Why choose NavDx®
Professional resources
Why TTMV® matters
Request a follow-up
NavDx®: A novel test

Why choose NavDx®

NavDx is the first and only clinically validated circulating tumor-tissue–modified HPV (TTMV®) DNA blood test that aids in the detection of HPV-driven cancers.1

 

This highly accurate blood test uncovers the presence of HPV+ head and neck cancer across the care continuum by quantifying circulating fragments of TTMV HPV DNA that are shed by tumor cells into the blood.2

 

NavDx can reliably confirm the HPV genotype and establish baseline TTMV HPV DNA level pretreatment, assess treatment response, identify molecular residual disease post treatment, and detect recurrence significantly earlier than it would present clinically.1

 

    • NavDx has a 100% negative predictive value (NPV) and a 94% positive predictive value (PPV) for active HPV-driven malignancy1
    • NavDx identifies the presence of molecular residual disease post treatment so physicians can prioritize appropriate patients for adjuvant or follow-on treatment1
    • NavDx can accurately detect recurrence a median of 4 months earlier than imaging and biopsy1

NavDx is an innovative and accessible blood test that enables you to optimize HPV-driven cancer care and reassure patients that their disease is being effectively monitored.1

References:

 

1. Chera BS, Kumar S, Shen C, et al. Plasma circulating tumor HPV DNA for the surveillance of
cancer recurrence in HPV-associated oropharyngeal cancer. J Clin Oncol. 2020;38(10):1050-1058.

2. Chera BS, Kumar S, Beaty BT, et al. Rapid clearance profile of plasma circulating tumor HPV
type 16 DNA during chemoradiotherapy correlates with disease control in HPV-associated
oropharyngeal cancer. Clin Cancer Res. 2019;25(15):4682-4690.

Professional resources

The following resources are designed to help seamlessly incorporate NavDx® into your practice.

A quick guide to NavDxWhat a NavDx Results Report tells youOrdering NavDx made easy

Why TTMV® matters

NavDx® uses proprietary technology to quantify fragments of circulating tumor-tissue–modified HPV (TTMV) DNA, a unique HPV-driven cancer biomarker that tumor cells shed into the blood. This highly accurate blood test reliably uncovers the presence of HPV+ head and neck cancer across the care continuum by distinguishing TTMV HPV DNA from non-cancerous sources of HPV DNA.1-2

 

NavDx helps inform clinical decisions by:

 

  • Confirming the tumor HPV genotype1
  • Assessing current treatment response2
  • Identifying molecular residual disease post treatment2
  • Detecting recurrence earlier than it would appear on imaging scans2

This innovative and accessible blood test enables you to optimize HPV-driven cancer care and reassure your patients that their disease is being effectively monitored.2

References

 

1. Chera BS, Kumar S, Beaty BT, et al. Rapid clearance profile of plasma circulating tumor HPV type 16 DNA during chemoradiotherapy correlates with disease control in HPV-associated oropharyngeal cancer. Clin Cancer Res. 2019;25(15):4682-4690. 2. Chera BS, Kumar S, Shen C, et al. Plasma circulating tumor HPV DNA for the surveillance of cancer recurrence in HPV-associated oropharyngeal cancer. J Clin Oncol. 2020;38(10):1050-1058.

Request a follow-up

Thank you for stopping by our virtual booth. If you would like to speak with a NavDx® representative, and receive more information, please complete the form to get started.

Request a follow-up

NavDx®: A novel test

© 2021 Naveris Inc., All rights reserved.
Privacy Policy | Notice of Privacy Practices Under HIPAA
NavDx-0621-112

This experience is designed for larger screens.

To experience this site as intended please make your browser window larger or view it on a tablet, laptop, or desktop screen.

Proceed on smaller screen

Important Safety Information
Return to Exhibit
Indications

BARHEMSYS is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for:

  • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
  • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis
Important Safety Information
Contraindication

BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation

BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.

Avoid BARHEMSYS in patients with congenital long QT syndrome and in patients taking droperidol.

Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions

Common adverse reactions reported in ≥ 2% of adult patients who received BARHEMSYS 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).

Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of BARHEMSYS-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.

The most common adverse reaction, reported in ≥ 2% of adult patients who received BARHEMSYS 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Use in Specific Populations

Lactation
Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.

BARHEMSYS may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after BARHEMSYS treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.

To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of BARHEMSYS.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The pharmacokinetics of amisulpride in patients with severe renal impairment have not been adequately studied in clinical trials. Amisulpride is known to be substantially excreted by the kidneys, and patients with severe renal impairment may have increased systemic exposure and an increased risk of adverse reactions.

No dosage adjustment is necessary in patients with mild to moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2).

Drug Interactions
  • BARHEMSYS causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of BARHEMSYS in patients taking droperidol.
  • ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
  • Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and BARHEMSYS. Avoid using levodopa with BARHEMSYS.
Please click to access full Prescribing Information.

BAR HCP ISI 02/2020