APC Western Region Direct to Consumer Testing DTC

APC Western Region Direct to Consumer Testing (DTC): The Good, the Bad, and the Ugly Edward Ashwood, MD

Disclosures o Former CEO of ARUP Laboratories – which offered no DTC testing o Currently Director of Laboratories, CU Hospital – which offers DTC testing o Outspoken critic of Theranos for several years – which offered DTC testing until October 5, 2016!

Objectives 1. Describe Direct to Consumer Testing (DTC) 2. Compare the differences in DTC quality 3. Recognize fraud and act to report it

Three DTC Examples o University of Colorado Hospital Clinical Lab – Testing offered to consumers 2001 to present o Global Cancer Diagnostics (GCDx) – Testing offered to consumers 2014 to 2015 o Theranos – Testing offered to consumers 2013 to 2016

University of Colorado Health FY 2015 Fact Sheet • $3 B in revenue • 7 hospitals (1 new site under construction) with 1, 528 hospital beds • 17 freestanding EDs • 15, 388 employees • 104, 072 admissions and observation visits • 11, 571 babies delivered • 60, 680 surgeries • 348, 705 emergency room visits • 2, 338, 759 outpatient visits Poudre Valley Hospital Fort Collins Medical Center of the Rockies Loveland Longs Peak Hospital Longmont (2 Q 2017) Broomfield Hospital Denver Metro (Sep 2016) University of Colorado Hospital Denver Metro Memorial Hospital North Colorado Springs Grandview Hospital Colorado Springs (Oct 2016) Memorial Hospital Colorado Springs 6

DTC Process, CU o o o o Advertising is word-of-mouth – No mention of DTC on Denver Metro web site Consumers ask for testing at the laboratory Given Test Brochure and Requisition Payment information collected Lab staff collect blood at nearby phlebotomy station Testing performed in CAP accredited CU hospital lab Test results mailed to consumer

Test Requisition, CU o o o Name, address, DOB, gender, fasting, phone number Optional: provider, address Consent Test menu: 20 tests, with costs Payment by cash, MC, Visa

Test Volumes at CU DTC, TTM Test Price #/yr Chem 30 (CMP, lipid, TSH) $60 371 CBC with Autodiff $21 84 Hemoglobin A 1 C $25 72 25 Hydroxy Vitamin D $40 36 PSA Total $30 30 hs. CRP $25 23

DTC Results, CU o o All results reviewed by resident and Clinical Pathologist Example: 46 yo female – Chem 30 significant findings: – Ferritin = 5 ng/m. L (11 -307 ng/m. L) – TSH = 0. 02 m. IU/L (0. 34 -5. 60 m. IU/L) – CBC: – Hct = 39% (35. 7 to 46. 7%) – MCV = 68 f. L (80 -100 f. L) – RDW = 42 f. L (37 -49 f. L) o Action taken?

DTC Process, GCDx o o o Former web site advertised test Consumers print test requisition from web site In 26 states, consumer goes to a phlebotomy center – Test menu: 1 test, “The Lung Cancer Test”™ – Pays $99 plus S/H by credit card Phlebotomy center ships specimen to GCDx Implied US Preventive Services Task Force endorsement: – “recommends annual screening for lung cancer” adults 55 -80 with 30 -pack year smoking history Source: GCDx web site

Test Claims o o “Clinical validation study completed with excellent results (97% AUC for ROC)” Performs ‘better than low-dose CT’ www. youtube. com/watch? v=5 u. Hdc. Id. V 90 M

Test Claims o o o Consists of ‘multiple immune tests’ and ‘proprietary mathematical analysis’ FDA submission planned, yet LDT offered DTC ‘Confidential’ results are not shared with insurance companies No publications in pubmed What action can you take? GCDx web site and www. youtube. com/watch? v=5 u. Hdc. Id. V 90 M

Theranos o o o Founded 2003, phenomenal fund raising ($700 M) Partnership with Walmart, September 2013 Prices charged to consumer: half of CLFS Advertising: web site, TED talk, national magazines Analytic Methods: secret (‘stealth mode’) Claims and statements – “hundreds of tests from a drop of blood”

Theranos o Nanotainer o Microfluidic device, AKA Edison

Only Published Study

CRP o o While correlation looks impressive, Graph is log-log

CRP – properly graphed o Poor correlation at both low and high concentrations

Theranos – Timeline o o o 2003 founded Real-Time Cures 2004 rebranded as Theranos 2004 to 2015: phenomenal fund raising from private investors 2013 May: Ian Gibbons suicide 2013 Sep: Walmart partnership started, DTC commences

Theranos – funding Funding Date Deal Size Valuation Series A 2005 Mar $7 M $27 M Series B 2006 Feb $9 M $46 M Series C 2006 Nov $32 M $159 M Series C 1 2010 Jul $45 M $1, 120 M Series C 1, cont 2013 Mar $84 M $1, 270 M Series C 2 2015 Mar $573 M $9 B http: //pitchbook. com/news/articles/ theranos-ban-a-reminder-that-unicorns-arent-bulletproof

Test Menu o Too many choices for consumers

Theranos – test methods o o Edison tests, a few dozen? Traditional testing, diluting nanotainer specimens to achieve adequate volume? – Siemens Advia – Siemens BCS XP – “Nanotainer is uncleared medical device” Sendouts, hundreds From CMS inspection report “approximately 890, 000 patient tests annually”

Selected Sendout Volumes Test #/yr Hemoglobin A 1 C 15, 625 Reverse T 3 6, 812 t. TG Ig. A and Ig. G 2, 686 Gliadin Peptide Ig. A and Ig. G 2, 516 Estrone 2, 965 25 Hydroxy Vitamin D 1, 112 Source: confidential

Theranos – Timeline, cont o o 2015 Jul: FDA clears qualitative HSV-1 antibody test 2015 Aug: FDA inspection – “Nanotainer is uncleared medical device” 2015 Oct: John Carreyrou WSJ article 2015 Nov: CMS inspection

Theranos – Naïveté o o o “We are providing actionable information that can influence societal development; a system where everyone has access to information before a disease progresses” Lobbying: “Theranos advocacy for FDA regulation of LDT's and related matters. ” “We’ll put this out there and let people judge for themselves what the facts are, ” -- (NYT 2015 Oct)

CLIA Regulation

Theranos – Timeline, cont o o 2016 Jul: AACC hosts Theranos in front of 3000 annual meeting attendees – Pivot to minilab 2016 Aug: FDA inspection re Zika test 2016 Oct: Theranos stops DTC testing, fires 340 staff Many lawsuits pending

Theranos – Lessons o o o Consumers don’t understand laboratory tests well enough to choose wisely from hundreds of tests. Mixing stealth technology with healthcare yields snake oil AACC erred in giving Theranos a special session at their 2016 summer meeting – But the pivot to minilab exposed insincerity Don’t confuse products and services Don’t be frightened by outlandish claims

University of Colorado Anschutz