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SWOT Analysis for Molecular
Diagnostics: Strengths, Weaknesses,
Opportunities, and Threats
Daniel H. Farkas, PhD, HCLD
Director, Molecular Diagnostics, The Methodist Hospital
Associate Professor of Pathology, Baylor College of Medicine, Houston

David W. Bernard, MD, PhD
Medical Director, Clinical Chemistry, Department of Pathology, The Methodist Hospital
Assistant Professor of Pathology, Baylor College of Medicine, Houston



   “In other words, if an adenine forms one DNA and subsequently RNA as an              dominated molecular diagnostics in
member of a pair, on either chain, then on    analyte, not unlike glucose for dia-      the 1980s and into the early 1990s.
these assumptions the other member must       betes or antibodies for pathogens.        At that point, this labor-intensive,
be thymine; similarly for guanine and cyto-      The new nucleic acid-based diag-       time-consuming technique limited
sine…. If only specific pairs of bases can be nostic tool has developed many            molecular diagnostics to low volume
formed, it follows that if the sequence of    names, e.g., molecular diagnostics,       esoteric testing performed in regional
bases on one chain is given, then the se-     molecular pathology, molecular ge-        centers of excellence.
quence on the other chain is automatically netics, and molecular genetic pathol-
determined” — Watson and Crick, 1953.         ogy. Then, there are the inevitable       POLYMERASE CHAIN
   These famous words, from the subdivision names, such as molecular                    REACTION
classic letter to the editor of Nature,       hematology-oncology, molecular on-           The development in biotechnol-
described the newly dis-                                 cology, molecular virology,    ogy that revolutionized molecular di-
covered double helical                                   and molecular microbiol-       agnostics was the invention of poly-
structure of DNA. Watson                                 ogy. The list seems inex-      merase chain reaction (PCR) in the
and Crick continue, “It has                              haustible as we apply the      1980s. By the early 1990s, PCR be-
not escaped our notice that                              tools of molecular biology     came commonplace. Simply put, this
the specific pairing we have                             to every section of the hos-   in vitro nucleic acid amplification
postulated immediately                                   pital diagnostic pathology     technique is a highly specific way to
suggests a possible copying                              department (molecular co-      amplify targeted pieces of DNA (bac-
mechanism for the genetic Daniel H. Farkas,              agulation, molecular fro-      terial, viral, human) to obtain a much
material.” This quote may PhD, HCLD                      zen section) and to general    larger amount, so that DNA targets
be the most glaring understatement medicine (molecular cardiology).                     that were thought of as needles in a
in all biological literature.                    Although the fundamental discov-       haystack in the ’80s became haystacks
   Thus, over 50 years ago, was born eries of the double helical structure of           full of specific needles in the ’90s. One
the notion of nucleic acid hybridiza- DNA and the flow of genetic infor-                could use any number of straight-
tion, which is foundational for mole- mation from DNA to RNA to pro-                    forward detection techniques to com-
cular diagnostics. It is unlikely that        teins laid the foundation for clinical    plete the laboratory test.
Watson and Crick could foresee that molecular diagnostics, it came into                    PCR has gone through several iter-
their discovery of DNA’s structure being only with development of a key                 ations to reach its ubiquitous status in
would lead to the widespread diag-            technique called Southern blot hy-        2004. Today, PCR usually is per-
nostic use in the clinical laboratory of bridization analysis. This technique           formed by semiautomated instru-

46 BIOTECHNOLOGY HEALTHCARE · MAY 2004
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ments that couple amplification with        years ago the molecular diagnostics             (usually cancer) posttherapy
simultaneous fluorescence-based de-         marketplace accounted for less than 1        • Identify mutations associated
tection — a combination known as            percent of the total IVD marketplace.           with genetic disease (e.g.,
“real-time PCR.” Front-end robotics         While CT/NG and HIV testing be-                 leukemia, muscular dystrophy,
may automate the entire process             came established in the mid-’90s, CF            and Alzheimer’s disease) to
from specimen receipt to generation         testing has established itself only re-         name but three of many mole-
of laboratory test result, but only large   cently as a blockbuster test.                   cular genetic (including oncol-
specimen volumes tend to justify the           What is it about molecular diag-             ogy) targets
high costs of robotics. Real-time PCR,      nostics that has spurred such a dra-         • Sequence-specific genes in-
coupled with small, low-throughput          matic introduction into the world of            volved in hereditary cancers in
DNA/RNA purification instruments            clinical diagnostics? Is the growth             an effort to apply interventional
for low- to medium-volume tests             sustainable? This SWOT examina-                 therapy rationally before dis-
complement high-volume “home                tion, which analyzes the Strengths,             ease strikes (e.g., sequencing of
run” tests. Home run tests create an        Weaknesses, and Opportunities of,               BRCA-1 and BRCA-2 in breast
economic foundation for organiza-           and Threats to, molecular diagnos-              cancer patients and kindred)
tions that perform these tests, and         tics, may generate some answers.             There are scores of other applica-
they include the following:                                                           tions (for listings, go online to «www.
   • HIV load monitoring                    STRENGTHS OF MOLECULAR                    amptestdirectory.org» or to «www.
   • HIV and hepatitis C virus de-          DIAGNOSTICS                               genetests.org»).
      tection in blood units in the            Modern molecular pathology is             In the case of molecular virology,
      blood bank                            based on PCR (owned and marketed          “stat” molecular testing is now possi-
   • Chlamydia trachomatis and Neis-        by Roche and licensed to several other    ble through rapid (~20 minutes)
      seria gonorrhoeae (CT/NG) detec-      companies that also market tests) and     nucleic acid extraction from cere-
      tion, usually tested together         on PCR alternatives. The most popu-       brospinal fluid for detection of herpes
      from one specimen — the first         lar alternatives are:                     simplex virus infection in about an
      example of a molecular diag-             • Gen-Probe’s transcription-           hour. With positive identification,
      nostics “panel”                             mediated amplification              lifesaving antiviral therapy can be ra-
   • Cystic fibrosis (CF) mutation             • Becton Dickinson’s strand            tionally applied. Assessment of tu-
      detection, usually a 25-mem-                displacement amplification          mor gene “signatures,” also known as
      ber panel of mutations recom-            • BioMerieux’s nucleic acid            “gene rearrangement tests,” makes it
      mended by two professional                  sequence-based amplification        possible not only to diagnose specific
      societies; this is a grander ex-         • Branched DNA (bDNA) tech-            cancers, but also to monitor therapy
      ample of the potential for mol-             nology from Bayer and Chiron        and relapse. Advances in diagnostics
      ecular diagnostic panels.                These biochemical reactions per-       have been made in many sections of
   Estimates of the size of the world-      formed on purified nucleic acids from     the pathology department using the
wide in vitro diagnostics (IVD) mar-        patient specimens sensitively and         tools of molecular biology and ex-
ket range upward to $22 billion at the      specifically amplify DNA or RNA to        tending to applications in identity
manufacturer sales level, including         facilitate the answering of diagnostic    testing, transplantation, anatomic
instruments and reagents; the United        questions. Examples of these diag-        pathology (especially fluorescent in
States represents about half the total      nostic questions include:                 situ hybridization, or FISH), and even
market. It is reasonable to extrapo-           • Determine presence or absence        biowarfare agent detection.
late from the sales in the HIV viral              of pathogenic DNA (e.g., virus,        These examples of the strengths of
load marketplace, including screen-               bacterium, parasite, fungus)        molecular diagnostics demonstrate
ing of blood products, that the total          • Quantify viral load (e.g., HIV       that the diagnostic pathology labo-
value of molecular diagnostics is                 or cytomegalovirus) in in-          ratory has fully embraced nucleic acid
about 5 to 10 percent of the total IVD            fected patients to assess effi-     as an analyte. This type of testing has
market. The growth rate has been sig-             cacy of antiviral therapy           a market size equal or soon-to-be-
nificant, considering that only 10             • Detect minimal residual disease      equal to that of the protein tests for

                                                                        MAY 2004 · BIOTECHNOLOGY HEALTHCARE 47
CLINICAL FOCUS

immunodiagnostics, serology, and          of new tests. For example, in the past     ever, reaching new levels of service in-
other determinations. Clinical chem-      several years, new tests have been         crementally and slowly. Only after
istry analysis of conventional and tra-   added to the molecular pathology           years of research and trials does a new
ditional analytes such as glucose or      laboratory menu in hematology, co-         test or procedure become standard
sodium still dominates the market-        agulation, and iron overload disease.      care. This is true in every specialty.
place. Yet, the highly specific answers      Aside from CF mutation testing,            Much investigation remains in
provided by molecular diagnostics         however, no test recently has demon-       basic and translational research lab-
coupled with their potential to pro-      strated extremely high use. If HIV and     oratories to establish the genes and
vide physicians with valuable per-        CF are home run tests, then other          gene expression profiles that are im-
sonalized information on complex          tests, such as the FLT3 analysis for       portant in diagnosing and managing
diseases represent key strengths and      hematology, Factor VLeiden and pro-        complex diseases. Many trials must
growth potential.                         thrombin mutation detection for co-        be designed to determine whether
   In summary, pathology has en-          agulation workups, and hemochro-           test panels that are technically possi-
tered the genomic era. As molecular       matosis testing for iron overload          ble are useful clinically. Simply creat-
diagnostics continues to mature, it is    disease are no more than solid base        ing a panel of pathogens’ target nu-
in an excellent position to grow as       hits up the middle.                        cleic acids may not mean physicians
medicine moves into the post-                In the Northern United States in        will embrace it as pivotal for manag-
genomic era with the elucidation of       early spring, the first moderately         ing their patients. The time is coming
the role of more and more genes and       warm day tends to drive winter-            for molecular panels because pro-
gene products in complex diseases.        weary inhabitants to push the season       gress in that endeavor is inevitable,
While investigation of certain indi-      with spring-like garb, while winter        but in 2004 the era of molecular pan-
vidual genes in some cancers is diag-     clearly has every intention of return-     els has not fully arrived. Optimisti-
nostically advantageous, cancer and       ing. Are the biotechnology compa-          cally, this seeming weakness of mol-
many other diseases, including hy-        nies pushing the season of the post-       ecular diagnostics may be described
pertension, cardiovascular disease,       genomics era? So-called “one-off”          alternatively as an opportunity.
obesity, and diabetes, are multigenic     tests with a single analyte generally do      The reagents sold by IVD compa-
and complex. Molecular diagnostics        not portend huge financial returns in      nies are among the most expensive
is poised to take advantage of the ad-    molecular diagnostics; therefore,          used in the hospital-based pathology
ditional information coming from se-      most companies instead explore op-         department or reference laboratory.
quencing of the human genome. The         portunities for test panels that allow     Furthermore, some tests, while im-
rate of growth of these diagnostic ap-    analyses of many markers or patho-         portant to offer and perform, are or-
plications promises many more             gens simultaneously.                       dered so rarely that economies of
blockbuster applications for molecu-         The exception is the market leader,     scale are not realized by large batches
lar diagnostics in this decade alone.     Roche, which continues successfully        for test runs; this adds to the high ex-
                                          to add “one-off” tests to its dominant     pense of performing molecular diag-
WEAKNESSES OF                             real-time PCR platform. Some tests         nostic testing. The government-based
MOLECULAR DIAGNOSTICS                     have been brought to market prema-         reimbursement of molecular diag-
   In real estate, the mantra is “loca-   turely to generate sales in the diag-      nostics laboratories for performance
tion, location, location.” In molecular   nostic community, and in the process       of molecular tests is inconsistent.
diagnostics, the holy grail seems to      have attracted the negative attention         An example is viral load testing for
be “content, content, content.” The       of regulatory bodies. An example is        HIV, compared with testing for he-
marketplace is well served by the ven-    the Roche-Affymetrix cytochrome            patitis C virus (HCV). Many laborato-
dors that are supplying equipment         P450 chip, which the U.S. Food and         ries realize a profit margin of more
and reagents to molecular diagnos-        Drug Administration has suggested          than 100 percent on Medicare reim-
tics laboratories. Start-up and well-     requires more regulatory oversight.        bursement for HIV viral load testing.
established companies alike are con-         Modern medicine is based on re-         In contrast, profit margins are mini-
stantly trying to establish and           markable discoveries of biomedical re-     mal to nonexistent for the “same” test,
increase sales through introduction       search. Medicine is conservative, how-     done the same way, requiring the

48 BIOTECHNOLOGY HEALTHCARE · MAY 2004
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same labor, the same equipment and          of dilemma contributes to the high         relatively recently. Economic chal-
virtually the same reagents, but in-        cost of healthcare in this country and     lenges, including reimbursement and
stead targeting the genome for HCV.         represents a weakness within molec-        relatively high prices, will persist in
In fact, this test often is performed at    ular diagnostics testing. Reimburse-       molecular diagnostics for the fore-
a financial loss due to its lower reim-     ment issues, however, do not appear        seeable future.
bursement through Medicare. Non-            headed for rapid or easy resolution.
government third party payers may           Patent protection of genes and their       OPPORTUNITIES IN
reimburse at higher levels for this test.   applications further exacerbates cost      MOLECULAR DIAGNOSTICS
   Various industrial and professional      issues in molecular diagnostics. (This        Opportunities abound in the field
organizations have petitioned the           is discussed later within this article.)   of molecular diagnostics — for ex-
Center for Medicare and Medicaid               Poor reimbursement for some             ample, in pharmacogenomics, pan-
Services for appropriate Medicare re-       molecular diagnostics tests is com-        els, and arrays. Further, new tech-
imbursement for HCV viral load test-        pounded by the actions of some third       nologies may enable point-of-care
ing. This reimbursement situation is        party payers. In 2003, at least two        testing and new medically relevant
convoluted and complicated, with            payers announced that certain mole-        analytes that will emerge from the
many factors to consider. Besides           cular diagnostic tests would not be        completion of the sequencing of the
competing for use of limited re-            reimbursed. Both of these institutions     human genome.
sources at a time of multiple federal       remain in close dialogue with profes-         Pharmacogenomics may be the
governmental priorities, such as se-        sional organizations to help resolve       most immediate new opportunity in
curity, patient safety, and electronic      the difficult considerations around        molecular diagnostics. Response to
medical records, HCV viral load test-       reimbursement.                             therapeutic drugs by an individual is
ing is still relatively new.                   These declarations of nonpayment        partially a function of that individual’s
   Only recently have multiple stud-        seem to appear out of nowhere, un-         genetic make-up. Given that our
ies shown that therapy such as inter-       provoked and surprisingly quickly,         genomes define our individual char-
feron and ribavirin may be effective        demanding the immediate attention          acteristics to a greater or lesser extent,
for some patients with HCV and that         of the professional community to           depending on environmental factors,
monitoring of viral loads can aid in        provide data demonstrating the clin-       individualized drug metabolism is not
tailoring therapy and predicting re-        ical utility of the affected tests. Un-    surprising. The ability or inability to
sponse. In the interim, until this test-    derstandably, the payers’ point of         metabolize a drug is genetically de-
ing is viewed as medically necessary        view reflects their responsibility to      termined. Thus, a particular drug may
and not experimental, the laboratory        beneficiaries and shareholders. The        prove safe and effective in one indi-
medicine community is left with the         insurance industry may have con-           vidual, while the same drug causes a
unenviable task of educating the fed-       cerns about significant the cost of        severe adverse effect in another.
eral government to correct its reim-        widespread use of expensive tests that        Today, when we present to our
bursement schedules while laborato-         seem to be alternatives to cheaper in-     physicians with certain signs and
ries still perform the test.                cumbent diagnostic technologies,           symptoms, usually the physician pre-
   The resolution of HCV reimburse-         such as serology and culture, for the      scribes a particular drug that clinical
ment issues is critical, because he-        diagnosis of disease. Perhaps the          medicine has learned to be of value.
patitis C is the most common blood-         emergence of new technologies and          Sometimes drug therapy fails, possi-
borne infection in the United States,       assays for relevant analytes seems to      bly because of genetic variations in
with a death rate that is expected to       “appear out of nowhere” to the in-         metabolism of that drug. Genetically
triple over the next 15 years. Reim-        surance industry. To head off a flood      controlled drug metabolism may be
bursement aside, it may be suggested        of claims that would generate large        so slow in “slow metabolizers” that
that the price of the kits used in this     financial exposure, blanket denials of     the normal dose generates an exag-
important diagnostic assay is too           coverage are broadcast.                    gerated response due to build up of
high for the marketplace, at least for         Although molecular diagnostic           the drug in the body.
low-volume laboratories that cannot         technologies are almost 20 years old,         Conversely, diminution of effect
negotiate favorable prices. This kind       they have become mainstream only           may be expected for prodrugs that

                                                                         MAY 2004 · BIOTECHNOLOGY HEALTHCARE 49
CLINICAL FOCUS

are taken in an inactive form but re-       fice. The DNA automatically would           of the genome. In this sense, these are
quire conversion in the body to the         be extracted and then analyzed in an        not unlike computer chips that can
active metabolite. The day is not far       instrument that assesses the patient’s      perform thousands of calculations si-
off when laboratories will be able to       DNA for key genetic markers to in-          multaneously. The probes on the chip
test an individual for variations in par-   form the physician that, for example,       act like molecular Velcro that specifi-
ticular drug response genes. The test       drug A is a better choice for this pa-      cally binds related elements of the
results would help the physician pre-       tient than drug B because this patient      genome (while ignoring unrelated el-
scribe the right drug at the right dose     is incapable of metabolizing drug B         ements) for evaluation. Assuming
in a regimen specifically tailored to       into its active therapeutic form.           concerns about costs and quality con-
that individual, thereby maximizing            For the height of convenience,           trol are adequately addressed, chips
the chances of therapeutic success.         imagine a computer or telecommu-            likely will be used diagnostically. For
   Implicit in the word “pharmacoge-        nications link between the pharmacy         example, complex diseases like can-
nomics” is a synthesis of genomic in-       and the physician’s office that relays      cer may have gene expression signa-
vestigation and pharmaceuticals. Phar-      the information securely to the phar-       tures demonstrated by chip-based
macogenomics offers the potential for       macy so the results are available when      analysis that may be useful in differ-
reducing the average cost of developing     the patient arrives at the pharmacy.        ential diagnoses of diseases.
a new drug, now well over $1 billion        No time is spent waiting in the physi-
(Landers 2003). Many drug companies         cian’s office for the test results. These   THREATS TO MOLECULAR
are investing significantly in pharma-      are not farfetched scenarios, but real      DIAGNOSTICS
cogenomics in anticipation of shaving       opportunities for molecular diagnos-            The reimbursement challenges to
years off the drug discovery and ap-        tics as well as for companies offering      molecular diagnostics were intro-
proval process, bringing potentially lu-    innovative telecommunications or in-        duced in the section of this article de-
crative drugs to market much sooner.        formation technology solutions.             scribing weaknesses. Although these
   Applying pharmacogenomics also              Indeed, real-world examples of           reimbursement challenges pose eco-
has the potential for rescuing drugs        pharmacogenomics-based prescrib-            nomic threats to molecular diagnos-
that failed in early trials by ensuring     ing exist today. Trastuzumab (Her-          tic services, it seems clear that hard
that these drugs are prescribed only        ceptin) is a drug most efficacious in       work and open lines of communica-
to that portion of the population for       breast cancer patients who exhibit a        tion among all interested parties must
whom the drugs will be safe and effi-       particular genetic amplification of an      ultimately lead to appropriate reim-
cacious from a genetic viewpoint. The       oncogene, HER-2/neu. With a differ-         bursement for these medically im-
great opportunity for the molecular         ent kind of genetic anomaly, chronic        portant tests; if not, test availability
diagnostics field is that pharmaco-         myelogenous leukemia patients over-         will become limited.
genetic testing will need to be done        express a particular oncogenic protein          The patenting of many genes, mu-
before prescriptions are written. It is     that can be specifically blocked from       tations, and specific bacterial and
not a huge stretch of the imagination       performing its action by the drug           viral nucleic acid sequences repre-
to consider regulatory bodies that re-      known as imatinib mesylate (Gleevec).       sents an opportunity for commercial
quire a diagnostic test for pharmaco-          The genetics of drug response are        developers of molecular diagnostic
genetic signatures before a prescrip-       complex; so-called “DNA chips” al-          tests as well as a threat to practition-
tion may be written for a patient.          ready are being marketed that allow         ers of these same tests. Patents are a
   The best possible way to take full       the researcher and diagnostician to         key part of business in this country,
advantage of pharmacogenomics               study relevant genetic signatures in        and they stimulate research. Compa-
would be at the point of care, in the       patients. These will be important           nies must be allowed government-
physician’s office before the pre-          tools in defining practical and rou-        sanctioned protection of patents if
scription is written. Consider the day      tine diagnostic assays for drug choice.     they are to invest in what may be eco-
when a buccal swab (scraping of the            DNA chips are ordered arrays of          nomically risky endeavors. While this
inside of the cheek to harvest DNA-         specific DNA probes that allow si-          is true for the vast amounts of money
containing cells) or blood specimen         multaneous interrogation of hun-            necessary to bring a drug to market,
would be drawn in the physician’s of-       dreds to tens of thousands of portions      one must ask: is exactly the same in-

50 BIOTECHNOLOGY HEALTHCARE · MAY 2004
                                                                                                          CLINICAL FOCUS

tellectual property (IP) protection re-      pany must pay licensing fees and roy-      that the four attributes of molecular
quired for a test that may move from         alties to each of the ten companies        diagnostics presented — strengths,
research laboratory to clinical labo-        that own a piece of the IP landscape       weaknesses, opportunities, and
ratory in a year or two?                     used on that chip?                         threats — are interrelated. Gene
   Of course, companies seeking to              Finally, the burgeoning field of pro-   patents represent a return on invest-
enforce acquired patent rights are act-      teomics poses a potential threat to        ment opportunities for companies
ing in the best interests of their share-    molecular pathology, even as the lat-      while potentially threatening the abil-
holders. Such capitalistic imperatives       ter is still developing in the diagnos-    ities of a molecular pathology labo-
cannot be dismissed; our economic            tic arena. While assessment of DNA         ratory to perform the tests. Despite
system is essentially and fundamen-          sequences is relatively straightfor-       the diagnostic advantages of DNA
tally based in capitalism.                   ward technically, evaluation of RNA,       and RNA analytes, they are some-
   On the other hand, while courts           the next analyte in the progression of     times poorly reimbursed. The
and federal agencies have decided that       genetic information, requires gene ex-     Human Genome Project and oppor-
gene sequences are patentable, there         pression monitoring and is techni-         tunities such as pharmacogenomics
is growing concern that the enforce-         cally more difficult. It does, however,    offer promise for significant advances
ment of IP rights, with associated li-       provide a more direct picture of what      in diagnostic medicine — potentially
censure fees and royalties, may in-          occurs in complex disease states.          even personalized medicine. New
hibit the ability of pathologists to         Knowing the way genes are expressed        and emerging technologies continu-
supply molecular diagnostic testing          in healthy vs diseased tissue illumi-      ally improve speed and miniaturiza-
services (Cho 2003). Furthermore, the        nates rational therapy. By that logic,     tion, providing the potential for
added costs incurred by the labora-          analysis of the proteins involved in       point-of-care testing. One thing is cer-
tory are either passed through to the        disease provides the clearest snapshot     tain: basic and translational research
consumer or absorbed by the testing          of it by demonstrating the state of the    on the human genome and its gene
laboratory. If a laboratory needs to         proteome — the complete gamut of           products will continue, bringing con-
pay too many of these costs or if            proteins in action in the cell or tissue   siderable change to the fields of diag-
physicians do not order medically im-        at that time. Proteins carry out the       nostics and therapeutics in the
portant molecular diagnostic tests be-       business of life, so assessing the pro-    decades to come.
cause patients cannot afford them or         teome in diseased versus healthy tis-         For further information, see the Associ-
third party payers won’t provide re-         sue may give the most meaningful           ation for Molecular Pathology online at:
imbursement for them, then we risk           picture of the differences.                «www.ampweb.org».
limiting healthcare in this country.            Proteomics is a nascent science
   Clearly, de facto healthcare ration-      with fewer useful, well-developed          ACKNOWLEDGEMENT
ing already exists in the United States.     technical platforms than genomics or         Thanks to Karl Voelkerding, MD, of
Gene patents may exacerbate the sit-         gene expression analysis. Further-         ARUP Laboratories for supplying the
uation. Many companies are enter-            more, the temporal dimension of            original inspiration for this article.
ing the field of genomics in an effort       protein expression, which changes
to get a piece of the pie. There is a real   minute to minute in the cell, compli-      REFERENCES
threat that the genome will be so frag-      cates the application of proteomics        Cho MK, Illangasekare S, Weaver MA, et
                                                                                            al. Effects of patents and licenses on
mented by IP protection that tests will      to routine diagnostic laboratory med-          the provision of clinical genetic test-
become too expensive to perform              icine. How to control laboratory as-           ing services. J Mol Diagn. 2003;5:3–8.
                                                                                        Landers P. Cost of developing a new drug
and reimburse. Unchecked prolifera-          says for RNA and protein half-lives,
                                                                                            increases to about $1.7 billion. Wall
tion of IP on the genome could con-          which can differ dramatically, is a            Street Journal. 2003 Dec. 8:B4.
sume the golden goose. This is even          technical challenge that needs to be       Watson JD, Crick FHC. Molecular struc-
                                                                                            ture of nucleic acids. A study for de-
more apparent in the opportunity             addressed for both gene expression             oxyribose nucleic acid. Nature (Letter
that DNA chip-based panels present.          analysis and proteomics.                       to the Editor). 1953;171:737–738.
How could a company possibly place                                                          Available at: «http://www.nature.
                                                                                            com/genomics/human/
an affordable price on a diagnosti-          CONCLUSION                                     watson-crick/». Accessed April 13,
cally important chip if the chip com-         This SWOT analysis demonstrates               2004.


                                                                          MAY 2004 · BIOTECHNOLOGY HEALTHCARE 51

				
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