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A12   HEALTH
                 Tuesday 1 december 2020

            First blood test to help diagnose Alzheimer’s goes on sale


                                                                                                                                rate either.”
                                                                                                                                ACCURACY CLAIMS
                                                                                                                                The company has not pub-
                                                                                                                                lished any data on the test’s
                                                                                                                                accuracy,  although  the
                                                                                                                                doctors have published on
                                                                                                                                the amyloid research lead-
                                                                                                                                ing  to  the  test.  Company
                                                                                                                                promotional  materials  cite
                                                                                                                                results  comparing  the  test
                                                                                                                                to  PET  brain  scans  —  the
                                                                                                                                current  gold  standard  —
                                                                                                                                in  686  people,  ages  60-91,
                                                                                                                                with  cognitive  impairment
                                                                                                                                or dementia.
                                                                                                                                If a PET scan showed amy-
                                                                                                                                loid buildup, the blood test
                                                                                                                                also gave a high probability
                                                                                                                                of that in 92% of cases and
                                                                                                                                missed 8% of them, said the
                                                                                                                                company’s  chief  execu-
                                                                                                                                tive, Dr. Joel Braunstein.
                                                                                                                                If  the  PET  scan  was  nega-
                                                                                                                                tive,  the  blood  test  ruled
                                                                                                                                out amyloid buildup 77% of
                                                                                                                                the time. The other 23% got
                                                                                                                                a  positive  result,  but  that
                                                                                                                                doesn’t  necessarily  mean
                                                                                                                                the  blood  test  was  incor-
                                                                                                                                rect,  Braunstein  said.  The
                                                                                                                                published  research  sug-
                                                                                                                                gests  it  may  detect  amy-
                                                                                                                                loid buildup before it’s evi-
                                                                                                                                dent on scans.
                                                                                                                                Braunstein  said  the  com-
            This Wednesday, July 22, 2020, photo provided by C2N Diagnostics shows equipment in a lab that analyzes blood samples at the   pany  will  seek  FDA  ap-
            company’s facility in the Center for Emerging Technologies in St. Louis.
                                                                                                               Associated Press  proval and the agency has
                                                                                                                                given it a designation that
            By MARILYNN MARCHIONE        agree  that  a  simple  test  sure  the  protein  is  a  costly  and results come within 10  can speed review. He said
            AP Chief Medical Writer      that can be done in a doc-   PET brain scan that usually is  days.  It’s  sold  in  all  but  a  study results would be pub-
            A  company  has  started  tor’s  office  has  long  been  not covered by insurance.  few  states  in  the  U.S.  and  lished,  and  he  defended
            selling the first blood test to  needed.                  That  means  most  people  just was cleared for sale in  the decision to start selling
            help  diagnose  Alzheimer’s  It might have spared Tam-    don’t get one and are left  Europe.                       the test now.
            disease, a leap for the field  my  Maida  a  decade  of  wondering if their problems  It  measures  two  types  of    “Should  we  be  holding
            that  could  make  it  much  futile  trips  to  doctors  who  are  due  to  normal  aging,  amyloid particles plus vari-  that   technology   back
            easier  for  people  to  learn  chalked  up  her  symptoms  Alzheimer’s  or  something  ous forms of a protein that  when  it  could  have  a  big
            whether they have demen-     to   depression,    anxiety  else.                        reveal  whether  someone  impact  on  patient  care?”
            tia.  It  also  raises  concern  or  menopause  before  a  The blood test from C2N Di-  has  a  gene  that  raises  risk  he asked.
            about  the  accuracy  and  $5,000 brain scan last year  agnostics  of  St.  Louis  aims  for  the  disease.  These  fac-  WHAT OTHERS SAY
            impact of such life-altering  finally  showed  she  had  Al-  to  fill  that  gap.  The  com-  tors  are  combined  in  a  Dr.  Eliezer  Masliah,  neuro-
            news.                        zheimer’s.                   pany’s  founders  include  formula that includes age,  science  chief  at  the  U.S.
            Independent  experts  are  “I  now  have  an  answer,”  Drs.  David  Holtzman  and  and  patients  are  given  a  National Institute on Aging,
            leery  because  key  test  re-  said the 63-year-old former  Randall Bateman of Wash-  score  suggesting  low,  me-  said the government fund-
            sults  have  not  been  pub-  nurse  from  San  Jose,  Cali-  ington  University  School  of  dium  or  high  likelihood  of  ed some of the work lead-
            lished and the test has not  fornia.                      Medicine, who headed re-     having  amyloid  buildup  in  ing  to  the  test  as  well  as
            been approved by the U.S.  If  a  blood  test  had  been  search that led to the test  the brain.                   other kinds of blood tests.
            Food and Drug Administra-    available,  “I  might  have  and are included on a pat-   If the test puts them in the  “I would be cautious about
            tion  —  it’s  being  sold  un-  been  afraid  of  the  results”  ent that the St. Louis univer-  low category, “it’s a strong  interpreting  any  of  these
            der  more  general  rules  for  but  would  have  “jumped  sity licensed to C2N.       reason  to  look  for  other  things,” he said of the com-
            commercial  labs.  But  they  on  that”  to  find  out,  she  ABOUT THE TEST           things” besides Alzheimer’s,  pany’s  claims.  “We’re  en-
                                         said.                        The test is not intended for  Bateman said.               couraged,  we’re  interest-
                                         More than 5 million people  general  screening  or  for  “There  are  a  thousand  ed, we’re funding this work
                                         in  the  United  States  and  people  without  symptoms  things  that  can  cause  but we want to see results.”
                                         millions  more  around  the  — it’s aimed at people 60  someone to be cognitively  Heather  Snyder  of  the  Al-
                                         world have Alzheimer’s, the  and older who are having  impaired,” from vitamin de-     zheimer’s  Association  said
                                         most common form of de-      thinking  problems  and  are  ficiencies  to  medications,  it won’t endorse a test with-
                                         mentia.  To  be  diagnosed  being  evaluated  for  Al-    Holtzman said.               out FDA approval. The test
                                         with  it,  people  must  have  zheimer’s.  It’s  not  covered  “I don’t think this is any dif-  also needs to be studied in
                                         symptoms  such  as  memo-    by  insurance  or  Medicare;  ferent  than  the  testing  we  larger and diverse popula-
                                         ry  loss  plus  evidence  of  a  the   company   charges  do  now”  except  it’s  from  tions.
                                         buildup of a protein called  $1,250 and offers discounts  a blood test rather than a  “It’s  not  quite  clear  how
                                         beta-amyloid in the brain.   based  on  income.  Only  brain  scan,  he  said.  “And  accurate  or  generalizable
                                         The best way now to mea-     doctors can order the test  those  are  not  100%  accu-  the results are,” she said.q
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