DirectHit is a pharmacodiagnostic test used to determine the

tumor A neoplasm () is a type of abnormal and excessive growth of tissue. The process that occurs to form or produce a neoplasm is called neoplasia. The growth of a neoplasm is uncoordinated with that of the normal surrounding tissue, and persists ...

sensitivity or resistance to

drug A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...

regimen A regimen is a plan, or course of action such as a diet, exercise or medical treatment. A low-salt diet is a regimen. A course of penicillin is a regimen, and there are many chemotherapy regimens in the treatment of cancer. History The work, ' ...

s recommended for the treatment of

breast cancer Breast cancer is cancer that develops from breast tissue. Signs of breast cancer may include a lump in the breast, a change in breast shape, dimpling of the skin, milk rejection, fluid coming from the nipple, a newly inverted nipple, or a re ...

by the

National Comprehensive Cancer Network National Comprehensive Cancer Network (NCCN) is an alliance of 32 cancer centers in the United States, most of which are designated by the National Cancer Institute (one of the U.S. National Institutes of Health) as comprehensive cancer centers. It ...

. It is a noninvasive test performed on small amounts of tissue removed during the original

surgery Surgery ''cheirourgikē'' (composed of χείρ, "hand", and ἔργον, "work"), via la, chirurgiae, meaning "hand work". is a medical specialty that uses operative manual and instrumental techniques on a person to investigate or treat a pat ...

lumpectomy Lumpectomy (sometimes known as a tylectomy, partial mastectomy, breast segmental resection or breast wide local excision) is a surgical removal of a discrete portion or "lump" of breast tissue, usually in the treatment of a malignant tumor or brea ...

mastectomy Mastectomy is the medical term for the surgical removal of one or both breasts, partially or completely. A mastectomy is usually carried out to treat breast cancer. In some cases, women believed to be at high risk of breast cancer have the operat ...

, or core

biopsy A biopsy is a medical test commonly performed by a surgeon, interventional radiologist, or an interventional cardiologist. The process involves extraction of sample cells or tissues for examination to determine the presence or extent of a diseas ...

. DirectHit was developed by CCC Diagnostics Inc., a

biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

company established by former researchers from

Johns Hopkins University Johns Hopkins University (Johns Hopkins, Hopkins, or JHU) is a private university, private research university in Baltimore, Maryland. Founded in 1876, Johns Hopkins is the oldest research university in the United States and in the western hem ...

. DirectHit was launched on 14 January 2010. Currently, it is the only available test for predicting treatment outcomes for

anticancer An anticarcinogen (also known as a carcinopreventive agent) is a substance that counteracts the effects of a carcinogen or inhibits the development of cancer. Anticarcinogens are different from anticarcinoma agents (also known as anticancer or ant ...

chemotherapy Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a type of cancer treatment that uses one or more anti-cancer drugs (chemotherapeutic agents or alkylating agents) as part of a standardized chemotherapy regimen. Chemotherap ...

drugs for breast cancer.

Technology

DirectHit is based on quantitative

immunofluorescence Immunofluorescence is a technique used for light microscopy with a fluorescence microscope and is used primarily on microbiological samples. This technique uses the specificity of antibodies to their antigen to target fluorescent dyes to specif ...

technology Technology is the application of knowledge to reach practical goals in a specifiable and reproducible way. The word ''technology'' may also mean the product of such an endeavor. The use of technology is widely prevalent in medicine, science, ...

. According to recent studies, quantitative immunofluorescence (QIF) can be applied to the standardization of

protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, respo ...

analysis, resulting in increased sensitivity and reproducibility. It is important to be able to quantitate the expression of predictive factors in breast cancer, because response to therapy is often dependent upon the concentration of particular proteins within the tissue. DirectHit utilizes

monoclonal antibodies A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies ca ...

(mAb) corresponding to each

biomarker In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues to examine normal biological processes, ...

to stain the tumor tissue samples. Slides are evaluated with a computerized,

fluorescence Fluorescence is the emission of light by a substance that has absorbed light or other electromagnetic radiation. It is a form of luminescence. In most cases, the emitted light has a longer wavelength, and therefore a lower photon energy, tha ...

microscopy Microscopy is the technical field of using microscopes to view objects and areas of objects that cannot be seen with the naked eye (objects that are not within the resolution range of the normal eye). There are three well-known branches of micr ...

system . Digital images are acquired through a CCCD camera. An algorithm was developed to process and analyze the digital images allowing direct relation between the amount of a specific protein within the

cancer cell Cancer cells are cells that divide continually, forming solid tumors or flooding the blood with abnormal cells. Cell division is a normal process used by the body for growth and repair. A parent cell divides to form two daughter cells, and these d ...

s of the tumor and response to the corresponding drug. Quantitative measurement of up to five signals in a single

cell Cell most often refers to: * Cell (biology), the functional basic unit of life Cell may also refer to: Locations * Monastic cell, a small room, hut, or cave in which a religious recluse lives, alternatively the small precursor of a monastery w ...

can be obtained.

Clinical Trials

The DirectHit Panel for Breast Cancer was validated in retrospective clinical trials conducted at The

University of Maryland The University of Maryland, College Park (University of Maryland, UMD, or simply Maryland) is a public land-grant research university in College Park, Maryland. Founded in 1856, UMD is the flagship institution of the University System of M ...

Greenebaum Cancer Center and Harborview Cancer Center in

Baltimore Baltimore ( , locally: or ) is the List of municipalities in Maryland, most populous city in the U.S. state of Maryland, fourth most populous city in the Mid-Atlantic (United States), Mid-Atlantic, and List of United States cities by popula ...

, MD. One key biomarker was selected as a correspondent to each drug, These biomarkers were identified as playing a significant role in

cancer Cancer is a group of diseases involving abnormal cell growth with the potential to invade or spread to other parts of the body. These contrast with benign tumors, which do not spread. Possible signs and symptoms include a lump, abnormal b ...

processes and as bearing a mechanistic relation to the action of the specified drug. The drug groups used as treatment and their related biomarkers are as follows: Trastuzumab/HER-2/neu, Antiestrogens/Estrogen Receptor, Taxanes/beta-tubulin III, 5FU/Thymidylate Synthase. In these trials DirectHit analysis of

estrogen Estrogen or oestrogen is a category of sex hormone responsible for the development and regulation of the female reproductive system and secondary sex characteristics. There are three major endogenous estrogens that have estrogenic hormonal acti ...

receptor and HER-2/neu displayed a higher predictive accuracy for treatment outcomes with anti estrogen drugs and Trastuzumab than standard methods. In addition DirectHit displayed exceptional predictive accuracy for chemotherapy response (88%). DirectHit also displayed an extreme specificity for predictions of drug resistance (100%).

Cost

The cost of the DirectHit Panel for Breast Cancer is $3500. The use of DirectHit could result in significant cost savings because physicians will be able to customize treatment regimens for patients, eliminating ineffective drugs that would have otherwise been prescribed If a 50% treatment failure rate is assumed for standard chemotherapy, then the use of the DirectHit Test Panel for Breast Cancer could result in potential savings of approximately $466M in drug costs alone for 40,000 late stage cancer patients in the United States. If ancillary costs are also considered, DirectHit testing could result in a total savings of $566M - $666M.

References

External links

Cancer.org

CCC Diagnostics Homepage

Directhittest.com
{{DEFAULTSORT:Directhit Medical diagnosis

Technology

Clinical Trials

Cost

See also

References

Further reading

External links