Nichols Institute is at the forefront of the clinical laboratory industry thanks to the combined efforts of our scientific and medical staff and our collaboration with Academic Associates and members of the biotechnology industry.
Because we're the leader in transferring diagnostic innovation from academia and the biotechnology industry, we have often been among the first to bring new assays and technologies to the commercial marketplace.
Assays pioneered by Quest Diagnostics Nichols Institute include:
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ASSAY | |
DATE INTRODUCED | |
CLINICAL APPLICATIONS | |
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| Microalbumin, Intact by HPLC | 2005 | Detect and monitor early renal disease in patients with diabetes mellitus Detect and monitor microalbuminuria in patients with cardiovascular disease Detect kidney damage in individuals at risk for renal disease |
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| ABL Kinase Domain Mutation in CML | 2005 | Detect drug-resistant mutations prior to clinical relapse in patients with chronic myelogenous leukemia Identify individuals suitable for alternative therapy |
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| Yeast D2 LSU rDNA sequencing | 2005 | Rapid, specific identification of yeasts | ||||||||||
| Resistance to Thyroid Hormone Receptor mutation analysis | 2005 | Identify disease-causing mutations in affected individuals Carrier screening in patients with a family history of resistance to thyroid hormone |
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Sarcoma Panel
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2005 | Diagnose various types of sarcoma | ||||||||||
| JAK2 Mutation ( V617 F ) analysis in Plasma | 2005 | Diagnose myeloproliferative disorders | ||||||||||
| c -Kit mutation analysis | 2005 | Diagnose mastocytosis and other hematopoietic malignancies Predict response to therapy |
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| Avian Influenza Virus RNA | 2005 | Diagnose Avian influenza infection | ||||||||||
| Invasive Trophoblast Antigen (ITA) | 2004 | Screen for Down syndrome | ||||||||||
| Fecal Globin (InSure®') | 2004 | Screen for colorectal cancer | ||||||||||
| TA-90 | 2004 | Malignant melanoma management | ||||||||||
| Mitochondrial DNA | 2004 | Assess antiviral drug toxicity in patients with HIV | ||||||||||
| Vasopressin (AVP) Mutation Analysis | 2004 | Differential diagnosis of diabetes insipidus | ||||||||||
| Vasopressin Receptor 2 (AVPR2) Mutation Analysis | 2004 | Differential diagnosis of diabetes insipidus | ||||||||||
| Aquaporin 2 (AQP2) Mutation Analysis | 2004 | Differential diagnosis of diabetes insipidus | ||||||||||
| CD20, CD25, CD33, CD52, and CD117 (flow cytometry) | 2003 | Predict sensitivity to specific cancer therapies | ||||||||||
| Serotonin Release Assay (SRA) | 2003 | Diagnose heparin-induced thrombocytopenia (HIT) type II | ||||||||||
| 21-Hydroxylase Deficiency Mutation Analysis | 2003 | Diagnosis and genetic counseling | ||||||||||
| Pro-BNP | 2003 | Risk assessment and diagnosis of cardiac disorders | ||||||||||
| Plasminogen Activator Inhibitor-1 (PAI-1) 4G/5G Polymorphism | 2003 | Assess risk of thrombosis | ||||||||||
| Niemann-Pick Disease Mutation Analysis | 2002 | Diagnosis and genetic counseling | ||||||||||
| Myeloid Disorders Profile, FISH | 2002 | Detect common chromosomal abnormalities found in myelodysplastic syndromes, myeloproliferative disorders, and acute myelogenous leukemia | ||||||||||
| Familial Dysautonomia Mutation Analysis | 2002 | Diagnosis and genetic counseling | ||||||||||
| Kennedy Disease Mutation Analysis | 2002 | Diagnosis and genetic counseling | ||||||||||
| Cystic Fibrosis Complete (CF Complete™, gene sequencing) | 2002 | Diagnosis and genetic counseling | ||||||||||
| Angiotensin II Type 1 Receptor Polymorphism Analysis | 2002 | Assess risk of cardiovascular disease | ||||||||||
| Cyclic Citrullinated Peptide IgG | 2002 | Diagnose rheumatoid arthritis | ||||||||||
| 6-Sulfatoxymelatonin | 2002 | Monitor melatonin therapy | ||||||||||
| Cystatin C | 2002 | Assess renal function | ||||||||||
| Twin Zygosity | 2002 | Distinguish between fraternal and identical twins prior to prenatal medical intervention | ||||||||||
| Genetic Identity (Human) | 2002 | Genetically identify individuals or their clinical specimens | ||||||||||
| HBV Genotype | 2002 | Therapeutic management of hepatitis B infection | ||||||||||
| Cytochrome P450 2D6 Genotype | 2002 | Determine risk of drug toxicity or poor therapeutic response | ||||||||||
| Nijmegan Assay | 2002 | Manage hemophilia therapy | ||||||||||
| ImmunoCyt™' Bladder Cancer Test | 2002 | Diagnose bladder cancer | ||||||||||
| Microvascular Density | 2002 | Potential marker for selecting and monitoring cancer therapy | ||||||||||
| Dermatan Sulfate | 2002 | Potential marker for monitoring anti-thrombotic therapy | ||||||||||
| Bladder Cancer, FISH | 2001 | Detect bladder cancer recurrence | ||||||||||
| TIGR Gene Mutation Analysis (OcuGene™') | 2001 | Determine severity and optimize treatment of glaucoma | ||||||||||
| Prekallikrein (Fletcher Factor) Activity | 2001 | Differential diagnosis in patients with prolonged PTT | ||||||||||
| Matrix Metaloproteinase-3 (MMP-3) | 2001 | Inflammatory tissue marker | ||||||||||
| Borrelia burgdorferi, Urine (real-time PCR technology) | 2001 | Diagnose acute Lyme disease (highly sensitive method; ease of sample collection [urine]) | ||||||||||
| Heptimax™ (HCV viral load assay) | 2001 | Manage hepatitis C infection (broad reporting range) | ||||||||||
| PTH, Biointact (Amino Acids 1-84) | 2001 | Diagnose or monitor parathyroid disorders | ||||||||||
| bcr/abl Gene Rearrangement (real-time PCR technology) | 2001 | Diagnose and manage chronic myelogenous leukemia (CML) | ||||||||||
| Bile Acids (LC/MS/MS) | 2001 | Diagnose and manage various liver diseases | ||||||||||
| Thyroglobulin ratio (ICMA / RIA) | 2001 | Management of thyroid cancer | ||||||||||
| HCV RNA (TMA technology for viral load determination) | 2001 | Manage hepatitis C infection (ultrasensitive assay) | ||||||||||
| bcl-2 Gene Translocation (mbr) | 2001 | Diagnosis, prognosis, and management of B-cell lymphoma | ||||||||||
| bcl-2 Gene Translocation (mcr) | 2001 | Diagnosis, prognosis, and management of B-cell lymphoma | ||||||||||
| Anaplastic Lymphokinase, ALK | 2001 | Diagnose anaplastic large cell lymphoma (ALCL) | ||||||||||
| Blastomere Screen, FISH | 2000 | Identification of embryonal cell abnormalities | ||||||||||
| Brain Natriuretic Peptide (BNP) | 2000 | Risk assessment and diagnosis of cardiac disorders | ||||||||||
| HCV RNA Genotype (DupliType™) | 2000 | Therapeutic management of hepatitis C infection | ||||||||||
| Cytochrome P450 2C19 Genotype | 2000 | Determine risk of drug toxicity or poor therapeutic response | ||||||||||
| Sirolimus (Rapamycin) | 2000 | Monitor immunosuppressive therapy following organ transplant | ||||||||||
| HCV RNA, 3rd Generation bDNA | 2000 | Manage hepatitis C infection (broad range assay) | ||||||||||
| HCV RNA, Qualitative TMA | 2000 | Manage hepatitis C infection (ultrasensitive assay) | ||||||||||
| Acid Labile Subunit (ALS) | 1999 | Growth disorder management | ||||||||||
| Chromosome Rearrangement, SKY | 1999 | Facilitate patient management by identifying marker and rearranged chromosomes | ||||||||||
| Growth Hormone (ligand mediated immuno-functional assay) | 1999 | Diagnose and monitor growth disorders | ||||||||||
| N-Telopeptide (serum) | 1999 | Management of bone disorders | ||||||||||
| HIV-1 RNA, 3rd Generation bDNA | 1998 | Therapeutic management of HIV-1 infection | ||||||||||
| LDL Cholesterol Subparticles | 1998 | Risk assessment and management of cardiac disease | ||||||||||
| Cytochrome P450 2D6 Genotype | 1998 | Obtain improved safety and efficacy data from clinical trials; avoid adverse drug responses in clinical trial participants | ||||||||||
| Cytokeratin, IHC | 1998 | Epithelial cell marker | ||||||||||
| Methylenetetrahydrofolate Reductase (MTHFR) DNA Mutation Analysis | 1998 | Assess risk of familial cardiac disease | ||||||||||
| 21-Hydroxylase Antibody | 1998 | Diagnose autoimmune polyglandular syndrome (APS) and Addison's disease | ||||||||||
| RAR-alpha t(15;17) Translocation | 1997 | Diagnose and manage acute promyelocytic leukemia (APL) | ||||||||||
| HER-2 (FISH) | 1997 | Breast cancer management | ||||||||||
| RET Proto-oncogene Mutations | 1997 | Diagnose multiple endocrine neoplasia (MEN) and medullary thyroid cancer (MTC) | ||||||||||
| Islet Cell Antigen 512 (ICA 512) Antibody | 1996 | Assess risk and diagnose type I diabetes | ||||||||||
| HIV-1 RNA, bDNA | 1996 | Therapeutic management of HIV-1 infection | ||||||||||
| HCV RNA, bDNA | 1996 | Manage hepatitis C infection | ||||||||||
| CKR -5 Mutation | 1996 | Assess predisposition to HIV infection | ||||||||||
| Collagen Crosslinks N-Telopeptide, Urine | 1993 | Management of bone disorders | ||||||||||
| Prorenin | 1993 | Predict nephropathy and retinopathy in diabetic patients | ||||||||||
| Prostate Specific Antigen (PSA), Ultrasensitive | 1993 | Detect prostate cancer recurrence following prostatectomy | ||||||||||
| Direct Renin, IRMA | 1993 | Differential diagnosis of hypertension | ||||||||||
| Vitamin C | 1993 | Diagnose/monitor deficiency (scurvy) | ||||||||||
| Growth Hormone Binding Protein | 1992 | Diagnose and monitor growth disorders | ||||||||||
| Growth Hormone Releasing Hormone (GHRH) | 1992 | Differential diagnosis of acromegaly | ||||||||||
| IGF Binding Protein-2 (IGFBP-2) | 1992 | Potential tumor marker | ||||||||||
| Thyrotropin Releasing Hormone (TRH) | 1992 | Diagnose ectopic tumors | ||||||||||
| Thyroid Peroxidase Antibody | 1991 | Diagnose autoimmune thyroid disease | ||||||||||
| Corticotropin Releasing Hormone (CRH) | 1991 | Differential diagnosis of Cushing syndrome | ||||||||||
| IGF Binding Protein-3 (IGFBP-3) | 1991 | Differential diagnosis of growth disorders | ||||||||||
| Insulin Receptor Antibody | 1991 | Type II diabetes marker (insulin resistance) | ||||||||||
| Procollagen Peptide - Type 1 | 1991 | Marker of bone formation in patients with renal disease | ||||||||||
| Pyridinium Crosslinks, HPLC | 1991 | Management of bone disorders | ||||||||||
| Bone-Specific Alkaline Phosphatase | 1991 | Therapeutic monitoring of osteoporosis and Paget's disease | ||||||||||
| Free Cortisol, Serum | 1990 | Differential diagnosis of adrenal function disorders | ||||||||||
| Epidermal Growth Factor Receptor | 1989 | Breast cancer prognostic marker | ||||||||||
| Free T4, Direct Dialysis | 1988 | Differential diagnosis of thyroid disorders (most accurate method for free T4) | ||||||||||
| IGF Binding Protein-1 (IGFBP-1) | 1988 | Monitor insulin response; insulinoma marker | ||||||||||
| PTH, Intact (IRMA) | 1988 | Diagnose or monitor parathyroid disorders | ||||||||||
| PTH Related Protein (PTH-RP) | 1988 | Differential diagnosis of hypercalcemia; management of hypercalcemia or cancer | ||||||||||
| Testosterone, Free (dialysis method) | 1988 | Assessment of androgen status | ||||||||||
| 18-Hydroxycorticosterone | 1987 | Diagnosis of adrenal adenoma | ||||||||||
| Atrial Natriuretic Hormone (ANH) | 1986 | Assess water and sodium imbalance | ||||||||||
| Insulin-Like Growth Factor II (IGF-II) | 1986 | Diagnose non-islet-cell tumor hypoglycemia | ||||||||||
| Collagen Stimulating Immunoglobulin (CSI) | 1986 | Graves' disease diagnosis | ||||||||||
| Thyroid Growth Stimulating Immunoglobulin (TGI) | 1986 | Graves' disease diagnosis | ||||||||||
| T3 Antibody | 1985 | Evaluation of discordant T3 levels | ||||||||||
| T4 Antibody | 1985 | Evaluation of discordant T4 levels | ||||||||||
| TSH Antibody | 1985 | Evaluation of discordant TSH levels | ||||||||||
| Cathepsin D | 1985 | Breast cancer prognostic marker | ||||||||||
| Free Cortisol, Urine | 1985 | Differential diagnosis of adrenal function disorders | ||||||||||
| Thyroid Stimulating Immunoglobulin (TSI) | 1984 | Diagnose and manage Graves' disease | ||||||||||
| Thyroid Binding Inhibitory Immunoglobulin (TBII) | 1984 | Diagnose and manage Graves' disease, neonatal hypothyroidism, and postpartum thyroid dysfunction | ||||||||||
| PTH, Intact | 1983 | Diagnose or monitor parathyroid disorders | ||||||||||
| 3a-Androstanediol Glucuronide | 1983 | Diagnose hirsutism | ||||||||||
| Beta-Endorphin/Lipotropin | 1983 | Diagnose Cushing syndrome and pituitary tumors | ||||||||||
| Free Insulin | 1983 | Management of insulin-dependent diabetes | ||||||||||
| Catecholamines (plasma RIA) | 1982 | Diagnosis of pheochromocytoma | ||||||||||
| PTH (N-Terminal) | 1981 | Diagnose or monitor parathyroid disorders | ||||||||||
| Somatomedin C (Insulin-like growth factor-I [IGF-1]), Dried Blood (Somato Screen) | 1981 | Diagnose growth disorders and assess nutritional status | ||||||||||
| Vitamin D (1,25-Dihydroxy) | 1981 | Differential diagnosis of hypocalcemia; monitor renal disorders | ||||||||||
| Antiglomerular Basement Membrane | 1980 | Diagnosis of Goodpasture syndrome | ||||||||||
| Thyroglobulin | 1980 | Monitor thyroid carcinoma | ||||||||||
| Vasoactive Intestinal Polypeptide (VIP) | 1980 | Diagnose watery diarrhea syndrome and multiple endocrine neoplasia (MEN) | ||||||||||
| Free Testosterone | 1979 | Diagnose androgen-related disorders when total testosterone seems inappropriately low | ||||||||||
| Oxytocin | 1979 | Parturition hormone | ||||||||||
| Pepsinogen I | 1979 | Diagnose and manage duodenal ulcer | ||||||||||
| Somatomedin C (Insulin-like growth factor-I [IGF-1]), Plasma | 1979 | Diagnose growth disorders and assess nutritional status | ||||||||||
| Androstenedione | 1977 | Diagnose androgen-related disorders | ||||||||||
| Estriol | 1977 | Monitor high risk pregnancies | ||||||||||
| Progesterone Receptor | 1977 | Breast cancer management | ||||||||||
| Antidiuretic Hormone (ADH, arginine vasopressin, AVP) | 1976 | Diagnose water metabolism disorders | ||||||||||
| Antimicrosomal Antibody | 1976 | Differential diagnosis of autoimmune thyroid disease | ||||||||||
| Thyroglobulin Antibody | 1976 | Diagnose and manage autoimmune thyroid disease | ||||||||||
| Cortisol, Free (RIA) | 1976 | Differential diagnosis of adrenal function disorders | ||||||||||
| Glucagon | 1976 | Diagnose glucagonoma and glucagon deficiency in hypoglycemic patients | ||||||||||
| Reverse Triiodothyronine | 1976 | Evaluate euthyroid sick patients with low T3 | ||||||||||
| Estrogen Receptor | 1975 | Breast cancer management | ||||||||||
| Prolactin | 1975 | Diagnose and manage pituitary adenoma; differential diagnosis of hypogonadism | ||||||||||
| Vitamin D (25-Hydroxy) | 1975 | Diagnose intestinal malabsorption, vitamin D deficiency or intoxication | ||||||||||
| Calcitonin | 1974 | Diagnose and monitor medullary thyroid carcinoma (MTC) | ||||||||||
| PTH (C-Terminal) | 1974 | Diagnose or monitor parathyroid disorders | ||||||||||
| Plasma Renin Activity | 1973 | Differential diagnosis of hypertension | ||||||||||
| 11-Deoxycortisol | 1972 | Diagnose congenital adrenal hyperplasia (CAH) caused by 11b-hydroxylase deficiency | ||||||||||
| Thyroxine Binding Globulin | 1972 | Differential diagnosis of thyroid disorders | ||||||||||
| Aldosterone (RIA) | 1971 | Diagnose primary hyperaldosteronism | ||||||||||
| Follicle Stimulating Hormone | 1971 | Diagnose disorders of gonadal function | ||||||||||
| Luteinizing Hormone | 1971 | Diagnose disorders of gonadal function | ||||||||||
| Thyroid Stimulating Hormone | 1971 | Diagnose hypothyroidism | ||||||||||
| Thyroxine (Total and Free) | 1971 | Diagnose thyroid disorders | ||||||||||
| Triiodothyronine (Total and Free) | 1971 | Diagnose thyroid disorders | ||||||||||
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