD Market - Respiratory Tract Infections

The following analysis is derived from Kalorama Information’s recently released global market research report: The Worldwide Market for Infectious Disease Diagnostic Tests.

This is the first in a series of five posts outlining the leading infectious diseases or disease groups in terms of IVD market sales - beginning with tests for respiratory tract infections.

At well over $1 billion in IVD market space, tests for respiratory tract infections are supported by all three of the major diagnosti...


Beyond OncoType: Test Service Approach Prospers

Beyond OncoType: Test Service Approach Prospers

In the traditional in vitro diagnostics (IVD) market, diagnostic companies (manufacturers) develop, manufacture, and market diagnostic tests that are sold to and used by clinical laboratories. In the U.S., these tests are regulated by the FDA. This is the model that is being followed by a large segment of the cancer diagnostics market today. However, for cancer diagnostics, there have been exceptions to this model all along. For example, histology laboratories purchase stains, and often purchase...