Roche Launches At-Home PT Self-Testing Product for Anticoagulation Monitoring

Jun 20, 2024 12:04 CST Updated 12:04

Roche

Oncology Drug Research, Development, and Manufacturing

Source:IVD Daily

On May 17, China's National Medical Products Administration (NMPA) published the registration review report of Roche's self-testing coagulation detector and its accompanying consumables.Prothrombin TimeRegistration Evaluation Report of the Test Card.

First, let's learn what PT is?

Prothrombin Time (PT) refers to the time required for plasma to clot when excess tissue thromboplastin and calcium ions are added to platelet-poor plasma, converting prothrombin to thrombin. Prothrombin time is an indicator reflecting the activity of coagulation factors I, II, V, VII, and X in plasma. Prothrombin TimeMeasurement isA screening test for detecting obstacles in the exogenous coagulation system of the body, and also an important monitoring indicator in clinical anticoagulant therapy.

Clinically, the prothrombin time test is not only suitable for the diagnosis of congenital coagulation disorders and acquired bleeding disorders in the extrinsic coagulation pathway, but also has significant importance in diagnosing severe hepatitis and early-stage liver cirrhosis.It is also the preferred test index for monitoring oral anticoagulant therapy in clinical practice.

Clinical Reference Range:

Prothrombin Time (PT): 11~13s

International Normalized Ratio (INR):0.82-1.15

PT Prolongation: PT is considered prolonged if it exceeds the normal control by more than 3 seconds or if the INR exceeds the upper limit of the normal range.
(1) The lack of coagulation factor VII causes an obstruction in the extrinsic coagulation pathway.
(2) Coagulation factors V, X,FibrinogenAnd prothrombin deficiency, causing obstruction in the common coagulation pathway, such as liver disease, obstructive jaundice,Malabsorption SyndromeAnd hypofibrinogenemia, etc.
(3) Increased anticoagulant substances in the blood affect coagulation, such as the presence of coagulation factor antibodies, oral anticoagulants, heparin therapy, and systemic lupus erythematosus.
(4)Fibrinolytic SystemEnhanced vitality relatively weakens the blood clotting effect, such asPrimary HyperfibrinolysisSymptoms, DIC hypocoagulable phase, etc.
PTShorten:Mainly seen in the pre-thrombotic state andThrombotic DiseaseWhen coagulation function is enhanced, such as in the hypercoagulable phase of DIC, myocardial infarction, angina pectoris, cerebrovascular disease, diabetes, and pregnancy-induced hypertension,Deep Vein Thrombosis, nephrotic syndrome, etc.
PT for Monitoring Oral Anticoagulant Dosage:Clinically, an INR of 2-4 is the appropriate range for oral anticoagulant therapy; if INR > 4.5, it suggests reducing or stopping the medication.

The Necessity of Home Self-Testing:

The guidelines for the treatment and management of warfarin indicate that testing PT every two days can effectively maintain the patient's INR within the therapeutic window!

"One Minute to Master Warfarin Efficacy!" This is the slogan of Roche's home-use product.

However, Roche is really fast! The registration certificate only became effective on May 16, 2024, and recently, the editor found that it has been launched on a certain e-commerce platform, selling for 8,000 yuan! It also comes with a lancet and 24 PT test strips.

A single home measurement costs only 333.3333 yuan (including instrument cost)!

If you already have the instrument, each test strip will only cost 1050/24 = 43.75 yuan per time!

The intended use of Roche's home self-test product isFor in vitro detection of prothrombin time in human fresh capillary blood samples, can be used for monitoring the treatment of vitamin K antagonists.

This spares patients from traveling back and forth between home and the hospital, allowing them to self-monitor the effectiveness of oral anticoagulant medications at home and manage the balance of anticoagulation therapy. For patients who need long-term hospital monitoring, this is undoubtedly a great choice!

Of course, the cost-effectiveness of testing in hospitals remains the highest. The editor has listed the PT testing prices in some provinces and cities, and the price differences across regions are still quite significant!

It should be noted that the above prices are based on electrochemical/instrumentation search. For example, the 70 yuan charge in Jiangsu is for the electrochemical methodology.

In the past two years, home blood coagulation testing analyzers from Chinese brands such as Vpoint, Lepu, and Haoshi have also been launched on e-commerce platforms.

This year, respiratory-related testing projects, such as the six respiratory items and pertussis, are also attempting to tap into the potentially huge market of home self-testing. The market needs education, and the market is there. It requires us, the practitioners, to continuously improve product quality, ensure clinical registration, and remember that only good products can be the key to unlocking this market! As for how to define "good," it's up to all of you to explore and develop.

We are all on the road, let's work hard together!

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