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:

		ASSAY		DATE INTRODUCED		CLINICAL APPLICATIONS
		Chickungunya virus by PCR		2008		Sensitive method for diagnosing chickungunya virus infection
		Aspirin Resistance (11-Dehydro Thromboxane B2)		2008		Identification of individuals who have resistence to aspirin therapy
		HE4		2008		Assist in evaluation of ovarian tumors and monitor disease progression in patients with epithelial ovarian cancer
		1,25-Dihydroxy Vitamin D, LC/ MS/MS		2008		Differential diagnosis of vitamin D-dependent rickets (type I vs type II); monior vitamin D therapy in patients with chronic renal disease
		Proteasome Activity		2007		Detecting elevated level of proteasome activity in numerous hematological malignancies
		Lipoprotein Fractionation by Ion Mobility		2007		Ion mobility offers the only direct measurement of lipoprotein particle size and concentration for each lipoprotein from HDL3 to large VLDL; used to assess cardiovascular disease risk
		Estrone, LC/MS/MS		2007		Assess estrogen status in postmenopausl women; assess placental estrogen production
		Estradiol, LC/MS/MS		2007		Assess ovarian function in patients with menstrual disorders, precocious or delayed puberty, and menopause; assess gynecomastia in men
		Pregnenolone, LC/MS/MS		2007		Diagnose 3beta-hydroxysteroid dehydrogenase deficiency; diagnose adrenal virilizing tumors
		Vitamin B6, LC/MS/MS		2007		Diagnose vitamin B6 deficiency or overdosage
		Fragile X Carrier Screening [rapid through-put analysis]		2007		Detect fragile X syndrome (FXS) carriers; determine individual's risk of having a child with FXS; diagnose FXS postnatally; method is taylored for high through-put screening
		Genomics Alterations, Postnatal ClariSure™ CGH		2007		Adjunct test for the study of patients with unexplained mental retardation and/or developmental delay
		CYP450 2C9 and VKORC1		2007		Predict patient-specific warfarin response; assist in determining initial warfarin dosage
		von Willebrand Disease (vWD)Mutation Analysis		2007		Differentiate mild hemophilia A from type 2N vWD; distinguish type 2A from type 2B vWD
		CellSearch® Circulating Tumor Cells, Breast Cancer		2007		Predict progression-free survival and overall survival in patients with metastatic breast cancer
		Liver Fibrosis Panel, HepaScore™		2007		Assist with the non-invasive diagnosis and staging of liver fibrosis in patients with hepatitis C
		Breast Cancer Gene Expression Ratio (H/I)		2007		Predict risk of breast cancer recurrence
		ABL T3151 Mutation in CML, Plasma-based, Leumeta™		2007		Predict resistance to imatinib therapy in patients with CML
		CAH (21 Hydroxylase Deficiency) Mutations		2007		Confirm diagnosis of 21-Hydroxylase deficiency (21-OHD); screen for 21-OHD carrier status in at-risk individuals; prenatal diagnosis of 21-OHD
		Chagas Disease, RIPA		2007		Assist in confirmation of T cruzi infection
		HLA B*5701 Typing		2007		Predict hypersensitivity reaction to abacavir therapy
		BCR /Abl T315I Mutation		2006		Early detection of T315I mutation of CML patient in therapy or pre-therapy could allow alternative treatment
		Jak2 Exon 12 Mutations		2006		Diagnosis of polycythemia vera and idiopathic erythrocytosis
		RAS Mutation Analysis		2006		RAS gene mutations are associated with pancreatic cancer (80-90%+D13), colorectal cancer (30-60%), non-melanoma skin cancer (30-50%), and hematopoietic neoplasias of myeloid origin (18-30%). Patients with colon cancer and KRAS mutation do not respond to anti-EDGR antibodies-based therapy.
		Soluble Myeloperoxidase by Flow		2006		Useful in the diagnosis of various tumors. It is also useful in the prognosis of cardiac vascular disorders.
		Bcr-Abl Gene Rearrangement		2006		Gene rearrangement in Cancer
		B Cell Gene Rearrangement		2006		Establish clonality of B-cell gene rearrangements for the diagnosis of B-cell neoplasms and for identifying minimal residual disease or early recurrence in those patients with previous diagnosis of B-cell neoplasm
		T Cell Receptor (TCR) Gene Rearrangement		2006		Establish clonality of T-cell receptor gene rearrangement for the diagnosis of T-cell lymphoid neoplasms and indentification of minimal residual disease or early recurrence in patients with previous diagnosis of T-cell neoplasm
		Lp-PLA2 Activity Assay (Calorimetric)		2006		Assess risk of coronary heart disease and stroke
		EGFR Mutation Analysis (TK Domain)		2006		Select patients who are most likely to respond to targeted lung cancer therapy, including iressa and tarceva
		Cancer of Unknown primary ( CUP )		2005		Identification of the source of a primary tumor, presenting as metastatic carcinoma from an unknown primary site
		Hyperglycosylated hCG ( ITA )		2005		Marker for early diagnosis of pregnancy and Down syndrome screening
		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
		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
		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
		Sarcoma Panel • Ewings Sarcoma t 11:22 and t 21:22 • Rhabdomyosarcoma mutation analysis ( Alveolar PAX3/FKHR,PAX7/FKHR) • Sarcoma Mutation analysis (Synovial,SYT-SSX1,SYT-SSX2)		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
		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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