Coalition for Innovative Lab Testing

Thanks for your interest and support. Please read and sign the following letter to Congress.

Hon. Patty Murray
Chairman, Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Bldg.
Washington, D.C. 20510

Hon. Frank Pallone Jr.
Chairman, House Energy and Commerce Committee
2125 Rayburn House Office Bldg.
Washington, D.C. 20515

Hon. Richard Burr
Ranking Member, Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Bldg.
Washington, D.C. 20510

Hon. Cathy McMorris Rodgers
Ranking Member, House Energy and Commerce Committee
2125 Rayburn House Office Bldg.
Washington, D.C. 20515

Re:       VALID Act of 2021 (S. 2209; H.R. 4128)

Distinguished Members of Congress:

The undersigned are leaders of clinical laboratories and diagnostics companies from throughout the U.S. that develop innovative lab tests across the disease spectrum.

We write to express our deep concern that the regulations that would be implemented under the VALID Act would impose tremendous and wholly unnecessary burdens on labs. Smaller laboratories would be forced to abandon development and commercialization of tests that could otherwise improve patient outcomes and reduce healthcare costs. Many labs will be forced to downsize, and some will close leaving our nation unprepared for future Covid variants or new pandemics.

Under current CLIA rules the performance of lab developed tests (LDTs) are subject to extensive controls and ongoing inspection and accreditation requirements from the states and CMS, which maintain the quality of the laboratory’s testing products and processes. Congress should proceed slowly and with great caution before adding FDA approvals over LDTs, while soliciting significant input from smaller labs and companies that would be profoundly impacted by this legislation. In particular, the costs of any new regulations should to be quantified as should the consequences of these increased costs on the healthcare system due to the inevitable reduction in competition and innovation reaching the marketplace.

Before taking up the VALID Act it would be prudent first thoroughly assess the impacts of FDA test regulation during the pandemic. Many experts have harshly criticized the FDA’s role in slowing introduction of COVID-19 tests throughout the pandemic and the resulting deaths and disease spread stemming from these delays. An NIH funded report on this “testing debacle” published in the Yale Law Journal concluded that FDA imposed delays “potentially foreclosed opportunities to arrest widespread community transmission of the disease” and was “possibly the deadliest regulatory overreach in U.S. history.” This debacle could become a mere harbinger of things to come should S. 2209; H.R. 4128 become law.

Moreover, as the CDC’s Clinical Laboratory Improvement Advisory Committee (CLIAC) is now examining updates to the CLIA rules for LDTs, that effort should be giving time before FDA oversight of these tests is imposed.

For the forgoing reasons we urge that consideration of the VALID Act be suspended to provide time for both a full pandemic review and to examine whether updates to the CLIA rules might obviate the need for expanding FDA’s authority.

Thank you for considering our perspectives and recommendations.

Respectfully submitted,

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Current Signatories

Name:Otto Schaefer

Company Name:Advanced Pathways Consulting


Company Address3817 Wingtail Way
Pearland, Texas 77584
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Name:Jessica Moorehous

Company Name:Genomind

Title:Clinical Advisor

Company Address601 E Pete Rose Way
UNIT 758
Cincinnati, Ohio 45202
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Name:Colleen Sandler

Company Name:Long and Foster

Title:Sales Agent

Company Address503 Post Oak Road
ANNAPOLIS, Maryland 21401-7141
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Name:Mick Ruxin, M.D.

Company Name:Theralink Technologies, Inc


Company Address15000 W. 6th Ave., Ste #400
Golden, Colorado 80401
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Name:Natasha Villanueva

Company Name:MAWD Pathology Group

Title:Vice President of Clinical Laboratory

Company Address11070 Strang Line Rd
Lenexa, Kansas 66215
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Company Name:Innovative GX Laboratories


Company Address5410 Fredericksburg Rd.
300 Allston St. #108
SAN ANTONIO, Texas 78229
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Name:Bruce Davis

Company Name:Bruce H Davis MD, Inc

Title:Principal, Retired Pathologist and IVD assay developer

Company Address700 Trillium Lane
Clifton, Maine 04428
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Name:Larry Mitchells

Company Name:Exceptional Cleaners

Title:Follow Up

Company AddressCedar Springs Rd Dallas, TX 75219
Cedar Springs Rd Dallas, TX 75219
Sacramento, Texas 75219
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Name:Larry Mitchells

Company Name:Exceptional Cleaners

Title:Cleaning Proposal

Company AddressCedar Springs Rd Dallas, TX 75219
Dallas, Texas 75219
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Name:Lindsay Strotman

Company Name:Throughbred Diagnostics

Title:Lab Director

Company Address137 N PETERSON AVE
Louisville, Kentucky 40206
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Name:Lale White

Company Name:XIFIN, Inc.


Company Address12225 El Camino Real
San Diego, California 92130
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Name:Ryan Fortna

Company Name:Northwest Pathology, P.S.


Company Address3560 Meridian St., Suite 101
Bellingham, Washington 98225
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Name:Matt Watson

Company Name:Northwest Pathology, P.S.

Title:Chief Executive Officer

Company Address3560 Meridian Street, Suite 101
Bellingham, Washington 98225
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Name:Sam (Sombabu) Mullapudi

Company Name:CIAN Diagnostics


Company Address5330 Spectrum Drive, Suite I
Frederick, Maryland 21703
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Name:Shoeb Ahmad

Company Name:myGenomics


Company Address11535 Park Woods Circle, Ste. E,
Alpharetta, Georgia 30005
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Name:Trent McCallson

Company Name:InHealth


Company Address40 Enterprise Blvd
Bozeman, Montana 59718
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Name:Javid Wani

Company Name:BioCentra LLC


Company Address5600 S Willow Dr Ste 101
Houston, Texas 77035
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Name:Andrea HO

Company Name:8029 s. williams way


Company Address8029 S. Williams Way
Centennial, Colorado 80122
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Name:Kalisha Hill



Company Address1622 Brassie Ave
Flossmoor, Illinois 60422
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Name:Jonathan Harol

Company Name:Lighthouse Lab Services


Company Address404 Fire Opal Lane
Holly Springs, North Carolina 27540
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Name:Jesse Greer

Company Name:Saguaro Bloom

Title:Lab Director

Company Address4224 N Craftsman Ct
Scottsdale, Arizona 85251
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Name:Michael Bergevin, M.D.

Company Name:MJB & Associates, Inc.

Title:Medical Laboratory Consultant

Company Address109 N JAMES LANDING CT
SMITHFIELD, Virginia 23430
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Name:Marvin Lessig

Company Name:Summit Medical

Title:Lab Director

Company Address150 Park Ave
Florham Park, New Jersey 07932
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Name:Angie Purvis

Company Name:Angie Purvis, LLC


Company Address7664 Brook Forest Lane
Evergreen, Colorado 80439
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Name:Michelel Carbone

Company Name:MPC Laboraory Consult


Company Address2 Barkentine Road
Rancho Palos Verdes, California 90275
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Name:Thomas Alexander

Company Name:FlowMetric Diagnostics

Title:Clinical Laboratory Director

Company Address3805 Old Easton Rd
Doylestown,, Pennsylvania 18902
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Name:Matthew Chambers

Company Name:Beechtree Diagnostics & Beechtree Molecular Lab

Title:CEO Emeritus

Company Address12351 S. Gateway Park Place, Suite D-700
Draper, Utah 84020-9581
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Name:Jarrod Holman

Company Name:Lifetime Sciences

Title:SVP of Sales

Company Address4037 Rural Plains Circle
Suite 150
Franklin, Tennessee 37064
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Name:Hugo Saavedra

Company Name:KYAN Therapeutics


Company Address23901 Calabasas Road
Suite 1010
Calabasas, California 91302-3308
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Name:Richard Wasserman

Company Name:Allergy Partners of North Texas


Company Address7777 Forest Lane B-332
Dallas, Texas 75230
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Name:Jacob Klein

Company Name:Genetic Technological Innovations

Title:Chief Scientific Officer, Technical Supervisor

Company Address13402 North Scottsdale Rd. B-185
Scottsdale, Arizona 85254
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Name:Donald McNeil MD

Company Name:Optimed Research Ltd


Company AddressSuite 200
8080 Ravines Edge Ct
Columbus, Ohio 43235
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Name:Jacob Offenberger

Company Name:Allergy and asthma


Company Address10515 balboa blvd
10515 balboa
Granada hills, California 91344
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Name:Ozlem Goker -Alpan

Company Name:LDRTC


Company Address3702 Pender drive
Fairfax, Virginia 22030
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Name:Ahmet Aybar

Company Name:Annapolis Pediatric Gastroenterology


Company Address130 Lubrano Dr
Ste 212
Annapolis, Maryland 21401
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Name:Matthew Plassmeyer

Company Name:Amerimmune

Title:Technical Director

Company Address8260 Greensboro Dr
McLean, Virginia 22102
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Name:Victor Nava

Company Name:Amerimmune


Company Address11212 Waples Mills Rd Ste 100
Fairfax, Virginia 22102
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Name:Laura Ispas

Company Name:Allergy Asthma & Inmunology Institute


Company Address19455 Deerfield Ave
Suite 207
Lansdowne, Virginia 20176
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Name:Amy Darter

Company Name:oklahoma institute of Allergy, ASthma, Immunology


Company Address1810 East Memorial Road
Oklahoma City, Oklahoma 73131
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Company Address23 S Howell Ave
Suites O-P
Centereach, New York 11720
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Name:Akimyo Russell

Company Name:Metroimmune


Company Address3118 Omega Pl
Waldorf, Maryland 20603
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Name:Hasan Abdallah

Company Name:Children’s Heart Institute


Company Address171 Elden street
Herndon, Virginia 20170
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Name:Theodore Kim

Company Name:Allergy Partners of Northern Virginia

Title:Principal Physician

Company Address14520 Avion Parkway, Suite 150
Chantilly, Virginia 20151
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Name:Soren Ulrik Sonder

Company Name:Amerimmune

Title:Senior scientist

Company Address8260 Greensboro dr
McLean, Virginia 22102
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Name:Michael Abdin

Company Name:Metropolitans ENT


Company Address6355 walker lane. Suite 308
Alexandria, Virginia 22310
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Name:Oral Alpan

Company Name:Amerimmune


Company Address8260 Greensboro Dr
McLean, Virginia 22102
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Name:Rohan Nath



Company Address2817 MILLER RANCH ROAD
PEARLAND, Texas 77584
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Name:Sheena Menezes, PhD

Company Name:Simple HealthKit


Company Address46421 Landing Parkway
Los Gatos, California 95032
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Name:Chih-Ling Zao

Company Name:Plexus Dx

Title:CLIA Laboratory Director

Company Address11300 Johns Creek Parkway, Suite 300
Duluth, Georgia 30097
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Name:Ivan Santos

Company Name:Amerimmune Diagnostics LLC


Company Address8260 Greensboro Drive Suite A-30
McLean, Virginia 22102
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Name:Catherine Dumur

Company Name:Bernhardt Labs

Title:Director of Molecular Diagnostics

Company Address3728 Philips Highway
Suite 64
Jacksonville, Florida 32207
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Name:William Sims

Company Name:PreciseMDX

Title:VP Sales

Company Address911 N Brookshade Pkwy
Milton, Georgia 30004
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Name:Amanda Elam

Company Name:Galaxy Diagnostics, Inc.


Company Address6 Davis Dr, Suite 201
PO Box 14346
Research Triangle Pa, North Carolina 27709
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Name:Francis Amato

Company Name:Synaps Dx


Company Address12358 Parklawn Dr
North Bethesda, Maryland 20895
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Name:Douglas Toal

Company Name:Douglas Toal, PhD, D(ABMM), LLC

Title:Laboratory Director Consultant

Company Address47 North Main Street
Belmont, North Carolina 28012
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Name:Indira Poola

Company Name:Silbiotech, Inc.


Company Address15807 Chagall Ter
Gaithersburg, Maryland 20878
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Name:Lawrence Worden

Company Name:IVD Logix LLC


Company Address2019 Old Orchard Drive
Dallas, Texas 75208
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Name:Jonathan Stein

Company Name:Gene By Gene

Title:Medical Director

Company Address1445 N Loop W Suite 820, Houston, TX 77008
Houston, Texas 77043
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Name:Concetta Bormans

Company Name:Gene By Gene

Title:Chief Laboratory Officer

Company Address1445 N Loop W
Suite 820
Houston, Texas 77008
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Name:Cha-Mei Tang

Company Name:Creatv MicroTech, Inc.

Title:President and CEO

Company Address9900 Belward Campus Drive
Suite 330
Rockville, Maryland 20850
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Name:Fritz Gartner

Company Name:ADx Health


Company Address3560 Meridian St Ste 100
Bellingham, Washington 98225
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Name:Jeremy Kahn

Company Name:GTI Laboratories

Title:Managing partner

Company Address14500 N Northsight Blvd suite 100
Suite 100, Arizona 85260
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Name:Thomas Tiffany

Company Name:Private Healthcare Consultant - retired CEO

Title:Former Lab CEO Retired

Company Address6618 S. Westchester Dr.
Spokane, Washington 99223
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Name:Nick Glimcher

Company Name:GTI


Company Address14500 n northsight blvd suite 100
Scottsdale, Arizona 85260
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Name:Chang H Kim

Company Name:GoDx


Company AddressGODX 510 CHARMANY DR STE 265 MADISON WI 53719-1293
Madison, Wisconsin 537191293
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Name:Michael Bauer

Company Name:Michael J. Bauer, MD and Associates, Inc.


Company Address200 S Wilcox St
Suite 443
Castle Rock, Colorado 80104
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Name:Matthew Chambers

Company Name:Beechtree Diagnostics LLP

Title:Senior Advisor

Company Address4526 W 3100 S54
West Valley City, Utah 84120
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Name:Bradley Walsh

Company Name:Minomic Inc.


Company Address1644 Plattee Street - Suite 400
Denver, Colorado 80202
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Name:Jonathan Cohen

Company Name:20/20 GeneSystems, Inc.

Title:President & CEO

Company Address15810 Gaither Dr. Suite 235
Gaithersburg, Maryland 20877
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Name:Christiaan Engstrom

Company Name:Veravas

Title:VP, Channel Dev

Company Address3510 Hopkins Pl
Oakdale, Michigan 55128
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Name:Harry Forsyth Harry

Company Name:Analytik Jena


Company AddressTampa, Florida
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Name:Mohmed Ashmaig

Company Name:MarinaBioLab


Name:Matt Riccio

Company Name:Aptar

Title:Bus development

Company Address960 Veterans Boulevard
Auburn, Alabama 36832
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Name:Andrew Orr

Company Name:Opti


Company Address235 Hembree Park Drive
Roswell, Georgia 30076
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Name:Ross Ross

Company Name:Sght


Company AddressJacksonville Beach, Florida
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Name:Meredith holt

Company Name:Hh


Name:Sasha Bairmov

Company Name:KMC


Company Address220 Daniel Webster Highway
Merrimack, New Hampshire 03054
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Name:Peter Simms

Company Name:Silver State Diagnostics


Company Address3281 N Decatur BLVD STE 150
Las Vegas, Nevada 89130
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