www.MachaonDiagnostics.com

vWD-CompleteTM von Willebrand Disease

Genetic Panel

1-weekTurnaround

Time(fastest in the US)

- Diagnose and subtype in 1 week or less- Diagnose Platelet or Pseudo-vWD- Available across US (FedEx Service Area)

- Draw Kits (includes free shipping)

- Clinical consultation from hematologist- Functional confirmation of variants

Turnaround Time:1 weekSTAT Turnaround Time:48 hours (M-F)Methodology: Next Generation Sequencing (NGS)Price:$1,978 (STAT Fee is $700)

Note:Medicarereimbursement currently covers the cost forthistest in the outpatient setting (06DEC2017).

AdditionalInformationSpecimen: 3mL EDTA whole blood Alternative Specimen: buccal swab Stability: >1 month at 2-25°CCPT Code: 81479, 81408Days Run: Monday - Friday, variesReflex: vWF Profile with Multimer

Machaon Diagnostics, Inc. 3023 Summit Street Oakland, CA 94609

Phone : 510-839-5600 Fax: 510-839-6153E-mail: info@machaondiagnostics.com

STAT results in 48 Hours (M-F)

TOLL FREE 1-800-566-3462

Machaon Diagnostics is a clinical reference laboratory, specializing in the diagnosis, treatment and monitoring of hemostatic and thrombotic conditions. We strive to be your fastest resource for the laboratory testing of bleeding and clotting patients.

Draw kits with free priority overnight shipping available. Call for kits.

BackgroundRemarkably, classical von Willebrand disease (vWD) laboratory work-ups have been shown to require repeat laboratory testing 1 to 20 times to confirm diagnosis [1]. Furthermore, most diagnostic laboratory algorithms terminate with molecular confirmation [2, 3]. Machaon Diagnostics is pleased to be pioneering a new test that will diagnose and subtype von Willebrand disease (vWD) and pseudo- or platelet-type vWD within 1 week (or 48 hours, STAT). The clinical sensitivity of this test is approximately 85% for subtypes 2A, 2B, 2N, 2M and 3 vWD [4].

Previously, no one test was able to diagnose vWD. Classical laboratory work-ups include aPTT, factor VIII (8) activity, Ristocetin cofactor activity, vWF antigen, ratio calculations, multimeric composition and others. Each of these tests is influenced by numerous factors, such as inflammation, stress, infection, hormone replacement therapy, age, acute phase response, menstrual cycle, pregnancy exercise, ABO blood type, lupus anticoagulant and other factors, making traditional diagnosis a challenging moving target [3, 5, 6].

vWD occurs with bleeding symptoms at rate of 1 in 1,000 in the general population [6]. In 10% of those cases the bleeding is severe [3]. This prevalence makes vWD the most common congenital bleeding disorder known [6].

Acquired vWD (1-5% of cases) can be assessed with Machaon Diagnostics’ von Willebrand Profile tested in our comprehensive coagulation and platelet laboratory.

See our PlateletGenex Functional Defect Panel to evaluate contribution of platelet defects to bleeding symptoms.

References: 1.) Kirtava A et al. Haemophilia 2004; 10(2): 158-161; 2.) Federici, AB. Int Jnl Lab Hem 2016; 38(Suppl.1): 41-49; 3.) Leebeek, FWG and Eikenboom, JCJ. NEJM2016; 375(21): 2067-2080; 4.) James PD and Lillicrap, D.Br J Haematol 2013; 161: 166-176; 5.) James AH et al.Haemophilia 2016; 22(Suppl. 5): 54-59; 6.) Lillicrap D andJames, P. World Federation of Hemophilia 2009; No. 47.

Genes sequences: VWF and GP1BA

Machaon Diagnostics Medical Director: Brad H. Lewis, MD

3023 Summit Street, Oakland, CA 94609

Phone: (510) 839-5600 Fax: (510) 839-6153

vWD-CompleteTM Genetic Panel STAT Turnaround Time: 48 hours, M-F / Routine Turnaround Time: 1 week

www.MachaonDiagnostics.com 1-800-566-3462

PATIENT INFORMATION (complete or attach) SUBMITTING FACILITY Patient’s Name: (Last, First, M.I.) Gender: (ci rcle one)

M / F

Facility Phone Number: Fax Number for Results:

Specimen Date: (MM/DD/YY) Time: AM / PM Date of Birth: (MM/DD/YY)

Medical Record / ID#: Patient’s Social Security #:

ORDERING PHYSICIAN INFORMATION BILLING INFORMATION Physician’s Name: (Last, First, M.I.) Physician’s NPI:

Bill to: □ Facility / Inpatient of Outpatient

Contact Phone Number: Fax Number for Results: Bill to: □ Insurance / Outpatient

Currently, there is no payable outpatient benefit from Medicaid for this test.

Physician’s direct phone number to call results: (high ly encouraged) □ STAT Samples shipped for weekend arrival must be ordered STAT. Mark FedEx Airbill for ‘SATURDAY Delivery.’

CLINICAL INFORMATION (if available) TEST SELECTION Platelet defect present? Yes / No

Note: Please attach most recent platelet aggregation report.

Has this patient had a bone marrow transplant?

Yes / No / unknown □ vWD-Complete TM von Willebrand Disease Genetic Panel

Methodology:

Rapid Next Generation

sequencing of 2genes PLT Count: ______ (K/µL)

Hemoglobin: _____ (mg/dL)

Fibrinogen: _____ (mg/dL)

PFA-100 Results: Normal / Abnormal

vWF Profile Results: Normal / Abnormal

Circle abnormal platelet agonists: Ristocetin high-doseRistocetin low-dose Genes included: VWF and GP1BA

Ethnicity: (circle one) European, African, Latino, East Asian,

South Asian or other:____________________________________ □ Functional Confirmation with vWF Profile with Multimer

Please separately ship 2 x 1mL aliquots of frozen citrated plasma to our Oakland laboratory.

Specimen Collection, Processing and Shipping / call for draw kits (free shipping included) 1. Draw 1 lavender top tube (EDTA) and store and ship at room temperature. 6. Place all forms into document sleeve of the biohazard bag.2. Mix tube by inversion, gently to ensure proper mixing. 7. Ensure that no patient-specific information is visible. 3. Label tube with patient first and last name, draw date and DOB. 8. Place biohazard bag into the provided FedEx Clinical Pak.4. Enclose tube in Styrofoam box and seal in biohazard bag. 9. Complete the provided FexEx Airbill and affix Airbill pouch to Pak.5. Complete this form and attach insurance billing information. 10. Call FedEx 800-238-5355 for a pick-up.

Patient Declination: □ No; I do not authorize Machaon Diagnostics to use your deidentified laboratory data and sample forresearch to learn more about rare bleeding and clotting disorders and facilitate the education of our physician clients.

OUTPATIENT ONLY: INSURANCE BILLING INFORMATION (complete or attach) Insurance Company: (Medicare patients must sign an ABN) Patient Address: Patient Phone Number:

Insurance Policy / Medicare Number: Insurance Group Number: Patient City: State: Zip Code:

Insurance Company Address: Authorization Number: OUTPATIENT ONLY: PATIENT SIGNATURE Insurance Company City: State: Zip Code:

DIAGNOSIS CODE(S): (Please complete medical necessity form.)

ICD-10 Code: ICD-10 Code: ICD-10 Code: Patient’s Signature:

X: Date: . ADDITIONAL INFORMATION

Machaon Diagnostics is a specialized coagulation and platelet laboratory that provides comprehensive clinical evaluations of bleeding and clotting patients. Most evaluations can be completed within 24 hours, 7 days a week. Machaon Diagnostics is a California-licensed, CLIA-accredited, CAP-accredited, clinical laboratory approved to provide high-complexity testing services. This test is not covered or reimbursed by Medicaid. All patients are considered OUT-OF-NETWORK and will be billed for services not covered by their insurance provider. Medicare patients must sign an ABN, either located on the reverse side of this form or downloaded from the Machaon Diagnostics website. Patient insurance billing services are provided in accordance with the Machaon Insurance Billing Policy. HMO or medical group covered patients may need a prior authorization if they seek full reimbursement. For more information please visit www.MachaonDiagnostics.com or call (510) 839-5600.

MDI Use: (Order number): _______________________ (Number of aliquots): __________________ Version:06DEC2017

Machaon Diagnostics may need to obtain additional information from your physician to complete these services. I hereby authorize the release of medical information related to the services described herein and authorize payment directly to Machaon Diagnostics. This test is currently not covered or reimbursed by Medicaid. This panel is $1,978 and if ordered STAT, adds $700; shipping charges may apply. I agree to assume responsibility for payment of all charges not covered by my healthcare insurer.