The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition

New Report Says In Vitro Diagnostic Market Reaches 54.6Billion 

NEW YORK, N.Y. - The world marketfor diagnostics is estimated at $54.6 billion in 2013, according to KaloramaInformation.  The market is expected to grow 4% annually and reach $65billion by 2018.  This includes all laboratory and hospital-basedproducts, and OTC product sales.  Kalorama revealed the market estimatesin its biennial survey of the IVD industry, The Worldwide Market for In Vitro DiagnosticTests, 9^th Edition. 

 New technology is leading thecharge, according to Kalorama.  Diagnostic laboratory technology haschanged dramatically in the past few years, due to the publication of the humangenome project and advances in functional genomics, bioinformatics,miniaturization and microelectronics. 

“Not three years ago it would havebeen almost inconceivable to see research technologies such as genomesequencing and mass spectroscopy play a pivotal role in improving labmedicine,” said Shara Rosen, Kalorama’s lead diagnostic analyst and the authorof the report.  “Their influence is felt in personalized medicine,inherited diseases, pathogen detection, antibiotic resistance testing, bloodbanking and much more to come.”

 According to the report, thisphenomenon has seen the major vendors of these technologies enter the IVDmarket.  Life Technologies, Illumina, Affymetrix, Bruker Daltonics,PerkinElmer/Caliper and others have all launched clinical tests and testservices.

Commentary on LDT Regulatory changes

The 8th edition of this report published in 2012 discussed the possible regulation of lab developed tests (LDTs).  Well in 2014, the possible is a reality.  In the beginning …. September 2006, the FDA issued a draft guidance on analyte specific reagents (ASRs), which are commercially available reagents used in lab developed tests (LDTs).  The FDA decided to use enforcement discretion and excluded laboratory-developed tests from the ASR rule based on confidence in a high-complexity laboratory’s ability to use them.

LDTs are developed within the laboratory and do not currently require FDA clearance. They are currently regulated under CLIA as highly complex tests and thus are subject to in-house validation and cGMP quality documentation requirements.

August 1, 2014, the FDA announced plans to implement a risk-based regulation of laboratory-developed tests over the course of nine years.  The FDA also said it plans to release its draft guidance in 60 days.  The FDA’s announcement comes out at a time when the agency has come under increasing pressure from congressional and federal advisory committees, consumer groups and the industry to expand its oversight of in-house developed testing.  The FDA announcement stated that LDTs have become an intrinsic part of personalized medicine and that inaccurate test results could cause patients to seek unnecessary treatment, or delay and sometimes forgo treatment altogether.  Further the policy change “demonstrates the agency's commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

The statement also stated that the FDA would implement the regulations over a nine-year period and would focus on tests where a wrong result would pose the highest risk for patients.  It also said it would exempt tests for which there is no approved alternative and tests for rare diseases.

The FDA says it intends to require pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market.  The draft guidance also proposed that LDTs would be classified as Class I, II, or III depending on risk.  The agency will first focus on high-risk devices that have the same intended use as cleared or approved companion diagnostics. 

It is expected that the classification may take the form of a proposal submitted by the American College of Medical Genetics and Genomics.  In 3013, the American College of Medical Genetics and Genomics (ACMG, www.acmg.net/) released a framework to standardize risk classification of laboratory developed tests (LDTs) for inherited conditions. The approach represents a regulatory context that the group hopes will be used to assist federal agencies and policymakers.  The ACMG presented risk-based classification that aligns risk with the medical decisions made based on the test results and how an incorrect result or interpretation might impact patients.