Crescendo Reached on Long-standing Quest for FDA Regulation of Laboratory-developed Tests

The FDA made official in 2010 its intent to revise its previous LDT policy (in which there effectively was none), citing insufficient evidence in claims of an LDT’s efficacy, a lack of controls, yielding false results, or developers fudging numbers and producing fake results. While there has been a fair amount of FDA statements since 2010, In the absence of action, we see a thriving market.


With Final Rule, PAMA Set to Spark Changes in Lab Market and IVD Strategy

With Final Rule, PAMA Set to Spark Changes in Lab Market and IVD Strategy

This blog post reviews regulatory developments in the United States relevant to the clinical lab services and U.S. in vitro diagnostics (IVD) markets. For more information regarding recent market developments or trends in either market, Kalorama Information offers the market research reports United States Market for In Vitro Diagnostic Tests and Clinical Laboratory Services Market.

In late June of this year, the Centers for Medicare and Medicaid Services (CMS) announced the final rule of the 2...


Direct-to-Consumer Services Put Down Roots in U.S. Lab Testing Market

Direct-to-Consumer Services Put Down Roots in U.S. Lab Testing Market

Still framed as an open proposition in healthcare, the direct-to-consumer (DTC) lab testing market has already captured robust demand from U.S. consumers. Sales of DTC testing services have rapidly grown outside the traditional paradigm of physician-facilitated clinical testing. Kalorama Information’s Direct-to-Consumer Laboratory Testing Market has served as an important reference in recent articles by the New York Times, Forbes, and Becker’s Hospital Review. Whereas media coverage has focused ...


Take Stock of the LDT Market Landscape with the New Kalorama Information White Paper

Take Stock of the LDT Market Landscape with the New Kalorama Information White Paper

Kalorama Information offers comprehensive analysis of the cancer diagnostics market, including cancer testing services, with The World Market for Cancer Diagnostics, 6 th Edition. The free white paper regarding laboratory-developed oncology tests is available here.

The test service model has become a leading strategy for laboratories and even some IVD companies looking to expand their footprint in the cancer diagnostics market. In the leading U.S. market, company-owned test services have long ...


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...


Theranos Aims Big Outside of LDTs’ Esoteric Pigeonhole

Theranos Aims Big Outside of LDTs’ Esoteric Pigeonhole

More information regarding the clinical lab testing or clinical lab services market can be found in Kalorama Information’s Clinical Lab Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles). Kalorama also offers specialty market coverage of retail clinics with Retail Clinics 2015: Growth of Stores, Consumer Opinion, Leading Competitors, Sales of Products to Clinics (Diagnostic Tests, Pharmaceuticals, Vaccines), Clinic Sales Forecasts and Trends.

Carefully watched...


Ariosa Matches Sequenom-Illumina with NIPT LDT Licensing Move

Following the agreement between Sequenom and Illumina earlier this year allowing the latter to license pooled non-invasive prenatal testing (NIPT) IP to third-party labs worldwide, Roche Diagnostics’ Ariosa Diagnostics announced this week that it would grant licenses to labs for its own technology relating to NIPT. The three major players in prenatal testing operate their own labs to perform NIPT services on sent-out samples, but have encouraged outside labs to adopt their technologies in order ...


Carrier, Prenatal and Pediatric Genetic Testing Still a Big Draw for Investors and Labs

Carrier, Prenatal and Pediatric Genetic Testing Still a Big Draw for Investors and Labs

Genetic testing for inherited diseases has been a volatile industry space in recent years headlined by Myriad Genetics’ hold over BRCA testing and the subsequent opening of that market to competition with a 2013 Supreme Court ruling. Outside of testing for patient testing for oncology risk, a significant component of genetic testing is reproductive health-oriented testing for carrier genes and prenatal conditions. Atop the high-growth market for non-invasive prenatal testing (NIPT) are Sequenom ...


Eurofins Acquisitions Highlight Leading Growth Areas in Clinical Laboratory Services Market

Eurofins Acquisitions Highlight Leading Growth Areas in Clinical Laboratory Services Market

Eurofins Scientific, a leading global provider of “bioanalytical” laboratory testing services with projected 2014 revenue of approximately $1.7 billion , recently broadened its business activities into the clinical space with two acquisitions. The laboratory group’s traditional business activities are overwhelmingly within food and feed testing (~40% of revenue); pharmaceutical and biotechnology industry testing (40%); and environmental testing (20%). Eurofins already serves as a contract resear...