ProLung Test 2018-06-11T09:55:09+00:00
PROVIDER FAQ
PATIENT FAQ

The ProLung Test:
Making the Difference in Time

The ProLung Test uses precision proprietary volume-averaging bioconductance technology to measure the difference in conductivity between malignant and benign lung tissue. The data is analyzed to produce a personalized and predictive score indicating the likelihood that a particular lesion in the lungs is malignant.

There is a severe unmet clinical need to reduce the time required to determine malignancy in patients diagnosed with Indeterminate Pulmonary Nodules (IPNs). Patients with IPNs may wait months, or even years, receiving multiple CT scans to identify malignancy in the lungs, when present.1 This wait often proves fatal.

In 2015, the US Preventative Services Task Force and Centers for Medicare and Medicaid Services (CMS) added annual screening for lung cancer with low dose computed tomography (LDCT) as a covered Medicare benefit for patients meeting certain criteria.2 This new Medicare benefit will facilitate the identification of an additional 22 million patients with pulmonary lesions of indeterminate significance.1

1 National Lung Screening Trial Research Team (NLST). Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. N Engl J Med 2011; 365:395-409 (full text)
2 Centers for Medicare & Medicaid Services (full text)

The ProLung Test has the potential to reduce the “watchful waiting” time from up to 3 years to 1 day.*

FEATURES:

  • Non-invasive

  • No radiation

  • Under 30-minute test

BENEFITS:

  • Rapid results

  • Risk stratification

  • Peace of mind

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Product Catalog

ProLung® System

ProLung System, part of a predictive analytic technology for rapid risk stratification of lung cancer.

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Product Number

ProLung System – PL1000*

Call +1.801.736.0729 to order.

Country Variants (Language)
USA* (English)
GER, AUT (Deutsch)
ITA (Italiano)
ESP (Español)
FRA (Français)
GBR, IRL (English)
CHE (Italiano)
CHE (Français)
CHE (Deutsch)
BEL (English)
BEL (Français)
FIN (Suomi)
NOR (Norsk)
SWE (Svenska)
DNK (Dansk)
TUR (Türkçe)
PRT (Português)
LUX (Lëtzebuergesch)
SVK (Slovenčina)
CZE (Čeština)
POL (Polski)
NLD (Nederlands)

ProLung Device

ProLung Probe
– Electrode Cable

ProLung Tower
– Tower Assembly
– Keyboard (regional)
– Monitor
– Power Cables (regional)
– Sponge Cup

Dimensions:
24″ x 24″ x 58″
(61 cm x 61 cm x 147 cm)

Weight:
100 lbs
(45 kg)

Measurements are approximate.

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ProLung Test Kit

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ProLung Test Kit, part of a predictive analytic technology for rapid risk stratification of lung cancer.

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Product Number

ProLung Test Kit – PL2000*

Quantities available in multiples of ten kits (one box).

Call +1.801.736.0729 to order.

In each kit:

ProLung Test Key
ProLung Probe Tip & Tip Cover
ProLung Electrodes (x6)
ProLung Sponge

Single ProLung Test Kit

Dimensions:
13.68” x 5.51” x 1.00”
(34.75 cm x 14.00 cm x 2.54 cm)

Weight:
1.29 oz (36.80 g)

One Box (10 kits)

Dimensions:
8.55” x 7.10” x 5.20”
(21.72 cm x 18.03 cm x 13.21 cm)

Weight:
16.40 oz (464.7 g)

Measurements are approximate.

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Download Complete Product Catalog*
ProLung System Technical Data Sheet*

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ProLung Test Kit Technical Data Sheet*

The Current Standard of Care

INDETERMINATE NODULES AND LUNG CANCER DETECTION

In most cases, a nodule is discovered incidentally following a computerized tomography (CT) scan or through a chest CT screen. The patient then undergoes one of two methods for follow-up:1

The nodule is monitored for growth using repeated CT scans every three to six months for 3½ years. This exposes the patient to radiation and carries a high potential for false positive results, which may subsequently lead to unnecessary biopsies and procedures.

The nodule may also be monitired using Positron-Emission Tomography (PET) scans over a similar period of 3 years. This method has numerous limitations, however, depending on the size, inflammation levels, and metabolic activity of the tumor.

After sufficient risk is finally confirmed from repeat CT or PET scans, a biopsy is performed and a tissue diagnosis is made.

1 Current NCCN Guidelines, version 1.2017; Lung-RADS; Fleischner Society Guidelines(full text)

Repeated CT scans may be replaced by the ProLung Test, a predictive analytic technology for rapid risk stratification of lung cancer.

EU Intended Use and Indications for Use

Intended Use

The ProLung Device is a computer‐controlled, non-invasive, electrical bioconductance measurement system comprised of an instrument body, a data acquisition probe, and a reference electrode which delivers low level electrical current at specified bilateral anatomic locations on the human body. The integrated computer system provides a screen display of real‐time measurements during operation, regulates probe performance, collects and analyzes data.

Indications for Use

The ProLung Device is indicated for use in patients who have undergone computed tomography (CT) in which a pulmonary lesion of indeterminate significance has been detected. The ProLung Test™ is indicated for use as an aid in the risk stratification of such patients for the occurrence of lung cancer. Patients with elevated ProLung Test Scores are at an increased risk of developing lung cancer.

The ProLung Test is only available for purchase in the European Economic Area and European Free Trade Association Countries and is for investigational use only in the US.*

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