In this article:
- Four factors that drive MDx industry growth
- Plan ahead to expand test menu, space and staff
- This is a great time to start a molecular diagnostics lab
By Frederick L. Kiechle, MD, PhD
The current molecular diagnostics market is growing rapidly. It is dominated by infective agents, oncology, pharmacogenomics, and genetic diseases.4 In 2009, molecular diagnostics was growing at 29 percent.1-3 In 2008, Global Industry Analysts, Inc., predicted a global market for molecular diagnostics at $3.67 billon in 2010,2 compared to $4 billion by Deloitte Consulting, LLP for 2010.1 Global Industry Analysts predicted global market size at $6.35 billon 2 or $5.8 billon 3 by the year 2015.
There are four factors that will drive the continued growth of molecular diagnostics.
1. A Reimbursement Resolution
Future expansion and growth of the molecular diagnostics market will require a resolution of reimbursement issues and adequate descriptive Current Procedural Terminology (CPT) codes. Without sufficient reimbursement, physicians generally will not adopt a diagnostic test regardless of whether or not a payer’s choice to cover the diagnostic at a specific level of reimbursement that varies by third party payers.
2. Clear FDA Guidance
The second driver for growth is the need for clear guidance from the Food and Drug Administration (FDA) as to what constitutes Analyte Specific Reagents (ASR), Research Use Only (RUO) and Laboratory Developed Tests (LDT), as well as the future direction in these definitions.5
The third growth factor requires increased interaction between pharmaceutical companies and molecular diagnostics manufacturers to continue to develop companion diagnostic assays, which will aid in determining whether a given patient qualifies for a particular drug (pharmacogenomics).
4. Point-of-Care Testing
The fourth major driver for growth in the molecular diagnostics industry is the miniaturization of the three basic molecular assay steps, using biochips, microfluidics, and nanobiotechnology.5 These developmental improvements will lead to the availability of molecular diagnostics devices that can be used for near-patient or point-of-care testing, which will provide a clinically useful result in minutes to several hours instead of half a day or 24 hours.
Molecular is Catching On
So what does all this mean? The improvement in workflow and turnaround time for most molecular diagnostics assays has lead to an increase in the number of clinical laboratories offering these types of tests.1 The test menu will be driven by the needs of your practicing clinicians.
It is imperative to plan your test menu and rate of growth with laboratory and hospital administration, as well as clinicians, to assure access to adequate space, adequate staff, and adequate budget for reagents and equipment. The clinician needs the results to many of these molecular based assays within the same day.
In general, the approach of sending them all out to a reference laboratory could lead to an annual 15 percent increase in the overall lab budget. The clinicians may complain about the two- to four-day turnaround time. Rapid results are required in order to provide adequate patient care, including VZV infections in pediatrics, MRSA screening prior to a surgical procedure, and CMV quantification in transplant patients.
Identifying an infectious agent after four days may be of no clinical value. If there is this clinical need to improve molecular-based assay turnaround time and a molecular diagnostics lab is not set up in house, there is only one other alternative: Find a molecular lab in close geographical proximity and arrange for that lab to do turnaround time-sensitive, molecular-based diagnostics.
The growth factors listed above will stimulate the molecular-based equipment and reagent manufacturer to continue to simplify the commercial assays for easier validation and adoption in the clinical laboratory. This point in time is excellent for the initiation of a successful molecular diagnostics lab.8-9
- Goverman IL, Jacoby R, Lester RG. Bench to bedside. Formulating winning strategies in molecular diagnostics. Deloitte Consulting LLP. 2009.
2. Global marketing diagnostics to reach 3.67 billion dollars by 2010, according to report by Global Industry Analysts, Inc. 2008.
3. Global molecular diagnostics market to reach US $5.8 billon by 2015, according to a report by Global Industry Analysts, Inc. 2010.
4. Chen B, Gagnon M, Shahangian S, Anderson NL, Howerton DA, Bonne DJ. Good laboratory practices for molecular testing for heritable diseases and conditions. MMWR 2009; 55 (RR 06):1-29.
5. Food and Drug Administration. Draft guidance for industry and Food and Drug Administration staff. Commercially distributed in vitro diagnostic products labeled for research use only: Frequently asked questions.
6. Holland CA, Kiechle FL. Point of care molecular diagnostic systems – past, present and future. Curr Opin Microbiol 2005; 8(5): 504-509.
7. Kiechle FL, Holland CA. Point-of-care testing and molecular diagnostics. Miniaturization required. Clin Lab Med 2009; 29: 373-582.
8. McLeod PS. Molecular diagnostics: How Beaumont built a successful program. The Dark Report 2005; 12(11): 9-17.
9. McLeod PS. Experience teaches valuable lessons at Beaumont. Picking winners and losers for the molecular test menu. The Dark Report 2005; 12(12): 9-14.