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About Hologic Gen-Probe

aboutGen-Probe Incorporated is now part of Hologic Incorporated. Hologic and Gen-Probe have joined forces to create Hologic’s diagnostics business. This business is dedicated to saving lives through early detection, improved diagnosis and less invasive treatment.

Hologic Gen-Probe is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility.

Hologic Gen-Probe has nearly three decades of molecular diagnostics expertise, and received the 2004 National Medal of Technology, America’s highest honor for technological innovation, for developing molecular assays and systems that help safeguard the blood supply.

DTS SYSTEM

Now more than ever, laboratories need testing solutions that are accurate, efficient and economical. To achieve the greatest levels of accuracy, testing solutions need to work seamlessly together. To meet this demand, Hologic Gen-Probe has developed the family of DTS Systems. These systems include the DTS 400, DTS 800, and DTS 1600. This full line of automated solutions for low-, medium- and high-volume laboratories can be used with the following Hologic Gen-Probe assays:

APTIMA COMBO 2 Assay – One test/two results – to differentiate and detect Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC)

APTIMA CT Assay – Single analyte for individual supplemental testing

APTIMA GC Assay – Single analyte for individual supplemental testing

APTIMA HPV Assay – For the detection of E6/E7 mRNA from 14 high-risk types+

APTIMA HCV RNA Qualitative Assay – Used to detect active infection by directly detecting viral RNA and to identify the endpoint of infection following antiviral treatment*++

APTIMA HIV-1 RNA Qualitative Assay – Used to detect HIV infection before the appearance of antibodies*++

PROGENSA PCA3 Assay – Prostate cancer-specific gene to quantify the PCA3 mRNA in urine+

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LEADER SYSTEM

Hologic Gen-Probe’s LEADER family of luminometers is designed to detect chemiluminescent emissions from a wide range of sample types and quantities. Capable of processing up to 250 samples at a time, LEADER luminometers provide an automated photon-counting luminometer with both the sensitivity and the flexibility to perform virtually any luminescent assay. The LEADER HC+ instrument provides an automated platform for Hologic Gen-Probe’s APTIMA nucleic acid amplification tests. Designed to work with the PACE, ACCUPROBE and GASDirect non-amplified DNA assays, the LEADER 50i and 450i instruments provide the ideal detection system for sensitivity, speed, accuracy and ease of use.

Description

Quantity

Catalog

LEADER HC+ Luminometer
For analyzing chemiluminescent assays.
1 104747
LEADER 450i Luminometer
For analyzing chemiluminescent assays.
1 103200i
LEADER 50i Luminometer
For analyzing chemiluminescent assays.
110V
220V
1
1
105194
103100i-02
LEADER Luminometer Printer Paper
Replacement paper for all LEADER instruments.
1 roll per pack 101847

 

PANTHER SYSTEM

Hologic Gen-Probe introduces the PANTHER system-designed to unleash the power and simplicity of fully automated chemistry and immunoassay instrumentation for the molecular diagnostics world. Created to be a “sample-in-result-out” instrument, the PANTHER system eliminates batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The PANTHER’s extensive list of features includes a bi-directional host interface, the ability to test multiple analytes from a single tube, positive sample identification, random access and full automation for true walkaway freedom; combined with intuitive design for ease of use-working together to help small- to medium-sized laboratories maximize operator efficiency and productivity.

The PANTHER System automates all phases of molecular diagnostics testing from sample preparation, amplification, and detection to reporting results. Integrating the PANTHER System with APTIMA assay kits for NAT offers confidence in results with true freedom from hands-on processing.

maximum productivity

Maximum Productivity

  • Random access sampling
  • Optimized workflow and throughput
  • Multiple assays processed concurrently from a single sample
  • Consolidated testing on a single platform
  • Scheduled and automated maintenance
  • STAT test prioritization*

Minimal Hands-on Time

  • Fully automated from sample to result
  • Primary tube sampling
  • Bi-directional host interface for automated download of sample test requests
  • True walkaway freedom

Flexibility

  • Continuous access to samples, reagents and consumables
  • Endpoint and real-time TMA assays*
  • On-demand sample processing
  • Load-and-go with unattended results processing
  • Stored calibration and controls every 24 hours

Ease of Use

  • Intuitive software with a guided, task-driven interface
  • Customer-driven design
  • PRO360° Remote Service Management

Confidence in Performance

  • Hardware and software process controls
  • Positive sample identification (PosID)
  • Liquid level detection
  • Reagent dispense verification
  • Radio frequency identification (RFID) tags on fluids
  • Automated inventory tracking
  • Quality control reporting
  • Contamination mitigation
  • Penetrable cap technology

TIGRIS DTS SYSTEM

The TIGRIS DTS System is the first diagnostic instrument to truly automate nucleic acid testing (NAT) from start to finish. The TIGRIS System can process approximately 450 samples in an 8-hour shift, and up to 1,000 samples in approximately 13.5 hours. Because one trained operator can run two or three TIGRIS machines simultaneously, the productivity of a single technician using the TIGRIS System could be as much as 10 times greater than a technician using other semi-automated systems.

Only the TIGRIS System automates all phases of molecular diagnostics testing from sample preparation, amplification, and detection to reporting results. Integrating the TIGRIS DTS System with APTIMA assay kits for NAT offers true freedom from hands-on processing.

Sample Preparation Freedom

  • Direct tube sampling (DTS)
  • No cap removal
  • Patient primary tubes are loaded directly on the TIGRIS DTS System
  • True positive sample identification
  • Random specimen loading
  • Worklists are created automatically
  • No need to sort patient samples in any order
  • No manual pipetting required

Sample Processing Freedom

  • Process control
  • Liquid Level Sensing confirms adequate sample and reagent levels
  • Urine and swab specimens are processed simultaneously
  • One integrated system
  • No manual transfers from processing modules to detectors
  • Walk-away simplicity equals hours of freedom

Results Analysis Freedom

  • Results are automatically linked to reagent lot numbers
  • Positive specimen results are sorted and identified for follow-up
  • Results are automatically sent to a Laboratory Information System (LIS)
  • Control Report trends performance

MICROBIAL INFECTIOUS DISEASES

AMPLIFIED MTD (Mycobacterium Tuberculosis Direct) Test

Hologic Gen-Probe’s AMPLIFIED MTD Test detects Mycobacterium tuberculosis rRNA directly and rapidly while delivering the sensitivity of culture. The test is specific for Mycobacterium tuberculosis complex. Hologic Gen-Probe’s test is the first FDA-approved direct test for helping to diagnose smear-positive and negative specimens. Recent CDC guidelines highlight the role of the Amplified MTD test in the diagnosis of a patient suspected of having TB.1

The MTD test is intended for use with specimens from patients that are showing signs and symptoms consistent with active pulmonary tuberculosis. The test is used in addition to acid fast bacillus (AFB) smear and culture. It is still important to perform culture due to the need for drug susceptibility information on isolates of Mycobacterium tuberculosis.

Description

Quantity

Catalog

AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS Direct) Test
Direct target-amplified nucleic acid probe test for the in vitro diagnostic detection of Mycobacterium tuberculosiscomplexrRNA in acid-fast bacilli (AFB) smear positive and negative concentrated sediments from sputum, bronchial specimens, or tracheal aspirates. The Mycobacterium tuberculosis complex consists of M. tuberculosisM. bovis, M. bovis BCG, M. africanum, M. canetti, and M. microti.
50 tests 301001
Hologic Gen-Probe Detection Reagent Kit
Detection reagent used on LEADER instruments for non-APTIMA branded Hologic Gen-Probe Assays.
1,200 tests 201791
Polypropylene Tubes
12 mm x 75 mm.
250 tubes per package 102440
White Press Seal Caps
Fit 12-mm tubes.
150 caps per box 901190

 

Culture Identification

The entire range of AccuProbe assays follow a standard format and use common reagents. All of the assays are based on Hologic Gen-Probe’s exclusive Hybridization Protection Assay (HPA) technology. In addition, the tests allow for the detection of target organisms from primary culture therefore eliminating the additional labor of having to purify secondary cultures. Results are obtained by utilizing Hologic Gen-Probe’s luminometers which are easy to use and offer precise readings. Convenient packaging also provides extended stability and shelf life.

Culture Identification/AccuProbe (Myco)

Description

Quantity

Catalog

AccuProbe MYCOBACTERIUM TUBERCULOSIS Complex Culture Identification Test
For the identification of Mycobacterium tuberculosiscomplex (M. tuberculosis, M. bovis, M. bovis BCG, M. africanum, M. canetti, and M. microti) isolated from culture.
20 tests 102860
AccuProbe MYCOBACTERIUM AVIUM Culture Identification Test
For the identification of Mycobacterium avium isolated from culture.
20 tests 102835
AccuProbe MYCOBACTERIUM INTRACELLULARE Culture Identification Test
For the identification of Mycobacterium intracellulareisolated from culture.
20 tests 102840
AccuProbe MYCOBACTERIUM AVIUM Complex Culture Identification Test
For the identification of Mycobacterium avium complex (M. avium, M. intracellulare, and other members) isolated from culture.
20 tests 102845
AccuProbe MYCOBACTERIUM GORDONAE Culture Identification Test
For the identification of Mycobacterium gordonae isolated from culture.
20 tests 102850
AccuProbe MYCOBACTERIUM KANSASII Culture Identification Test
For the identification of Mycobacterium kansasii isolated from culture.
20 tests 102855
Hologic Gen-Probe Detection Reagent Kit
Detection reagent used on LEADER instruments for non-APTIMA branded Hologic Gen-Probe Assays.
1,200 tests 201791
AccuProbe Culture Identification Reagent Kit
Reagents for culture identification tests.
100 tests (mycobacterial and fungal) 102800

 

Culture Identification/AccuProbe (Bact)

Description

Quantity

Catalog

AccuProbe GROUP B STREPTOCOCCUS Culture Identification Test
For the identification of Group B Streptococcus (Streptococcus agalactiae) isolated from culture.
20 tests
200 tests
102820
102820B
AccuProbe LISTERIA MONOCYTOGENES Culture Identification Test
For the identification of Listeria monocytogenes isolated from culture.
20 tests 102920
AccuProbe NEISSERIA GONORRHOEAE Culture Identification Test
For the identification of Neisseria gonorrhoeae isolated from culture.
20 tests 102830
AccuProbe STAPHYLOCOCCUS AUREUS Culture Identification Test
For the identification of Staphylococcus aureus isolated from culture.
20 tests 102875
AccuProbe STREPTOCOCCUS PNEUMONIAE Culture Identification Test
For the identification of Streptococcus pneumoniae isolated from culture.
20 tests 102865
Hologic Gen-Probe Detection Reagent Kit
Detection reagent used on LEADER instruments for non-APTIMA branded Hologic Gen-Probe Assays.
1,200 tests 201791
AccuProbe Culture Identification Reagent Kit
Reagents for culture identification tests.
200 tests (bacterial) 102800

 

Culture Identification/AccuProbe (Fungal)

Description

Quantity

Catalog

AccuProbe BLASTOMYCES DERMATITIDIS Culture Identification Test
For the identification of Blastomycesdermatitidis isolated from culture.
20 tests 102890
AccuProbe COCCIDIOIDES IMMITIS Culture Identification Test
For the identification of Coccidioidesimmitis isolated from culture.
20 tests 102895
AccuProbe HISTOPLASMA CAPSULATUM Culture Identification Test
For the identification of Histoplasmacapsulatum isolated from culture.
20 tests 102910
Hologic Gen-Probe Detection Reagent Kit
Detection reagent used on LEADER instruments for non-APTIMA branded Hologic Gen-Probe Assays.
1,200 tests 201791
AccuProbe Culture Identification Reagent Kit
Reagents for culture identification tests.
100 tests (mycobacterial and fungal) 102800

 

Culture Identification/Mycoplasma

Description

Quantity

Catalog

Hologic Gen-Probe Mycoplasma Tissue Culture Non-Isotopic (MTC-NI) Rapid Detection System
DNA probe test for the detection of mycoplasma contamination in tissue culture.
Not intended for diagnostic use.
50 tests 104573
Hologic Gen-Probe Detection Reagent Kit
Detection reagent used on LEADER instruments for non-APTIMA branded Hologic Gen-Probe Assays.
1,200 tests 201791

 

SEXUALLY TRANSMITTED DISEASE

APTIMA COMBO 2, APTIMA CT, APTIMA GC

The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease using the TIGRIS DTS Automated Analyzer or semi-automated instrumentation as specified.

The APTIMA COMBO 2 Assay virtually eliminates inhibition problems and cross-reactivity, offers multiplex detection and differentiation and also improves workflow and throughput. The testing solution is cost-effective by providing two results from one sample and also increases laboratory efficiency with single tube testing. Use of the assay provides clinicians and laboratorians with the appropriate tools to be able to significantly reduce the prevalence and incidence of CT and GC infections in sexually active individuals as well as prevent their serious and costly sequelae.

The sensitivity of the APTIMA COMBO 2 Assay has been shown to be superior to culture and direct specimen tests. The greater sensitivity of the test permits the use of specimens other than endocervical swabs for women and urethral swabs for men. It is the only assay with urine specimen sensitivity equivalent to swab specimen. Additionally, excellent sensitivity and specificity has been demonstrated with vaginal swabs and CytycThinPrep liquid Pap specimens in the APTIMA COMBO 2 Assay. Hologic Gen-Probe also offers single analyte APTIMA assays for individual supplemental testing for CT and GC.

Description

Quantity

Catalog

APTIMA Combo 2 Assay
Target amplification nucleic acid probe test for the qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis and Neisseria gonorrhoeae.
100 tests – for use with DTS 400, DTS 800, and DTS 1600 Systems250 tests – for use with TIGRIS DTS System 301032301130
APTIMA Combo 2 Assay Multi-Pak Kit
Includes 4 x 250 tests APTIMA Combo 2 Assay Reagent Kits.
1,000 tests – for use with TIGRIS DTS System 301130B
APTIMA CT Assay
Target amplification nucleic acid probe test for the qualitative detection and differentiation of ribosomal RNA from Chlamydia trachomatis.
100 tests – for use with DTS 400, DTS 800, and DTS 1600 Systems100 tests (2 x 50) – for use with TIGRIS DTS System250 tests – for use with TIGRIS DTS System 301088302224301199
APTIMA GC Assay
Target amplification nucleic acid probe test for the qualitative detection and differentiation of ribosomal RNA from Neisseria gonorrhoeae.
100 tests – for use with DTS 400, DTS 800, and DTS 1600 Systems100 tests (2 x 50) – for use with TIGRIS DTS System 301091302225
APTIMA CT Assay TIGRIS 100 tests 303091
APTIMA GC Assay TIGRIS 100 tests 303092
APTIMA Controls Kit
APTIMA positive and negative controls for use with APTIMA Combo 2, APTIMA CT, and APTIMA GC Assays.
5 CT + 5 GC controls per box 301110

 

APTIMA HPV Assays

aptima

Cervical cancer is one of the most common female cancers in the world. Human papillomavirus

(HPV) is the etiological agent responsible for more than 99% of all cervical cancers.1-3

The APTIMA HPV assay accurately detects the HPV types likely to progress to cancer.4 In numerous clinical studies involving approximately 45,000 women worldwide, the APTIMA HPV assay has consistently shown similar sensitivity and better specificity than the most frequently used DNA-based test.

Description

Quantity

Catalog

APTIMA HPV Assay, TIGRIS 250 tests 303012
APTIMA HPV Calibrators Kit - 303010
APTIMA HPV Controls Kit - 303011

 

APTIMA Trichomonasvaginalis Assay

A highly sensitive and specific assay for detection of Trichomonasvaginalis. Utilizes proven APTIMA assay technology and TIGRIS system automation. Tests the same samples used for APTIMA Chlamydia trachomatis and Neisseria gonorrhoeae.

Description

Quantity

Catalog

APTIMA Trichomonasvaginalis Assay 250 tests
100 tests
302806
303065
APTIMA Trichomonasvaginalis Controls Kit 302807

 

PACE Systems

Description

Quantity

Catalog

PACE 2C Assay for CHLAMYDIA TRACHOMATIS and NEISSERIA GONORRHOEAE
Single-tube assay to screen for the presence of bothChlamydia trachomatis and Neisseria gonorrhoeae from endocervical and male urethral swab specimens.
100 tests
1,000 tests
103905
103905B
PACE 2 Assay for CHLAMYDIA TRACHOMATIS
For direct detection of Chlamydia trachomatis from endocervical, male urethral, and conjunctival swab specimens.
100 tests
1,000 tests
201792
201792B
PACE 2 Assay for NEISSERIA GONORRHOEAE
For direct detection of Neisseria gonorrhoeae from endocervical and male urethral swab specimens.
100 tests
1,000 tests
201793
201793B
PACE 2 CHLAMYDIA TRACHOMATIS Probe Competition Assay (PCA)
Supplemental test to verify non-specific signal in endocervical and male urethral swab specimens that test positive in the PACE 2 Assays for Chlamydia trachomatis.
20 tests 103548
PACE 2 NEISSERIA GONORRHOEAE Probe Competition Assay (PCA)
Supplemental test to verify non-specific signal in endocervical and male urethral swab specimens that test positive in the PACE 2 Assays for Neisseria gonorrhoeae.
20 tests 103549
Hologic Gen-Probe Detection Reagent Kit
Detection reagent used on LEADER instruments for non-APTIMA branded Hologic Gen-Probe Assays.
1,200 tests 201791
FAST Express Reagent
Improves the handling of excessively viscous specimens in the PACE 2 Assays specimen transport.
200 tests 102930
STD Proficiency Panel
Used as a training aid and to demonstrate the precision of the PACE 2 and APTIMA Combo 2 Assays.
3 vials per box 102325
PACE Specimen Collection Kits for Endocervical Specimens
For collection and transport of endocervical specimens to be used with the PACE 2 Assays.
50 kits per box 103300
PACE Specimen Collection Kits for Urethral or Conjunctival Specimens
For collection and transport of male urethral and conjunctival specimens to be used with the PACE 2 Assays.
50 kits per box 103275
PACE 2 Wash Solution
For use with PACE 2 Assays.
250 mL 102490
PACE 2 Bulk Wash Solution
For use with PACE 2 Assays.
3,800 mL 104171
PACE 2 Reaction Tubes
Polystyrene tubes for use with PACE 2 Assays.
120 tubes per box 102065
Sealing Cards
For use with PACE 2 Assays and APTIMA GPR products.
12 cards per pack 102085

 

ONCOLOGY

PROGENSA PCA3

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second-leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS estimates that about 241,000 Americans were newly diagnosed with prostate cancer in 2011, and that approximately 34,000 men died from the disease.

PCA3 is a gene that is highly over-expressed in prostate cancers. Following a digital rectal examination, the PCA3 gene can be quantified in urine specimens together with the prostate-specific antigen (PSA) gene to generate a PCA3 score. Studies have shown that because the PCA3 gene is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional serum PSA testing in patients who have had one or more previous negative prostate biopsies.

Data from more than 80 peer-reviewed publications suggest that PCA3 gene testing, when used with other patient information, may help address some of the well-known challenges urologists face, such as identifying prostate cancers while reducing unnecessary repeat biopsies.

Hologic Gen-Probe’s PROGENSA PCA3 assay is the first urine-based molecular diagnostic assay to aid in the decision for repeat biopsy. The test has received regulatory approval and is available for sale in the United States, Canada and the European Union.

Cat #

Product

Kit Size

PI

302350 PROGENSA PCA3 Proficiency Panels 16 tests EN
302351 PROGENSA PCA3 Specimen Diluent Kit 14 tests EN
302352 PROGENSA PCA3 Urine Specimen Transport Kit 50 tubes EN
302355 PROGENSA PCA3 Assay Kit 100 tests EN
302355 PROGENSA PCA3 Physician Brochure - L692-MKT
302355 PROGENSA PCA3 Physician Instructions - L693-MKT

PCA3 assay sample collection procedure

PCA3

The Prostate Cancer Gene 3 (PCA3) Assay utilizes whole urine collected following a digital rectal examination (DRE) consisting of three strokes per lobe. The DRE releases prostate cells through the prostate duct system into the urinary tract, where they can be collected in the first catch urine. The urine is processed by addition of Urine Transport Medium (UTM), which lyses the cells and stabilizes the RNA. PCA3 and PSA mRNAs are quantified, and the PCA3 Score is determined based on the ratio of PCA3/PSA mRNA. In addition to normalizing PCA3 signal, measurement of PSA mRNA also serves to confirm that the yield of prostate-specific RNA is sufficient to generate a valid result. Higher PCA3 Scores correlate with higher probability of a positive prostate biopsy.

For further info please visit www.pca3.org