Santa Monica, CA – The healthcare testing landscape is constantly evolving to provide quality care and meet the changing needs of patients and other relevant stakeholders. Over the years, advances in technology, innovation and the increasing popularity of personalized medicine have allowed for more sophisticated resources to help clinicians make decisions.The level of sophistication of diagnostics and the value they can provide has evolved from a traditional Dx with a single input and output to clinical decision support tools that can analyze multiple inputs and provide actionable recommendations for clinicians (Figure 1).Figure 1. Significance and Evolution of Clinical Diagnostics

Traditional Dx tests are basic tests that take a single analyte as an input and provide an answer to a simple question with an absolute answer as an output (e.g., flu test, HbA1c level, pathogen presence/absence). The next generation of diagnostics, multi-analyte assays with algorithmic analysis (MAAA), goes beyond characterizing a patient's current state to ask more predictive questions (e.g., predict risk of tumor recurrence (e.g., Genomic Health – Oncotype Dx), likelihood of heart transplant rejection (e.g., CareDx – AlloMap) by analyzing multiple analytes from a single input with the help of an algorithm. Now, a new generation of novel diagnostics have emerged that surpass previous efforts by pulling disparate inputs like patient data, available treatments and ongoing clinical trials to provide a more comprehensive output with recommendations for overall patient management (e.g., identify the best course of treatment for a patient (e.g., Foundation Medicine – FoundationOne, VisualDx – Dermatology).Clinical Diagnostics Market OverviewThe IVD market, which represents a global opportunity of ~$60B, is led by traditional diagnostics companies including Roche, Abbot and Danaher (Figure 2). Most applications utilize traditional technologies (e.g., immunoassay and clinical chemistry) primarily for infectious disease, diabetes and general chemistry applications.Figure 2. In-vitro Diagnostics Market Landscape

However, a high-level review of various financial metrics shows that companies developing MAAAs and clinical decision support tools outperform traditional diagnostics companies (Figure 3). Companies that develop MAAAs and clinical decision support tools tend to have lower overall revenues than traditional diagnostic companies, but their annual growth rate and gross profit margin is higher. Though MAAA and clinical decision support companies are newer which may contribute to a higher growth rate, they also have higher market cap valuations relative to their revenue of 3.5 – 4X compared to ~2X multiple among traditional diagnostic companies.Figure 3. Overview of Select Financial Metrics by Clinical Diagnostic Group

Market TrendsChanging market trends have allowed for the development of MAAAs and clinical decision support tools (Figure 4).First, the amount of available information to support clinical decisions has grown significantly. Over the last decade, the number of publications and ongoing clinical trials have increased at a rate of ~85% and ~55%, respectively, reaching into the millions.Second, a better understanding of diseases and the number of available drugs have made treatment decisions more complex over the last few decades. For example, a growing knowledge base of the genetic mutations in non-small lung cell cancer has been able to identify more precise patient groups based on genotypic information (e.g., KRAS, EGFR mutations).Finally, advances in technology and IT have made an increasing amount of data accessible and elevated the types of analyses that can occur (e.g., cost of sequencing the human genome has decreased by). Similar to Moore's law where computer power doubles every two years due to technological improvements, the cost of sequencing a human genome has dropped in cost from >$10M in 2006 to ~$1,000 per human genome in 2016 driven by advances sequencing technology.The significant growth in available information, disease understanding and treatment options has placed considerable pressure on clinicians increasing the potential for diagnostic errors. While guidelines continue to incorporate new information, clinicians must balance this additional information within the limits of a working day. For example, it is estimated that clinicians would have to spend more than 21 hours per day to meet recommended practice guidelines.Figure 4. Clinical Diagnostics Market Trends

Commercial ImplicationsEach type of diagnostic comes with its own benefits and drawbacks that have commercial implications (Figure 5). While traditional diagnostics tend to have a clearer regulatory and reimbursement pathway and incur lower product development costs, [Group C] tests tend have a stronger value proposition and can command a much higher price point. Furthermore, regulatory and reimbursement challenges are expected to improve with time as more tests become available on the market (e.g., Foundation Medicine is currently working on simultaneous FDA approval and CMS review).Figure 5. Benefits and Drawbacks by Clinical Diagnostic Group

Recent Market ActivityWhile many of the traditional diagnostics were developed by older, leading diagnostic companies, many of the novel technologies in recent years have come from nontraditional diagnostic companies like newer companies (e.g., Foundation Medicine) or IT companies (e.g., IBM Watson Health).IT companies have continued to expand into the healthcare space with the number of partnerships growing. IBM Watson in particular has created partnerships with broad healthcare organizations including Medtronic, CVS and Anthem (Figure 6).Figure 6. Summary of Select Partnerships / Acquisitions by IBM Watson Health

To stay competitive in a changing market, many older Dx players have started developing partnerships or acquiring novel diagnostics companies (e.g., Roche buys a majority stake in Foundation Medicine) (Figure 7).Figure 7. Select Partnerships / Acquisitions

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Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-B0FF0494F1AD478CF9BE67E11ACA84CE" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-4AD0B191512DD53C4CE44381904023F3" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-96F00F3D1EF7A022E46CFBDDDCB37DE0" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-708FCCD5E4AC5007C409F028258C0C5D" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-82446A3B15DE1EDEFCF8C683AA4EA41F" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-DE7ED3C82D87B1B9B04657310892B310" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-2357836A65A766F65FE8E0E0C4FB3786" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-86D9C72A1819E92F2FEC597D9B906963" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-092D384AADD2ED67A5918768757EFEB8" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-B43E5608D8C397951C05933D0D30EC07" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-5A611C58BC092CBCEF905133866C6B9D" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-F36DCA81E47747003E6BBA06F28FB7DB" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-6C8309A12EBABEA0DA257D1E3956A399" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-37348F29C8F0D0206340B67C335722A1" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>#47<pwa data-pwa-id="pwa-9EFB2BCB1EE74A7F901F37B5574F257C" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>&amp<pwa data-pwa-id="pwa-CFD5BB85BA9124F1D277494D25EDD36E" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-A8BC3D3298613010AFC550CE8D181BF4" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-8885E20497DC91C0FD396E72463E0161" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-305C2613290E731E95F21CC581A5A3B3" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-126CB6EE8D430346D94DDCA23F09BFA1" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-9CC2A93247C153A77CEEB8C770B7B0B5" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" data-pwa-hint="The punctuation mark ';' may require a space after it. Consider adding the space." data-pwa-suggestions="; " data-pwa-heavy="false" data-pwa-dictionary-word=";" class="pwa-mark pwa-mark-done">;</pwa>amp<pwa data-pwa-id="pwa-5AAF4FD549960BEB31634BCCC8D95407" data-pwa-rule-id="WHITESPACE" data-pwa-category="grammar" d