Molecular Diagnostics

Genesis Laboratory Management, LLC (Genesis Lab) Panels and Targets

The Genesis Lab Diarrhea Pathogen Panel uses polymerase chain reaction (PCR) technology to test for twenty-two gastroenteritis-associated pathogens. A single sample and a single test provide unparalleled clinical certainty and patient care. As a result, the Genesis Lab Expanded GI Panel provides targeted therapies that do the following:
  • Reduce the duration of hospital stays (1)
  • Reduce costly and invasive downstream testing (CT scans, X-rays, and ultrasounds) (1)
  • Reduce time from sample collection and resulting to appropriate antimicrobial therapy (2)
 

Genesis Lab Expanded Diarrhea Pathogen Panel Targets
General Enteric Bacterial Targets
  • Campylobacter (jejuni, coli, and upsaliensis)
  • Clostridium difficile (Toxin A/B) / positive reflex to active toxin detection assay*
  • Plesiomonas shigelloides
  • Salmonella
  • Vibrio (parahaemolyticus, vulnificus, and cholerae)
  • Vibrio cholerae
  • Yersinia enterocolitica
Diarrheagenic E. coli/Shigella Targets
  • Enteroaggregative E. coli (EAEC)
  • Enteropathogenic E. coli (EPEC)
  • Enterotoxigenic E. coli (ETEC)
  • Shiga-like toxin-producing E. coli (STEC) / additional O157 serotyping
  • Shigella/Enteroinvasive E. coli (EIEC)

Parasitic Targets
  • Cryptosporidium
  • Cyclospora cayetanensis
  • Entamoeba histolytica
  • Giardia lamblia
Viral Targets
  • Adenovirus F 40/41
  • Astrovirus
  • Norovirus GI/GII
  • Rotavirus A
  • Sapovirus (I, II, IV, and V)

* The detection of toxigenic Clostridium difficile (for toxins A/B) on the Genesis Lab Diarrhea Pathogen Panel indicates the presence of genes that encode for enterotoxin A/B but not the toxins themselves. Therefore, the detection of toxigenic Clostridium difficile without the presence of the toxins (A/B) could suggest a carrier state with no active toxin production. Detection of both toxigenic Clostridium difficile and the active toxin would be consistent with Clostridium difficile illness (CDI) if clinically suspected. Genesis Lab reflexes all detected toxigenic Clostridium difficile results to a second EIA-based assay which reports the presence or absence of the actively secreted toxins, A and B. A multi-step algorithm for diagnosis of CDI which encompasses detection of the bacterium, the toxin, and the presence of inflammation (ie. calprotectin or lactoferrin) is currently recommended by many experts for definite CDI diagnosis and differentiation from carrier states. References:
  1. 1. Beal S., Tremblay E., Toffel S., Velez L., Rand K. A gastronintestinal PCR panel improves clinical management and lowers healthcare costs. American Association for Clinical Chemistry, August 2017.
  2. 2. Cybulski R, Bateman A, Bourassa L, Bryan A, Beail B, Matsumoto J, Cookson B, Fang FC; Clinical impact of a Multiplex Gastrointestinal PCR Panel in Patients with Acute Gastroenteritis. 2018. Clinical Infectious Diseases, ciy357, https://doi.org/10.1093/cid/ciy357.
The Genesis Lab Syndromic Diarrhea Pathogen Panel uses polymerase chain reaction (PCR) technology to test for up to twenty gastroenteritis-associated pathogens in five clinically relevant categorizations. A single sample allows the physician to order testing under the following categorizations: Enterics, Extended Enterics, Parasites, Enteric Virals, C. Diff, or any combination of the five individual batteries. This algorithmic approach provides the same unparalleled clinical certainty and patient care as the Genesis Lab Expanded Diarrhea Pathogen Panel, but allows the care provider to narrow the series of tests based on patient history, clinical expertise, complimentary testing methodologies, etc.

Genesis Lab Syndromic Diarrhea Pathogen Panel Targets

Targeted Enteric Bacterial Panel
  • Campylobacter (jejuni, coli, and upsaliensis)
  • Salmonella
  • Shiga-like toxin-producing E. coli (STEC) / additional O157 serotyping
  • Shigella/Enteroinvasive E. coli (EIEC)
Targeted Extended Enteric Bacterial Panel
  • Vibrio (parahaemolyticus, vulnificus, and cholerae)
  • Vibrio cholerae
  • Yersinia enterocolitica
  • Enterotoxigenic E. coli (ETEC)
  • Plesiomonas shigelloides

Targeted Enteric Parasite Panel
  • Cryptosporidium
  • Entamoeba histolytica
  • Giardia lamblia
Targeted Enteric Viral Panel
  • Adenovirus F 40/41
  • Astrovirus
  • Norovirus GI/GII
  • Rotavirus A
  • Sapovirus (I, II, IV, and V)

Targeted Enteric Parasite Panel
Clostridium difficile (Toxin A/B) / positive reflex to active toxin detection assay*

*The detection of toxigenic Clostridium difficile (for toxins A/B) on the Genesis Lab Diarrhea Pathogen Panel indicates the presence of genes that encode for enterotoxin A/B but not the toxins themselves. Therefore, the detection of toxigenic Clostridium difficile without the presence of the toxins (A/B) could suggest a carrier state with no active toxin production. Detection of both toxigenic Clostridium difficile and the active toxin would be consistent with Clostridium difficile illness (CDI) if clinically suspected. Genesis Lab reflexes all detected toxigenic Clostridium difficile results to a second EIA-based assay which reports the presence or absence of the actively secreted toxins, A and B. A multistep algorithm for diagnosis of CDI which encompasses detection of the bacterium, the toxin, and the presence of inflammation (ie. calprotectin or lactoferrin) is currently recommended by many experts for definite CDI diagnosis and differentiation from carrier states.
The Genesis Lab Respiratory (RP) Panel uses polymerase chain reaction (PCR) technology to test for twenty-one (21) commonly associated respiratory pathogens. The Genesis Lab Respiratory (RP) Panel delivers the rapid, targeted, clinical results that drive the most accurate diagnoses and therapies for patients. Multiplexed respiratory panel results have been shown to significantly reduce ICU days (1) and the duration of antibiotic use (2). Additionally, the increased certainty of viral diagnoses also ensures adherence to current antibiotic stewardship directives, reducing the likelihood of antibiotic resistance and patient morbidity (3). The Genesis Lab Respiratory (RP) Panel optimizes patient management with clinically actionable results and measurably improves patient outcomes.

Bacterial Targets
  • Bordetella pertussis
  • Bordetella parapertussis
  • Chlamydophila pneumoniae
  • Mycoplasma pneumoniae
Viral Targets
  • Adenovirus
  • Coronavirus HKU1
  • Coronavirus NL63
  • Coronavirus 229E
  • Coronavirus OC43
  • Human Metapneumovirus
  • Human Rhinovirus/Enterovirus
  • Influenza A
  • Influenza A/H1
  • Influenza A/H1-2009
  • Influenza A/H3
  • Influenza B
  • Parainfluenza 1
  • Parainfluenza 2
  • Parainfluenza 3
  • Parainfluenza 4
  • Respiratory Syncytial Virus

 
 

The Genesis Lab Streptococcus Group A (Streptococcus pyogenes) Molecular Test is a singleplexed, isothermal nucleic acid amplification assay for the detection of group A beta-hemolytic Streptococcus pyogenes. Streptococcus group A contributes to 20 percent of infections of tonsillitis, pharyngitis, and scarlet fever and causes impetigo (pyoderma) (1). It is typical of young children with prevalence in schools, nursing homes, and hospitals as well (2),(3). The Genesis Lab Streptococcus Group A (Streptococcus pyogenes) Molecular Test both replaces low sensitivity Group A Streptococcus (GAS) rapid antigen detection tests and provides the recommended and needed backup testing to pediatric antigen results. The complications associated with Streptococcus Group A in the pediatric community make the Genesis Lab Streptococcus Group A Molecular Test a perfect frontline and confirmatory physician aid.

The Genesis Lab Urinary Tract Microbiota (UTM) Molecular Test uses the most advanced nanoscale multiplexed polymerase chain reaction (PCR) technology to test for seventeen commonly associated urinary tract pathogens. Urinary tract infections (UTI’s) are the leading cause of morbidity and health care expenditures across a myriad of demographics. The Genesis Lab UTM Molecular Test arms the physician with definitive organisms’ identifications. Due to high recurrence rates and increasing antimicrobial resistance among uropathogens, Genesis Lab UTM Molecular Test positives are reflexed to class specific, phenotype-based culture and sensitivity panels. The three panels subject non-fastidious Gram-negative isolates, non-fastidious Gram-positive isolates, and fungal isolates (Candida albicans) to class appropriate antibiotic antifungal dilutions and provide minimum inhibitory concentrations (MICs) to guide antibiotic stewardship directed eradication.

Gram-negative Bacterial Targets
  • Escherichia coli
  • Klebsiella pneumoniae
  • Proteus mirabilis
  • Pseudomonas aeruginosa
  • Providencia stuartii
  • Morganella morganii
  • Klebsiella oxytoca
  • Enterobacter cloacae
  • Citrobacter freundii
  • Enterobacter aerogenes
  • Acinetobacter baumannii
  • Proteus vulgaris

Gram-positive Bacterial Targets
  • Enterococcus faecalis
  • Streptococcus agalactiae (Group B Strep)
  • Staphylococcus saprophyticus
  • Enterococcus faecium

Gram-Negative Panel
  • Amikacin
  • Ampicillin
  • Ampicillin/Sulbactam
  • Aztreonam
  • Cefazolin
  • Cefepime
  • Ceftazidime
  • Ceftazidime/Avibactam
  • Ceftolozane/Tazobactam4
  • Ceftriaxone
  • Ciprofloxacin
  • Doripenem
  • Ertapenem
  • Gentamicin
  • Imipenem
  • Levofloxacin
  • Meropenem
  • Minocycline
  • Nitrofurantoin
  • Piperacillin/Tazobactam
  • Tetracycline
  • Tigecycline
  • Tobramycin
  • Trimethoprim/Sulfa-methoxazole

Gram-Positive Panel
  • Ampicillin
  • Ceftaroline
  • Ceftriaxone
  • Chloramphenicol
  • Ciprofloxacin
  • Clindamycin
  • Daptomycin
  • DTest1*
  • DTest2*
  • Erythromycin
  • Gentamicin
  • Gentamicin 500µg/mL
  • Levofloxacin
  • Moxifloxacin
  • Nitrofurantoin
  • Oxacillin + 2% Nacl
  • Penicillin
  • Rifampin
  • Streptomycin 1000µg/mL
  • Telavancin
  • Tetracycline
  • Tigecycline
  • Trimethoprim / Sulfamethoxazole
  • Vancomycin

Fungal Targets
  • Candida albicans
  • Reflex UTM positives to Genesis Lab offers Screening via the Sensititre ARIS 2X ID/AST System.

Fungal (C. albicans) panel
  • Voriconazole
  • 5-Flucytosine
  • Fluconazole
  • Caspofungin
  • Itraconazole
  • Micafungin

The Genesis Lab Women’s Health (WH) Molecular Test uses the most advanced nanoscale multiplexed polymerase chain reaction (PCR) technology to test for nine common sexually transmitted pathogens, four healthy vaginal constituents, and eleven bacterial vaginosis associated flora, four aerobic vaginitis flora, and seven Candidiasis-related Candida spp. The human vaginal environment is highly dependent upon community-based consortia equilibria and traditional methods (culture and microscopy) are subjective and lacking in sensitivity and specificity (1). Other on-market molecular methods suffer from limited flora coverage and throughput capacity (2). The Genesis Lab Women’s Health (WH) Molecular Test better categorizes and profiles the existing flora giving the physician unparalleled surveillance capabilities.

Sexually Transmitted Infection (STI) Targets
  • Chlamydia trachomatis
  • Neisseria gonorrhoeae
  • Trichomonas vaginalis
  • Herpes simplex virus 1
  • Herpes simplex virus 2
  • Mycoplasma genitalium
  • Haemophilus ducreyi
  • Treponema pallidum
  • Ureaplasma urealyticum
Lactobacilli panel
(L.crispatus, L. gasseri, and L. jensenii alone, or as consortium colonizers, predominate the flora in healthy vaginal microbiomes. It is also common for vaginal flora to contain L. iners. It is important to note that L. iners may be present in both normal and transitional vaginal environments.)
  • Lactobacillus crispatus
  • Lactobacillus gasseri
  • Lactobacillus iners
  • Lactobacillus jensenii
Aerobic Vaginitis
Aerobic vaginitis (AV) is characterized by the alteration of healthy Lactobacillus species levels in the presence of common aerobic enteric bacteria. Symptoms may include discharge, elevated pH, burning, stinging and dyspareunia. AV is associated with increased risk of preterm birth, sexually transmitted infections (STIs) and abnormal pap test results.
  • Staphylococcus aureus
  • Streptococcus agalactiae (Group B Strep)
  • Enterococcus faecalis
  • Escherichia coli
Bacterial Vaginosis Panel
(Bacterial vaginosis (BV) is characterized by the replacement of Lactobacilli species with anerobic flora. Presence of anaerobic flora and depletion of Lactobacilli species suggests abnormal population dynamics within the vaginal environment. BV is associated with the increased risk of pre term birth, sexually transmitted infections (STIs), and pelvic inflammatory disease (PID).)
  • Atopobium vaginae
  • Bacterioides fragilis
  • BVAB2
  • Gardnerella vaginalis
  • Prevotella bivia
  • Megaspherea 1
  • Megaspherea 2
  • Mobiluncus mulieris
  • Mobiluncus curtisii
  • Mycoplasma hominis
  • Ureaplasma urealyticum
Candidiasis Complete Panel
Candidiasis is a fungal infection caused by Candida species overgrowth. While Candida species do exist as normal constituents of human microflora, overcolonization can lead to infection. A common example of this overcolonization state is observed in Vulvovaginitis (common vaginal yeast infection).
  • Candida albicans
  • Candida dublinesis
  • Candida glabrata
  • Candida krusei
  • Candida lusitaniae
  • Candida parapsilosis
  • Candida tropicalis

The Genesis Nail Fungal (NF) Panel uses the most advanced nanoscale multiplexed polymerase chain reaction (PCR) technology to test for twenty-eight fungal targets and one arachnid target (scabies). This precision of the Genesis NF Panel allows for:
  • Alternative antifungal therapies where the risk of hepatoxicity exits / Lamisil (Terbinafine) treatment courses(1)
  • Targeted therapies such as systemic Itraconazole therapy for Aspergillus spp. Related onychomycosis(2)
  • Ruling out a large fungal consortium as the cause of abnormal nail appearance
  • The confirmation insurance companies require in order to subsidize antifungal medication(s)
 
Targeted Enteric Bacterial Panel
  • Campylobacter (jejuni, coli, and upsaliensis)
  • Salmonella
  • Shiga-like toxin-producing E. coli (STEC) / additional O157 serotyping
  • Shigella/Enteroinvasive E. coli (EIEC)