NGeneBio - BRCAaccuTest™ & BRCAaccuTest™ PLUS

This is an NGS-based precision diagnostic panel that can perform BRCA1/2 genetic testing of hereditary breast and ovarian cancer patients.

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Description
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NGS-based breast/ovarian cancer genome analysis precision diagnosis

BRCAaccuTest™ PLUS helps early diagnosis and optimal treatment through the NGS-based precise examination of BRCA gene variations that may cause breast cancer or ovarian cancer.

* Cancer types to which BRCAaccuTest™ PLUS is applicable Breast cancer/ovarian cancer

Korea’s first product certified by Korea Ministry of Food and Drug Safety and CE-IVD

It is the first in Korea to be approved as a grade 3 in vitro diagnostic medical device by Korea Ministry of Food and Drug Safety and CE-IVD certified for the first time in Asia, ensuring safety.

BRCAaccuTest™ · CE-IVD certification: June 2016 · Licensed by Korea Ministry of Food and Drug Safety: December 2017

BRCAaccuTest™ PLUS · CE-IVD certification: February 2018 · Licensed by Korea Ministry of Food and Drug Safety: August 2021

Combination with genome big data automatic analysis software

BRCAaccuTest™ PLUS may be used in combination with ‘NGeneAnalySys’ which is a genome big data auto analysis software program. NGS data produced from test reagents are applied to the bioinformatics pipeline, and all the steps from auto-analysis to reading and test sheet preparation are implemented in the one-stop process.

Therapeutic Area	Generic Name	Brand Name	Gene(s)
Anesthesiology	Succinylcholine	Anectine; Quelicin	RYR1/CACNA1S, BCHE
Desflurane	Suprane	RYR1/CACNA1S
Enflurane	Ethrane	RYR1/CACNA1S
Halothane	International use only	RYR1/ CACNA1S
Isoflurane	Forane; Terrell	RYR1/CACNA1S
Methoxyflurane	International use only	RYR1/CACNA1S
Sevoflurane	Ultane	RYR1/CACNA1S
Articaine and Epinephrine	Ultacan; Ultacan Forte	G6PD
Chloroprocaine	Clorotekal; Nesacaine	G6PD
Lidocaine and Tetracaine	Synera	G6PD
Mepivacaine	Carbocaine; Polocaine	G6PD
Oxymetazoline and Tetracaine	Kovanaze	G6PD
Ropivacaine	Naropin	G6PD
Lidocaine and Prilocaine	Lidopril; Prikaan; Oraqix; AgonEaze	G6PD
Lidocaine	Xylocaine; Lidomark 1/5; Lidomark 2/5; P-Care X; Akten; Lidoderm; LMX 4; LMX 5; Topicaine; Lubricaine	G6PD
Mivacurium	Mivacron	BCHE
Cardiology	Carvedilol	Coreg	CYP2D6
Labetalol	Normodyne; Trandate	CYP2D6
Flecainide	Tambocor	CYP2D6
Propafenone	Rythmol SR	CYP2D6
Warfarin	Coumadin; Jantoven	CYP2C9/VKORC1/CYP4F2
Acenocoumarol	International use only	CYP2C9
VKORC1
CYP4F2
Phenprocoumon	International use only	VKORC1
CYP4F2
Irbesartan	Avapro	CYP2C9
Losartan	Cozaar	CYP2C9
Simvastatin	Zocor	SLCO1B1/CYP2C9, APOE
Rosuvastatin	Crestor; Ezallor Sprinkle	SLCO1B1/CYP2C9/ABCG2, APOE
Lovastatin	Altoprev; Mevacor	SLCO1B1/CYP2C9, APOE
Atorvastatin		SLCO1B1/CYP2C9, APOE
Pravastatin	Pravachol	SLCO1B1/CYP2C9, APOE
Fluvastatin		SLCO1B1/CYP2C9, APOE
Pitavastatin	Livalo; Zypitamag	SLCO1B1/CYP2C9, APOE
Aspirin	Ecotrin; Bayer; Asctiptin; Durlaza	CYP2C9
Prasugrel	Effient	CYP2C19/CYP2C9/CYP3A5/CYP2B6
Clopidogrel	Plavix	CYP2C19
Ticagrelor	Brilinta	CYP2C19
Rivaroxaban	Xarelto	F5
Metoprolol	Lopressor; Toprol XL	CYP2D6
Nebivolol	Bystolic	CYP2D6
Acebutolol	International use only	CYP2D6
Betaxolol	International use only	CYP2D6
Bisoprolol	International use only	CYP2D6
Timolol	Betimol	CYP2D6
Propranolol	Inderal; Inderal LA; InnoPran XL; Propranolol HCl Intensol; Inderal XL; Hemangeol	CYP2D6
Mavacamten	Camzyos	CYP2C19
Procainamide		NAT2
Hydralazine	Apresoline	NAT2
Dental	Cevimeline	Evoxac	CYP2D6
Dermatology	Doxepin	Silenor; Zonalon; Sinequan; Prudoxin	CYP2D6/CYP2C19
Abrocitinib	Cibinqo	CYP2C19
Tacrolimus	Astagraf XL; Prograf; Protopic; Envarsus XR	CYP3A5
Fluorouracil	Adrucil; Carac; Efudex; Fluoroplex	DPYD
Endocrinology	Eliglustat	Cerdelga	CYP2D6
Glimepiride	Amaryl	CYP2C9
Nateglinide	Starlix	CYP2C9
Gastroenterology	Dexlansoprazole	Dexilant	CYP2C19
Esomeprazole	Nexium	CYP2C19
Lansoprazole	Prevacid; Prevacid SoluTab	CYP2C19
Omeprazole	Prilosec	CYP2C19
Pantoprazole	Protonix	CYP2C19
Rabeprazole	AcipHex	CYP2C19
Metoclopramide	Reglan	CYP2D6
Dronabinol	Syndros; Marinol	CYP2C9
Ondansetron	Zofran; Zuplenz	CYP2D6
Tropisetron	International use only	CYP2D6
Palonosetron	Aloxi	CYP2D6
Meclizine	Antivert; Bonine; Dramamine Less Drowsy; Motion-Time; Travel Sickness; Travel-Easy	CYP2D6
Sulfasalazine	Azulfidine	NAT2/G6PD
Mesalazine	Apriso; Asacol HD; Canasa; Delzicol; Lialda; Pentasa; Rowasa; SfRowasa	G6PD
Gynecology	Drospirenone and Ethinyl Estradiol	Jasmiel; Lo-Zumandimine; Loryna; Nikki; Ocella; Syeda; Vestura; Yasmin 28; YAZ; Zarah; Zumandimine	CYP2C19
Hormonal Contraceptives For Systemic Use		F5
Elagolix	Orilissa	SLCO1B1
Flibanserin	Addyi	CYP2C19
Hematology	Avatrombopag	Doptelet	F5/CYP2C9/F2
Lusutrombopag	Mulpleta	F5/F2
Eltrombopag	Promacta	F5
Methylene Blue	ProvayBlue; Urolene Blue	G6PD
Immunology	Siponimod	Mayzent	CYP2C9
Cevimeline	Evoxac	CYP2D6
Tacrolimus	Astagraf XL; Prograf; Protopic; Envarsus XR	CYP3A5
Sirolimus	Rapamune	CYP3A5
Azathioprine	Azasan; Imuran	TPMT/NUDT15
Infectious Diseases	Voriconazole	Vfend	CYP2C19
Quinine Sulfate	Qualaquin	CYP2D6
Efavirenz	Sustiva	CYP2B6
Nevirapine	Viramune; Viramune XR	CYP2B6
Abacavir	Ziagen	HLA-B
Dolutegravir	Tivicay	UGT1A1
Raltegravir	Isentress	UGT1A1
Atazanavir and Ritonavir	Available only as generic	UGT1A1
Atazanavir	Reyataz	UGT1A1
Flucloxacillin	International use only	HLA-B
Amikacin	Arikayce	MT-RNR1
Tobramycin	Tobrex; Bethkis; Kitabis Pak; Tobi; Tobi Podhaler	MT-RNR1
Gentamicin	Gentak	MT-RNR1
Kanamycin	International use only	MT-RNR1
Paromomycin	Humatin	MT-RNR1
Plazomicin	Zemdri	MT-RNR1
Streptomycin	International use only	MT-RNR1
Boceprevir	Victrelis	IFNL3/IFNL4
Telaprevir	Incivek	IFNL3/IFNL4
Simeprevir	Olysio	IFNL3/IFNL4
Peginterferon Alfa-2A	Pegasys	IFNL3/IFNL4
Peginterferon Alfa-2B	PegIntron; Sylatron	IFNL3/IFNL4
Ribavirin		IFNL3/IFNL4
Isoniazid	Nydrazid	NAT2
Rifampin, Isoniazid, and Pyrazinamide	Rifater	NAT2
Ethambutol	Myambutol	NAT2
4-Aminosalicylic Acid	Paser	G6PD
Ceftriaxone	Rocephin	G6PD
Sulfadiazine	Silvadene	G6PD
Sulfamethoxazole and Trimethoprim	Bactrim; Septra; Sulfatrim	NAT2/G6PD
Sulfacetamide	Bleph-10; Klaron; Ovace; Sodium Sulfacetamide Wash	G6PD
Sulfisoxazole	Gantrisin Pediatric; Truxazole	G6PD
Sulfadimidine	Available only as generic	G6PD
Sulfamethoxazole		G6PD
Norfloxacin	International use only	G6PD
Nalidixic Acid	NegGram	G6PD
Ofloxacin		G6PD
Furazolidone	Furoxone	G6PD
Neurology	Galantamine	Razadyne; Razadyne ER	CYP2D6
Donepezil	Aricept	CYP2D6
Phenytoin	Dilantin; Phenytek	CYP2C19/CYP2C9/HLA-B
Fosphenytoin	Cerebyx	CYP2C19/CYP2C9/HLA-B
Carbamazepine	Carbatrol; Epitol; Equetro; Tegretol; Tegretol-XR	HLA-B/HLA-A
Oxcarbazepine	Oxtellar; Trileptal	HLA-B
Brivaracetam	Briviact	CYP2C19
Lacosamide	Vimpat	CYP2C19
Deutetrabenazine	Austedo	CYP2D6
Tetrabenazine	Xenazine	CYP2D6
Valbenazine	Ingrezza	CYP2D6
Dextromethorphan and Quinidine	Nuedexta	CYP2D6
Siponimod	Mayzent	CYP2C9
Rimegepant	Nurtec	CYP2C9
Diazepam	Valium; Diastat AcuDial; Diazepam Intensol; Diastat Pediatric	CYP2C19
Clobazam	Onfi; Sympazan	CYP2C19
Midazolam	Nayzilam	CYP3A5
Amifampridine	Ruzurgi	NAT2
Amifampridine Phosphate	Firdapse	NAT2
Lecanemab	Leqembi	APOE
Aducanumab	Aduhelm	APOE
Oncology	Tamoxifen	Soltamox	CYP2D6/F5/F2
Erdafitinib	Balversa	CYP2C9
Gefitinib	Iressa	CYP2D6
Rucaparib	Rubraca	CYP2D6
Belzutifan	Welireg	CYP2C19
Tegafur	International use only	DPYD
Cisplatin	Platinol-AQ	TPMT
Belinostat	Beleodaq	UGT1A1
Irinotecan	Camptosar; Ovivyde	UGT1A1
Sacituzumab Govitecan-hziy	Trodelvy	UGT1A1
Nilotinib	Tasigna	UGT1A1
Pazopanib	Votrient	UGT1A1/HLA-B*5701
Binimetinib	Mektovi	UGT1A1
Fluorouracil	Adrucil; Carac; Efudex; Fluoroplex	DPYD
Capecitabine	Xeloda	DPYD
Mercaptopurine	Purinethol; Purixan	TPMT/NUDT15
Peginterferon Alfa-2B	PegIntron; Sylatron	IFNL3/IFNL4
Thioguanine	Tabloid	TPMT/NUDT15
Flutamide	Eulexin	G6PD
Trametinib	Mekinist	G6PD
Doxorubicin	Adriamycin; Doxil	G6PD
Dabrafenib	Tafinlar	G6PD
Rasburicase	Elitek	G6PD
Ophthalmology	Timolol	Betimol	CYP2D6
Pain Management	Celecoxib	Celebrex	CYP2C9
Lumiracoxib	International use only	CYP2C9
Aceclofenac	International use only	CYP2C9
Flurbiprofen	Ansaid	CYP2C9
Piroxicam	Feldene	CYP2C9
Meloxicam	Anjeso; Mobic; Qmiiz ODT; Vivlodex	CYP2C9
Ibuprofen	Addaprin; Advil Junior Strength; Advil Migraine; Advil; Caldolor; Childrens Advil; Childrens Motrin; Dyspel; Genpril; GoodSense Ibuprofen Childrens; GoodSense Ibuprofen; IBU; Ibuprofen Childrens; Infants Advil ; KS Ibuprofen; Motrin Childrens; Motrin IB; Motrin Infants Drops; NeoProfen; Provil	CYP2C9
Lornoxicam	International use only	CYP2C9
Tenoxicam	International use only	CYP2C9
Diclofenac	Diclozor; Flector; Pennsaid; Voltaren; Xrylix; Cambia; Zipsor; Zorvolex	CYP2C9
Indomethacin	Indocin; Tivorbex	CYP2C9
Naproxen	Aleve; EC-Naprosyn; EC-Naproxen; GoodSense Naproxen Sodium; Mediproxen; Naprelan; Naprosyn; Naproxen DR	CYP2C9
Aspirin	Ecotrin; Bayer; Asctiptin; Durlaza	CYP2C9
Metamizole	International use only	CYP2C9, G6PD
Tramadol	Ultram; ConZip	CYP2D6/CYP2B6/COMT/OPRM1
Methadone	Dolophine; Methadone HCL Intensol; Methadose; Diskets Dispersible	CYP2D6/CYP2B6/COMT/OPRM1
Oxycodone	Oxaydo; OxyCONTIN; Roxicodone; Xtampza ER	CYP2D6/COMT/OPRM1
Hydrocodone	Hysingla ER; Zohydro ER	CYP2D6/COMT/OPRM1
Codeine	Available only as generic	CYP2D6/COMT/OPRM1
Oliceridine	Olinvyk	CYP2D6
Lofexidine	Lucemyra	CYP2D6
Morphine	Arymo ER; Duramorph; Infumorph 200; Infumorph 500; Kadian; Mitigo; MorphaBond ER; MS Contin	COMT/OPRM1
Sufentanil	Dsuvia; Sufenta	COMT/OPRM1
Remifentanil	Ultiva	COMT/OPRM1
Alfentanil	Alfenta	COMT/OPRM1
Hydromorphone	Dilaudid	COMT/OPRM1
Levomethadone	International use only	COMT/OPRM1
Fentanyl	Abstral; Actiq; Duragesic; Fentora; Ionsys; Lazanda; Sublimaze; Subsys	COMT/OPRM1
Buprenorphine	Belbuca; Buprenex; Butrans; Probuphine Implant Kit; Sublocade	COMT/OPRM1
Naltrexone	Vivitrol	COMT/OPRM1
Psychiatry	Sertraline	Zoloft	CYP2C19/CYP2B6
Fluoxetine	Prozac; Sarafem	CYP2D6
Citalopram	Celexa	CYP2C19/CYP2D6
Escitalopram	Lexapro	CYP2C19/CYP2D6
Fluvoxamine	Luvox; Luvox CR	CYP2D6
Paroxetine	Paxil; Pexeva; Brisdelle	CYP2D6
Duloxetine	Cymbalta; Drizalma Sprinkle	CYP2D6
Venlafaxine	Effexor	CYP2D6
Nefazodone	Serzone	CYP2D6
Mirtazapine	Remeron	CYP2D6
Vortioxetine	Trintellix	CYP2D6
Bupropion	Aplenzin; Forfivo XL; Wellbutrin SR; Wellbutrin XL	CYP2B6
Aripiprazole	Abilify	CYP2D6
Aripiprazole Lauroxil	Aristada; Aristada Initio	CYP2D6
Brexpiprazole	Rexulti	CYP2D6
Cariprazine	Vraylar	CYP2D6
Haloperidol	Haldol	CYP2D6
Risperidone	Risperdal	CYP2D6
Paliperidone	Invega	CYP2D6
Iloperidone	Fanapt	CYP2D6
Clozapine	Clozaril; Versacloz	CYP2D6
Zuclopenthixol	International use only	CYP2D6
Perphenazine	Trilafon	CYP2D6
Thioridazine	Mellaril	CYP2D6
Pimozide	Orap	CYP2D6
Doxepin	Silenor; Zonalon; Sinequan; Prudoxin	CYP2D6/CYP2C19
Atomoxetine	Strattera	CYP2D6
Viloxazine	Qelbree	CYP2D6/SLCO1B1
Amphetamine	Dyanavel XR; Adzenys XR-ODT; Adzenys ER	CYP2D6
Modafinil	Provigil	CYP2D6
Pitolisant	Wakix	CYP2D6
Clomipramine	Anafranil	CYP2D6/CYP2C19
Imipramine	Tofranil	CYP2D6/CYP2C19
Trimipramine	Surmontil	CYP2D6/CYP2C19
Amitriptyline	Elavil; Vanatrip	CYP2D6/CYP2C19
Amoxapine	Asendin	CYP2D6
Desipramine	Norpramin	CYP2D6
Protriptyline	Vivactil	CYP2D6
Nortriptyline	Pamelor	CYP2D6
Diazepam	Valium; Diastat AcuDial; Diazepam Intensol; Diastat Pediatric	CYP2C19
Respiratory	Umeclidinium	Incruse Ellipta	CYP2D6
Arformoterol	Brovana	CYP2D6/UGT1A1
Indacaterol	Arcapta Neohaler	UGT1A1
Dextromethorphan	Robitussin; Delsym; Pediacare; Robafen	CYP2D6
Ivacaftor	Kalydeco	CFTR
Ivacaftor, Tezacaftor, and Elexacaftor	Trikafta	CFTR
Ivacaftor and Lumacaftor	Orkambi	CFTR
Ivacaftor and Tezacaftor	Symdeko	CFTR
Rheumatology	Lesinurad	Zurampic	CYP2C9
Allopurinol	Zyloprim	HLA-B
Upadacitinib	Rinvoq	CYP2D6
Azathioprine	Azasan; Imuran	TPMT/NUDT15
Celecoxib	Celebrex	CYP2C9
Lumiracoxib	International use only	CYP2C9
Aceclofenac	International use only	CYP2C9
Flurbiprofen	Ansaid	CYP2C9
Piroxicam	Feldene	CYP2C9
Meloxicam	Anjeso; Mobic; Qmiiz ODT; Vivlodex	CYP2C9
Ibuprofen	Addaprin; Advil Junior Strength; Advil Migraine; Advil; Caldolor; Childrens Advil; Childrens Motrin; Dyspel; Genpril; GoodSense Ibuprofen Childrens; GoodSense Ibuprofen; IBU; Ibuprofen Childrens; Infants Advil ; KS Ibuprofen; Motrin Childrens; Motrin IB; Motrin Infants Drops; NeoProfen; Provil	CYP2C9
Lornoxicam	International use only	CYP2C9
Tenoxicam	International use only	CYP2C9
Diclofenac	Diclozor; Flector; Pennsaid; Voltaren; Xrylix; Cambia; Zipsor; Zorvolex	CYP2C9
Indomethacin	Indocin; Tivorbex	CYP2C9
Naproxen	Aleve; EC-Naprosyn; EC-Naproxen; GoodSense Naproxen Sodium; Mediproxen; Naprelan; Naprosyn; Naproxen DR	CYP2C9
Nabumetone	Relafen DS	CYP2C9
Aspirin	Ecotrin; Bayer; Asctiptin; Durlaza	CYP2C9
Carisoprodol	Soma; Vanadom	CYP2C19
Sulfasalazine	Azulfidine	NAT2/G6PD
Pegloticase	Krystexxa	G6PD
Probenecid	Benemid; Probalan	G6PD
Smoking Cessation	Bupropion	Aplenzin; Forfivo XL; Wellbutrin SR; Wellbutrin XL	CYP2B6
Urology	Tamsulosin	Flomax	CYP2D6
Tolterodine	Detrol	CYP2D6
Fesoterodine	Toviaz	CYP2D6
Darifenacin	Enablex	CYP2D6
Mirabegron	Myrbetriq	CYP2D6
Phenazopyridine	AZO Urinary Pain Relief; Pyridium; Urinary Pain Relief	G6PD
Toxicology	Sodium Nitrite	Nithiodote	G6PD
Succimer	Chemet	G6PD
Dimercaprol	Bal In Oil	G6PD
Supplements	Vitamin C	Acerola C 500; Ascor; BProtected Vitamin C; Fruit C 500; Fruity C [OTC]; Vita-C; VitaChew Vit C Citrus Burst	G6PD
Vitamin K	Mephylon	G6PD
Infectious Diseases/Ophthalmology	Moxifloxacin	Avelox; Moxeza; Vigamox	G6PD

Product specification

	BRCAaccuTest™ PLUS	BRCAaccuTest™
Certification	Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 21-706) CE-IVD RUO*	Korean Ministry of Food and Drug Safety (MFDS) license of in-vitro diagnostic device manufacturing (License No. 17-983) CE-IVD
Compatible platforms	Illumina / MiSeq, MiSeq Dx, MiniSeq, iSeq*	Illumina / MiSeq*, MiSeq Dx
Target enrichment	Amplicon method
Specimen	Blood, FFPE* or tissue biopsy*	Blood
Target genes	BRCA1 and BRCA2
Sequencing reagent and throughput	24 tests/kit - Germline: 1 runs up to 24 samples - Somatic: 1 runs up to 6 samples	24 tests/kit Germline: 1 runs up to 24 samples
Target region	all protein coding regions, splicing regions, selected promoter, UTR, intron regions	all protein coding regions, splicing regions
Target size	22.4 kb (amplicon: 2 pools)	19.8 kb
Turn around time	< 5 hrs
Variants type	SNV, INDEL, Dup, CNV*	SNV, INDEL
Analysis solution	NGeneAnalySys™

*RUO: Reserch Use Only

**CNV: Copy Number Variation